To strengthen and advance the development of qualification accreditation criteria and testing standards for pharmaceutical inspection institutions, the National Medical Products Administration has organized the drafting of a series of documents on qualification accreditation criteria and testing work standards for such institutions, namely: “Qualification Accreditation Criteria and Testing Work Standards for Pharmaceutical Inspection Institutions,” “Testing Work Standards for Traditional Chinese Medicines,” “Testing Work Standards for Chemical Pharmaceuticals,” “Testing Work Standards for Biological Products,” “Testing Work Standards for Pharmaceutical Excipients and Pharmaceutical Packaging Materials,” and “Testing Work Standards for Pharmaceutical Safety Evaluation” (see Attachments 1–6). These documents are now being made public for public comment. Please submit your feedback by email to liuyadan@nifdc.org.cn no later than August 31, 2020. When sending your email, please indicate “Feedback on the Series of Documents on Qualification Accreditation Criteria and Testing Work Standards for Pharmaceutical Inspection Institutions” in the subject line.

　　Contact Persons: Liu Yadan, Xiang Xinhua

　　Contact numbers: 010-53851487, 010-53851353

　　Attachment: 1. Qualification Accreditation Criteria and Inspection Work Standards for Pharmaceutical Testing Institutions

　　　　　2. Standards for Traditional Chinese Medicine Testing

　　　　　3. Standards for the Inspection of Chemical Pharmaceuticals

　　　　　4. Quality Control Procedures for Biological Products

　　　　　5. Inspection Work Specifications for Pharmaceutical Excipients and Pharmaceutical Packaging Materials

　　　　　6. Standard Operating Procedures for Pharmaceutical Safety Evaluation Testing

　　　　　7. Feedback Form for Suggestions and Comments

　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　General Office of the National Medical Products Administration

July 23, 2020

 

 

Appendix 2: Standards for Traditional Chinese Medicine Testing

 

 

Chapter 1: Basis, Terminology, and Scope of Application

Article 1: In order to enhance the scientific rigor and standardization of Chinese medicinal material testing, improve laboratory testing capabilities and management levels, elevate the quality and efficiency of such testing, and strengthen the ability to proactively identify risks to the quality and safety of Chinese medicinal materials, this Standard is formulated in accordance with the “Qualification Accreditation Criteria and Testing Work Standards for Pharmaceutical Testing Institutions” and other relevant laws and regulations.

Article 2: The types of traditional Chinese medicines covered by these Specifications include crude herbs and processed herbal slices, vegetable oils and extracts, formulated granules, compound preparations, and single-ingredient preparations.

Article 3 This Standard serves as the code of practice for testing in the field of traditional Chinese medicine and is applicable to guiding activities related to the testing of traditional Chinese medicines.

 

Chapter 2: Laboratories and Personnel

Article 4 Laboratories shall be staffed with personnel commensurate with their testing activities, ensuring that the professional expertise and number of such personnel are appropriately aligned with the scope and demands of the testing work. Job descriptions shall be prepared for management, technical, and key support personnel involved in testing, specifying their responsibilities in relation to testing activities—including testing operations, result evaluation, method improvement, development and validation of new methods—and, where necessary, clarifying the managerial responsibilities associated with each position. The job descriptions shall also define the required education, qualifications, training, technical knowledge, skills, and experience for each position.

Article 5: Traditional Chinese Medicine specimen museums (or rooms) shall establish standardized procedures for specimen receipt and registration, identification, maintenance and preservation, warehouse access and exit management, retrieval and use, deactivation, and statistical reporting. Specimens shall be classified and shelved in accordance with scientific methods and stored properly. For specimens of precious and fine medicinal materials as well as toxic medicinal materials, a dual-person management system shall be implemented, with annual verification conducted by two designated personnel. Efforts to maintain specimens shall be strengthened to prevent damage caused by natural factors, including temperature, humidity, light, insect infestation, and contamination. A regular safety inspection system shall be established; any identified safety hazards or instances of specimen damage must be promptly addressed and reported, with thorough records maintained.

Article 6 Laboratory personnel shall be capable of conducting testing activities in accordance with prescribed procedures, possess the competence to perform testing and quality evaluation in compliance with the requirements of the applicable Chinese medicinal standards and technical documents, be able to determine, according to established procedures, any existing or potential hazards associated with the tested Chinese medicinal products, and have the ability to assess the associated risks.

Article 7 Drug testing institutions shall define the duties and authorities of all categories of personnel, clearly delineate job positions, and specify the professional knowledge and experience required for each position.

The technical director shall have an educational background in pharmacy or a related field, with a bachelor’s degree or higher, hold a senior professional and technical qualification, and possess at least five years of experience in pharmaceutical testing and at least two years of management experience.

The Quality Manager shall have an educational background in pharmacy or a related field, with a bachelor’s degree or higher, hold an intermediate-level or higher professional technical qualification, and possess at least three years of experience in pharmaceutical testing and at least two years of experience in quality management.

The authorized signatory shall possess an educational background in pharmacy or a related field, with a bachelor’s degree or higher, hold an intermediate-level or higher professional technical qualification, and have at least five years of experience in pharmaceutical testing or pharmaceutical testing management. The individual shall be thoroughly familiar with pharmaceutical testing standards and methods, capable of making accurate judgments and appropriately resolving issues that arise during pharmaceutical testing, and shall be responsible for the test reports they sign.

Inspection personnel shall have an educational background in pharmacy or a related field, with at least an associate’s degree or higher, and possess the requisite knowledge and skills. Individuals who have graduated from non-related fields shall have at least 10 years of work experience in pharmaceutical inspection. Inspection personnel shall be responsible for the inspection work they undertake and for the inspection data and results they issue.

Article 8: Personnel engaged in sampling shall, in accordance with the “Principles and Procedures for Pharmaceutical Sampling,” be thoroughly familiar with the technical specifications for pharmaceutical sampling, accurately master various sampling designs and operational methods, and be proficient in the use of sampling instruments.

Article 9: Personnel responsible for the management of Chinese medicinal specimen collections shall possess relevant professional knowledge in Chinese materia medica, botany, Chinese medicinal material identification, pharmacognosy, or informatics, and shall hold a college diploma or higher.

Article 10 Personnel engaged in experimental work related to the molecular biology of traditional Chinese medicine shall possess an educational background in pharmacy, molecular biology, or a closely related field, have undergone specialized training in laboratory techniques and instrument operation, and meet other requirements for engaging in such experimental work.

Article 11: Personnel who operate special equipment (such as autoclaves, etc.) shall be trained and hold a certificate of qualification for operating such equipment.

Article 12: Personnel engaged in inspection work shall undergo regular training.

Assess and evaluate the training outcomes, and archive the results.

 

Chapter 3 Quality Management

Article 13: Laboratories shall be integrated into the overall quality management system of pharmaceutical inspection institutions and shall enhance and continuously improve their quality management systems through measures such as quality supervision, nonconformity management, corrective and preventive actions, internal audits and management reviews, and complaint handling.

Article 14: The laboratory shall conduct quality activities on a regular basis in accordance with the quality plan to monitor the accuracy, reasonableness, and validity of test results.

Proficiency testing and inter-laboratory comparisons are important external quality assessment activities. Laboratories have the responsibility and obligation to seek out and participate in proficiency testing programs with characteristics specific to traditional Chinese medicine, and should actively engage in such activities.

National regulatory authorities shall organize proficiency testing programs and encourage participation in international proficiency testing programs. The areas of expertise and frequency of participation must meet the relevant requirements (at least once per year). Laboratories accredited by international organizations must also operate in accordance with the applicable international quality management systems.

Article 15: Laboratories shall establish procedures for investigating out-of-specification (OOS) test results. Any abnormal results encountered during testing, including nonconforming test results, must be promptly investigated and analyzed. If the investigation fails to identify the cause of the abnormal result, a retrospective review and hypothesis-testing experiments shall be conducted, typically using the original sample. Each experiment shall modify only one variable at a time to determine the root cause of the nonconformity. If the cause is found to be a laboratory error, corrective or preventive actions shall be initiated immediately. All investigation records shall be documented and retained.

Article 16: With regard to the detection of residual harmful substances, laboratories shall, in light of the characteristics of trace analysis techniques and the technical requirements for risk control, refine standard operating procedures, control analytical costs, eliminate false-positive and false-negative results, and ensure that the results are valid, comparable, and meet acceptable accuracy standards.

 

Chapter 4: Facilities and Environment

Article 17 The floor area of the laboratory shall be commensurate with its functional requirements. Supporting ancillary rooms generally include a macroscopic identification room, a microscopic identification room, a sample storage room, a retained-sample room, a grinding room, a reagent room, a standard substance storage room, a balance room, a high-temperature room, a physicochemical laboratory, a precision instrument room, a molecular biology laboratory, and a specimen collection (room), among others. The testing areas shall be physically separated from the office areas. Testing areas that may interfere with one another shall be effectively isolated to prevent interference or cross-contamination.

Article 18: Traditional Chinese medicinal products with special storage requirements shall be provided with adequate cool-storage, refrigeration, or freezing facilities to ensure their storage under appropriate temperature and humidity conditions.

Article 19: Traditional Chinese Medicine specimen museums (or rooms) shall be housed in dedicated, fixed premises. Such facilities generally include areas for specimen exhibition and display, specimen disinfection, specimen preparation, scientific experimentation, and digitalization, all of which shall be effectively segregated from the specimen storage room. The premises shall be equipped with or implement measures for regulating temperature and humidity, as well as for fire prevention, theft prevention, pest control, dust prevention, and protection against light (including ultraviolet radiation). The storage of flammable and explosive materials, corrosive substances, and any other items that may compromise the safety of specimens is prohibited, and the use of open flames or smoking is strictly forbidden.

Article 20: Special specimens, such as precious and toxic medicinal materials, shall be stored in dedicated storerooms or cabinets.

Article 21: Molecular biology laboratories shall be equipped with distinct functional zones, arranged in accordance with the sequence of the testing workflow as follows: reagent storage and preparation area, sample preparation area, nucleic acid preparation area, amplification area, and amplified product analysis area. To prevent laboratory contamination caused by aerosols and other factors, the pressure differentials among these zones shall comply with the requirements for the experimental environment.

Article 22: Dedicated instruments and consumables for each area of the molecular biology laboratory shall be clearly labeled; cross-use among different areas is prohibited to prevent environmental contamination of the laboratory. Test samples shall be appropriately packaged and clearly labeled to avoid cross-contamination during sample preparation. Molecular biology experiments shall include negative quality-control controls to monitor the experimental environment and positive quality-control controls to monitor amplification efficiency, thereby eliminating false-positive and false-negative results and ensuring the accuracy and reliability of the data.

Article 23: When conducting tests for exogenous harmful residues such as mycotoxins, pesticides, and heavy metals, necessary and appropriate safety protection measures shall be implemented in accordance with the toxicological characteristics and exposure levels of the analytes. Furthermore, essential safety measures must be established for high-risk procedures, including sample grinding, the use of high-concentration reference materials, waste liquid disposal, and the handling of highly contaminated samples, to ensure personnel safety and environmental protection.

 

Chapter 5 Instruments and Equipment

Article 24 Laboratories shall be equipped with the measurement equipment, software, consumables, and auxiliary devices required for testing, including sample preparation, specimen preparation, and data processing and analysis. The management of non-proprietary equipment shall comply with relevant regulations and the requirements of this standard.

Article 25: Traditional Chinese Medicine specimen museums (rooms) are generally equipped with specimen identification and digital information acquisition equipment, such as microtomes, stereomicroscopes, optical microscopes, and digital imaging systems; they may also be equipped with corresponding digital equipment for exhibition and display purposes.

Article 26: Molecular biology laboratories shall be equipped with polymerase chain reaction (PCR) analyzers, centrifuges, refrigerators, laminar flow hoods, autoclaves, forced-air drying ovens, ultrapure water systems, ball mills, gel imaging systems, electrophoresis apparatus, and other instruments and equipment.

Article 27 Laboratories engaged in trace analysis shall pay particular attention to and verify that environmental factors, reagents, and other samples do not adversely affect the validity of test results. Given the stringent requirements for instrument stability and sensitivity, dedicated analytical instruments may be equipped when necessary. In accordance with the characteristics of the residue analysis methods, appropriate cleaning procedures shall be established for laboratory glassware and other equipment used in testing.

 

Chapter 6: Reagents and Reference Materials

Article 28: Reagents used for the testing of traditional Chinese medicines, including standard reagents and reagent kits, shall be subjected to appropriate suitability verification to ensure that they meet the requirements of the test methods.

Article 29 The standard substances for traditional Chinese medicines (including reference standards, reference medicinal materials, and reference extracts) specified in the National Drug Standards and the drug quality standards approved by the Drug Administration Department of the State Council shall be prepared, standardized, stored, and distributed by the National Institute for Food and Drug Control. Laboratories shall give priority to the use of national drug standard substances.

For reference standards, reference medicinal materials, and reference extracts specified in local standards for Chinese medicinal materials and processing specifications for Chinese medicinal decoction pieces, where national pharmaceutical standard substances are insufficient to meet the requirements, the Chinese medicine testing institutions of the respective provinces, autonomous regions, and municipalities directly under the central government shall be responsible for the coordinated planning, preparation, calibration, storage, distribution, and use thereof.

Article 30: Laboratories engaged in the development of reference materials shall formulate a plan for in‑process verification of reference materials and conduct such verifications on a regular basis. They shall also promptly carry out the replacement of batches of reference materials.

Article 31: Certified reference materials shall be used for the intended testing purposes as specified in the certificate of analysis. If used for other purposes, the user shall independently verify their suitability. For certified reference materials with labeled concentrations, once the container is opened, the material should be used up in a single operation; if it is to be used in multiple portions, the user shall independently verify its suitability. Certified reference materials stored at low temperatures shall be allowed to reach room temperature before opening and use.

Article 32: Standard substances that are toxic shall be subject to enhanced safety management. Management systems shall be established for dual-person, dual-lock storage; registration of inbound and outbound shipments; recording of intended uses; and disposal of waste liquids; during the use of toxic standard substances, appropriate personal protective measures must be observed.

 

Chapter 7 Quality Standards and Testing Methods

Article 33 Laboratories shall possess and apply the current, valid versions of national standards, local standards, standards for imported medicinal materials, supplementary testing items and methods, registration standards, methods from authoritative technical organizations, and testing and inspection methods specified in foreign pharmacopoeias that are relevant to the tests being conducted. Where necessary, laboratories may, in accordance with the quality control requirements in place at the time of production of the samples to be tested, adopt the then-current, valid versions of such standards; alternatively, they may, based on customer requirements, select other appropriate standards for conducting the tests.

Article 34: When conducting inspections of Chinese medicinal materials and processed Chinese medicinal slices, if local standards for medicinal materials or processing specifications for Chinese medicinal slices are used, the applicable inspection basis shall be selected.

Appropriate inspection criteria shall be selected for the inspection of imported Chinese medicinal materials.

When employing supplementary testing methods for the inspection of traditional Chinese medicines, the applicable test criteria shall be selected.

Chapter 8: Disposal of Samples

Article 35 Laboratories shall, in light of the characteristics of traditional Chinese medicine samples, establish and maintain management procedures for the receipt, transfer, handling, storage, retention, destruction, or return of test samples, so as to prevent sample deterioration, contamination, loss, or damage. For traditional Chinese medicine test samples that can reflect the quality of the medicinal material or possess archival value, specimens shall generally be retained and stored in a traditional Chinese medicine specimen collection (room).

Article 36: When carrying out sampling tasks, sampling personnel shall conduct necessary on-site inspections of storage conditions and temperature–humidity records. The number of samples shall be in accordance with the relevant spot-check inspection plan or the sampling work implementation plan, and sampling operations shall be conducted in a standardized manner so as not to compromise the quality of the sampled items or the unpacked medicinal products.

Sampling personnel shall inspect Chinese medicinal materials or processed herbal slices for signs of insect infestation, mold growth, contamination, spoilage, and other quality defects. Any issues identified that may affect the quality of the sample shall be documented in the drug sampling record and supporting documentation.

Article 37: Chinese medicinal materials and processed herbal slices shall be sampled in accordance with the “Sampling Methods for Medicinal Materials and Processed Herbal Slices” stipulated in the Chinese Pharmacopoeia. Except in special circumstances, samples shall be taken from intact, unopened packages.

Article 38: Sampling of imported medicinal materials shall comply with the “Sampling Regulations for Imported Medicinal Materials” stipulated in the Measures for the Administration of Imported Medicinal Materials.

Article 39: When accepting samples of traditional Chinese medicinal materials and processed slices, the nature of the material or slice must be clearly specified, and the corresponding testing criteria must be determined. For multi-origin samples, the source should generally be clearly identified in accordance with the relevant standards. For samples of processed slices with multiple specifications, in order to prevent confusion and inconsistency in nomenclature, registration and sample collection may be conducted under the format “Medicinal Material Name (Processed Slice Specification),” and the corresponding testing criteria for the processed slices must be established.

Article 40: Upon acceptance of a re-examination application, the original testing institution may, where necessary, provide an explanation for the issuance of an unsatisfactory test report or a copy of the test records.

Article 41. The accepting personnel shall verify that the pharmaceutical testing institution has inspected the appearance, condition, sealing labels, and other factors of the submitted samples that may affect the test results. For samples requiring special storage and transportation conditions, such as cold-chain preservation, acceptance shall be granted only after confirming that the temperature and humidity records throughout the entire storage and transportation process comply with the relevant requirements.

Article 42: Samples of toxic medicinal materials and processed herbal slices shall be stored in dedicated safes or lockers under a dual-person, dual-lock management system. A designated person shall be assigned to oversee sample management, and a special registration log shall be maintained for the storage of toxic traditional Chinese medicines. Sample receipt shall be subject to dual-person inspection, and all transfers and releases from storage shall be subject to dual-person verification, ensuring that records match physical inventory.

Article 43 Drug testing institutions shall properly retain backup samples for re-examination. For domestically produced drugs (excluding Chinese medicinal materials and processed Chinese medicinal slices), samples that comply with the relevant regulations shall be retained for a period of one year from the date of issuance of the test report or until the expiration of their shelf life, whichever is earlier; samples that do not comply with the relevant regulations shall be retained until the expiration of their shelf life, but in no case longer than two years. For Chinese medicinal materials and processed Chinese medicinal slices, samples that comply with the relevant regulations shall be retained for six months from the date of issuance of the test report; samples that do not comply with the relevant regulations shall be retained until 24 months from the date of issuance of the test report. Samples of imported drugs shall be retained until the expiration of their shelf life.

Article 44: Laboratories shall ensure that the disposal and handling of samples that may pose risks to human health or the environment are conducted in a safe and controlled manner; shall ensure that such discarded samples do not re-enter the distribution chain or are otherwise used; and shall implement appropriate safety measures for waste management to prevent harmful substances from causing harm to human health and the environment. For samples of traditional Chinese medicinal materials and processed herbal slices prior to inspection, crushing operations must be carried out with effective dust-control, explosion-proof, and fire-prevention measures.

 

Chapter 9 Inspection

Article 45 Chinese medicinal material testing includes registration testing, supervisory spot-check testing, evaluative testing, testing of imported medicinal materials, risk monitoring, commissioned testing, and other types of testing.

Article 46. In cases where statutory standard testing methods have not yet been established, testing institutions may, for purposes such as case inspections, accident investigations, emergency response, targeted sampling and testing, and other pharmaceutical safety emergencies, conduct research and develop non-standard methods, including supplementary testing methods, and issue testing reports or data in accordance with the relevant provisions of the State.

Article 47: Laboratories shall, in accordance with prescribed procedures, identify existing or potential hazards associated with the traditional Chinese medicines they test and possess the capability to assess the associated risks.

 

Chapter 10: Reporting and Record-Keeping

Article 48 The laboratory shall be responsible for the information contained in its reports, except for information provided by the client. Inspection reports shall be written in standard characters, with concise and accurate language, and shall be neatly formatted; alterations are not permitted. The report format may refer to the inspection report template (see Appendix).

Article 49: Original inspection records shall be maintained in accordance with the aforementioned specifications. In addition, entries such as “Physical Characteristics,” “Identification,” “Tests,” and “Assay” shall be accompanied by color photographs or spectra, chromatograms, and other relevant visual materials that clearly depict the inspection results.

 

Chapter XI Supplementary Provisions

Article 50: Where the inspection of traditional Chinese medicines involves microbiological and pharmacological experiments, the relevant requirements shall be in accordance with the “Good Laboratory Practice for Pharmaceutical Safety Evaluation.”

Article 51 This Regulation shall be interpreted and amended by the National Medical Products Administration.

Article 52 This Standard shall come into force on the date of its promulgation.

 

Appendix 3: Quality Control Procedures for Chemical Drug Testing

 

 

Chapter 1: Basis, Terminology, and Scope of Application

Article 1: In order to strengthen the standardization of chemical pharmaceutical testing, enhance the testing capabilities and management level of chemical pharmaceutical testing laboratories, improve the quality and efficiency of chemical pharmaceutical testing, and bolster the ability to proactively identify risks to the quality and safety of chemical pharmaceuticals, this Standard is formulated in accordance with the “Qualification Accreditation Criteria for Pharmaceutical Testing Institutions and Standards for Testing Work” and other relevant laws and regulations.

Article 2 This Standard applies to chemical drug testing laboratories conducting chemical drug testing activities.

Article 3: Chemical pharmaceutical testing laboratories and their personnel, in conducting testing activities, shall comply with the relevant laws and regulations of the State, adhere to the principles of scientific rigor, independence, impartiality, and authority, uphold professional ethics, and ensure the authenticity, objectivity, accuracy, and traceability of testing data and results.

Article 4: Chemical pharmaceutical testing laboratories shall assume corresponding social responsibilities and actively participate in the collaborative governance of chemical pharmaceutical safety. While conducting routine testing activities, such laboratories shall give priority to fulfilling inspection tasks related to investigations of chemical pharmaceutical safety cases and emergency responses to chemical pharmaceutical incidents as assigned by relevant government authorities.

Chemical drug testing laboratories shall establish green channels and special procedures for the testing of chemical drugs used in emergency situations, innovative therapies, clinical urgent needs, and rare diseases.

Article 5: Chemical pharmaceutical testing laboratories shall, in accordance with relevant national laws and regulations, implement environmental protection, safety control, and occupational health and safety measures; standardize the management and disposal of hazardous materials, waste, laboratory animals, and other such items; strengthen safety inspections; establish emergency response procedures for testing-related accidents; and thereby ensure the safety of testing operations and public safety.

Article 6: The scope of this Standard covers the types of chemical drugs and the categories of testing activities, including physicochemical and microbiological testing, pharmacological testing, and bioactivity assays for ordinary chemical drugs, biochemical drugs, antibiotics, and special drugs (radiopharmaceuticals, anesthetics, and psychotropic substances).

 

Chapter 2: Laboratories and Personnel

Article 7: Chemical drug testing laboratories shall be equipped with facilities and premises appropriate for their testing activities and shall have independent control over and the right to use such facilities and premises.

Article 8: Chemical pharmaceutical testing laboratories shall be equipped with the instruments and equipment necessary for the proper conduct of laboratory activities, enjoy independent control and use thereof, implement standardized management, and establish and maintain a metrological traceability system to ensure the accuracy and reliability of test results.

Article 9: Chemical pharmaceutical testing laboratories shall ensure the suitability of externally provided products and services, establish and maintain systems and procedures for the selection, procurement, acceptance, storage, and evaluation of such products and services that affect testing quality, and retain records of supplier evaluations as well as a list of qualified suppliers.

Article 10: Chemical pharmaceutical testing laboratories shall be staffed with personnel commensurate with their testing activities, ensuring that the professional expertise and number of personnel are appropriately aligned with the scope and volume of testing work, and that the selection, training, supervision, authorization, and monitoring of personnel are conducted in a standardized manner. The laboratory shall develop job descriptions for all positions involved in testing, clearly outlining the responsibilities of each position as well as the requisite professional knowledge and experience.

Article 11: Chemical pharmaceutical testing laboratories shall strengthen training and assessment of their personnel in areas such as laws and regulations, standards, specifications, operational skills, quality control requirements, laboratory safety and protection knowledge, metrological traceability, and data processing, and shall establish corresponding incentive mechanisms to ensure that the competencies of their personnel continuously meet the requirements of their work.

Article 12: Personnel in chemical pharmaceutical testing laboratories shall be capable of conducting testing activities in accordance with prescribed procedures, possess the ability to perform testing and quality evaluation in compliance with the requirements of the applicable chemical pharmaceutical standards and technical documents, be able to determine, according to established procedures, any existing or potential hazards associated with the chemical pharmaceuticals being tested, and have the capacity to assess the associated risks.

Article 13: Chemical pharmaceutical testing laboratories shall appoint a Quality Manager, a Technical Manager, and an Authorized Signatory, and shall clearly define the respective responsibilities of each.

Article 14: Testing personnel shall have an educational background in chemistry, pharmacy, or a related field, with at least an associate’s degree or higher, possess the requisite knowledge and skills, and be capable of performing the tasks assigned to them. Testing personnel shall be responsible for the test data and results they issue, as well as for their conduct during testing activities.

Article 15: Chemical pharmaceutical testing laboratories may employ permanent staff or contract personnel to ensure relative stability of both personnel and positions. When such laboratories utilize permanent staff, contract personnel, and other relevant personnel, they shall ensure that these individuals are competent and subject to appropriate supervision, and that they perform their duties in accordance with the requirements of the laboratory’s quality management system for chemical pharmaceutical testing. The responsibilities and authorities of on-duty personnel shall be clearly defined, and documented requirements shall be established for the selection, training, supervision, authorization, and competency monitoring of personnel.

Article 16: In accordance with applicable laws and regulations, the qualifications of inspection personnel shall be verified based on their education, training, work experience, and demonstrable competencies; upon successful assessment, they shall be issued a certificate of authorization to perform their duties. Inspection and testing personnel shall only assume their duties upon holding such a certificate and shall carry out specific tasks within the scope of their authorized responsibilities. Chemical drug testing laboratories shall regularly evaluate and confirm the technical competence of their inspection personnel.

Article 17 Personnel engaged in the inspection of special pharmaceuticals such as toxic, narcotic, psychotropic, and radioactive drugs shall undergo training on relevant laws and regulations, safety knowledge, and specialized technical knowledge; those engaged in the inspection of radioactive pharmaceuticals shall obtain a certificate of qualification for post employment issued by the relevant laboratory.

Article 18: Personnel conducting procedures involving laboratory animals shall undergo relevant training and obtain confirmation from their employing institution.

Article 19: Microbiological laboratories shall comply with the requirements for microbial limit tests and sterility testing. The testing process must be conducted in strict accordance with aseptic techniques to prevent cross-contamination and recontamination, and any measures taken to prevent contamination shall not compromise the validity of the test results.

Article 20 Personnel engaged in pharmaceutical microbiological testing shall possess an educational background in microbiology or a related field. Personnel operating specialized equipment (such as autoclaves) shall have undergone training and hold the corresponding certification for operating such equipment.

Article 21: Biochemical pharmaceutical testing laboratories shall conduct biosafety assessments of their biochemical pharmaceutical testing activities and, based on the assessment results, implement necessary biosafety protection measures.

Article 22: Personnel engaged in antibiotic testing shall have no history of antibiotic allergy to ensure their safety.

Article 23: Personnel involved in chemical drug testing laboratories shall undergo regular health examinations, and records thereof shall be maintained.

 

Chapter 3 Quality Management

Article 24: Chemical drug testing laboratories shall establish and maintain a comprehensive quality management system that operates effectively. Risk management shall be integrated throughout the entire quality management process, and appropriate measures shall be implemented in accordance with the level of risk to ensure effective risk mitigation.

Chemical drug testing laboratories that have been accredited by international organizations must also operate in accordance with the relevant international quality management systems.

The conduct of inspections of narcotic drugs and psychotropic substances shall be governed by management systems that ensure the safe handling and use of such substances in laboratory experiments.

Article 25: Chemical pharmaceutical testing laboratories shall enhance and continuously improve their quality management system through measures such as quality supervision, handling of nonconformities and corrective and preventive actions, internal audits and management reviews, and complaint handling.

Article 26: Chemical drug testing laboratories shall, on a regular basis and in accordance with the quality plan, conduct quality assurance activities to monitor the accuracy, reasonableness, and validity of test results.

Article 27 Chemical drug testing laboratories shall develop an annual quality control plan. The quality control plan shall specify the frequency of quality control, cover the principal test and inspection items routinely performed, set limit values, and outline the measures to be taken when such limit values are exceeded.

Article 28. Proficiency testing is an important external quality assessment activity. Chemical drug testing laboratories have the responsibility and obligation to seek out and participate in proficiency testing, and shall actively take part in proficiency testing programs organized by national regulatory authorities, while being encouraged to participate in international proficiency testing programs. The areas of expertise in which participation is undertaken and the frequency thereof shall meet the relevant requirements (at least once per year).

 

Chapter 4: Facilities and Environment

Article 29 The facilities and conditions of chemical pharmaceutical testing laboratories shall meet the requirements of the assigned tasks and ensure the safety of personnel. The laboratory environment shall be clean, hygienic, quiet, and free from contamination. Laboratories conducting tests on special controlled substances such as toxic, narcotic, psychotropic, and radioactive drugs shall implement appropriate safety measures and be equipped with corresponding protective facilities and equipment. When chemical pharmaceutical testing laboratories conduct activities at locations or facilities other than their own, they shall ensure compliance with relevant laws and regulations as well as the aforementioned requirements for facilities and the laboratory environment.

Article 30 The floor area of a chemical pharmaceutical testing laboratory (including laboratory rooms and ancillary rooms) shall be commensurate with its functional requirements, and shall be equipped with a sample retention room that meets the requirements for retaining samples. It shall also have a dedicated area for the proper storage of reference materials in accordance with applicable requirements. The testing area shall be physically separated from the office area.

Article 31: For antibiotic and biochemical pharmaceutical products that are unstable under humid and hot conditions, adequate refrigeration or freezing facilities shall be provided to ensure that samples, reagents, reference standards, and other materials are stored under temperature and humidity conditions that meet the required specifications.

Article 32: Biochemical pharmaceutical laboratories shall, in light of the potential risks associated with samples and the requirements and characteristics of different testing items, establish appropriate environmental control requirements for the respective testing areas to meet biosafety standards and to protect laboratory personnel from potential biological hazards posed by the samples.

Article 33 Chemical pharmaceutical testing laboratories shall, based on their specific circumstances, determine the scope of facilities that require control, develop corresponding management documents, and implement such controls. Where relevant standards, methods, or procedures so require, or where environmental conditions may affect test results, chemical pharmaceutical testing laboratories shall monitor, control, and record these conditions. Environmental conditions—including illumination, power supply systems, temperature and humidity, and atmospheric pressure—shall be appropriate for the requirements of the work being performed to prevent adverse impacts on test quality. Testing areas that may influence one another shall be effectively segregated to prevent interference or cross-contamination. If environmental conditions jeopardize the validity of test or calibration results, work shall be immediately suspended.

Article 34: Animal facilities shall be commensurate with the biosafety level of the laboratory animals used, capable of regulating environmental parameters such as temperature, humidity, air cleanliness, ventilation, and lighting as required, and subject to regular monitoring to ensure that these conditions meet the requirements of the experiments.

Article 35 The location where instruments are placed shall meet the requisite conditions to facilitate their operation, cleaning, and maintenance, and shall be equipped with appropriate dust-proof, shock-proof, ventilation, and dedicated exhaust facilities.

Article 36: Precursor chemicals, explosives precursors, flammable substances, highly toxic substances, and corrosive substances shall be stored and used in accordance with applicable regulations. All types of pressure vessels shall be equipped with safety isolation devices and shall be stored and used as required.

Article 37: Microbiological laboratories shall be equipped with the necessary facilities for microbiological testing, and the laboratory environment shall be maintained in such a way as to ensure the accuracy and reliability of test results. Work areas shall be physically separated from office areas, and areas where antibiotic microbiological assay methods are conducted shall be strictly segregated from the microbiological laboratory itself.

Article 38 Microbiological laboratories shall comply with the requirements of the current edition of the Chinese Pharmacopoeia for sterility testing and microbial limit testing. They shall be equipped with independently configured cleanrooms (areas) or isolation systems dedicated to conducting sterility tests, microbial limit tests, aseptic sampling, and other related activities, as well as with corresponding, separate ancillary areas, including a positive-control bacterium laboratory, a culture room, an observation area for test results, a preparation area for culture media and experimental supplies (including sterilization), a sample reception and storage room (area), a standard strain storage room (area), a waste disposal area, and a documentation processing area, all of which shall be clearly labeled.

Article 39 The layout and operation of microbiological laboratories shall fully take into account the requirements for the installation of laboratory equipment, the microbiological laboratory operating procedures for reagents and pharmaceuticals, and laboratory safety. They must both prevent harm to personnel and the environment during testing and avoid confusion and contamination arising from the experimental process. Cleanrooms shall be equipped with dedicated air-handling units or air-purification systems, with temperature and humidity controlled and recorded; laboratory pressure, illuminance, and noise levels shall meet the needs of testing.

Article 40: All activities in microbiological laboratories shall be conducted within dedicated zones to minimize the risk of cross-contamination and the occurrence of false-positive and false-negative results. Sterility testing shall be performed in a Class A unidirectional-flow cleanroom with a Class B background or within an isolator system, while microbial limit testing shall be conducted in a Class B unidirectional-flow air zone with a background no lower than Class D. Air supply to Class A and Class B zones shall be filtered through terminal high-efficiency particulate air (HEPA) filters.

Article 41: No culture medium showing microbial growth in a microbiology laboratory shall be opened in the sterile area of the laboratory, and the isolation and identification of pathogenic microorganisms shall be conducted in a Biosafety Level 2 laboratory. The establishment, renovation, or expansion of a Biosafety Level 2 laboratory shall be filed with the health administrative authority of the prefecture-level city.

Article 42: The pedestrian and material flow paths in a microbiology laboratory shall be segregated, and control procedures and standard operating procedures for the entry and exit of personnel and materials into and out of clean areas shall be established. Processes and environmental conditions that may affect testing activities shall be effectively monitored, supervised, and documented.

Article 43 Microbiological laboratories shall, in accordance with the relevant national standards, establish comprehensive standard operating procedures for the validation and environmental monitoring of cleanrooms (areas) and containment systems. Written procedures shall be in place for environmental monitoring items and frequencies, as well as for the handling of results that exceed specified limits. Environmental monitoring shall be conducted in accordance with the relevant guidance principles set forth in the current edition of the Chinese Pharmacopoeia.

Article 44: Microbiological laboratories shall establish standard operating procedures for cleaning, disinfection, and hygiene, which shall include the results of environmental monitoring.

Article 45 Chemical drug testing laboratories engaged in antimicrobial potency assays shall be equipped with appropriate assay workrooms. Semi-sterile workrooms shall be fitted with ultraviolet sterilization lamps or other equivalent disinfection facilities to achieve environmental sanitation, and the effectiveness of such disinfection shall be regularly monitored; adequate lighting shall be provided, with illumination fixtures installed at an appropriate height on the side walls; workbenches shall be stable and leveled using a spirit level; and antibiotic contamination within the room shall be avoided. In addition, laboratories for the preparation of test strains shall also comply with microbiological laboratory requirements.

 

Chapter 5 Instruments and Equipment

Article 46: Chemical pharmaceutical testing laboratories shall be equipped with the measurement equipment, software, consumables, and auxiliary devices required for conducting tests and inspections, including sample preparation, data processing, and data analysis. The management of non-proprietary equipment shall comply with relevant regulations and the requirements of this standard.

Article 47: The types, quantities, accuracy, and resolution of instruments and equipment shall meet the requirements for the inspection of various chemical drugs, and sufficient spare parts, replacement components, and accessories shall be provided. Each instrument or its associated apparatus shall be affixed with a unique identification mark and a calibration label.

Article 48: Instruments and equipment that have a significant impact on test results shall be subject to verification (design verification, installation verification, operational verification, and performance verification), shall be calibrated/verified on a regular basis, and shall be documented.

Article 49: An instrument and equipment management file shall be established, the contents of which shall include, at a minimum, the name of the item, model, manufacturer’s name, dates of arrival, acceptance inspection, and commissioning, factory certificates of conformity and calibration/verification certificates, operating manuals, usage records, maintenance records, and details of accessories.

Article 50: Instruments and equipment shall be managed by designated personnel, and their use shall be recorded.

Article 51 For special antibiotics and biochemical drugs, it shall be confirmed that the equipment or its components do not interfere with the test results; where necessary, equipment made of biologically inert materials shall be used. The adsorptive effects of glassware, filters, and other such items on the sample shall be evaluated to minimize their impact on the test results.

Article 52: Sterile instruments required for microbiological testing shall be properly cleaned, packaged, and sterilized, and corresponding standard operating procedures shall be established. Sterile instruments shall be clearly labeled and kept separate from non-sterile instruments.

Article 53: The installation and replacement of biosafety cabinets, laminar flow clean benches, and high-efficiency filters in microbiological laboratories shall be carried out by qualified personnel, and validation shall be performed following such installation or replacement. Biosafety cabinets shall comply with the relevant biosafety standards and be subjected to regular testing to ensure their safe and effective operation; all of the aforementioned equipment shall also undergo periodic revalidation.

 

Chapter 6 Reagents and Reference Materials

Article 54: Inspection laboratories shall be equipped with the reagents required for inspection and testing—including test chemicals, test solutions, test papers, indicators, titration solutions, and laboratory water—and with reference materials, and shall ensure that their quality meets the requirements for use.

Article 55. Testing laboratories shall establish and implement control procedures for the procurement (or preparation and calibration), transportation, storage, acceptance inspection, use, and safe disposal of reagents and reference materials, and shall designate dedicated personnel to manage these activities, so as to ensure their quality and reliability and to prevent contamination, damage, or degradation. Records shall be maintained and retained at each stage.

Article 56: When purchasing reagents and reference materials, qualified suppliers shall be selected, and certificates of quality analysis as well as safety data sheets for hazardous substances and other relevant documentation shall be obtained. Such documents shall be maintained in either paper or electronic form and made readily accessible.

Article 57 Reagents shall be appropriately labeled. Labels for reagents shall clearly indicate the contents, manufacturer, concentration, date of first opening, expiration date (or verification date), and storage conditions. Self-prepared solutions in the laboratory shall be labeled with their name, concentration, preparer, preparation date, and expiration date (or verification date).

Article 58: For standard reagents or reagent kits used in the testing of biochemical pharmaceuticals, appropriate methods shall be employed to conduct suitability verification to confirm that they meet the requirements of the test method.

Article 59: The National Institute for Food and Drug Control shall be responsible for the preparation, calibration, storage, and distribution of reference materials specified in the National Pharmacopoeia (including reference standards, control substances, and reference substances). Chemical drug testing laboratories shall give priority to the use of National Pharmacopoeial reference materials.

Article 60: Laboratories engaged in the development of reference materials shall formulate a plan for in‑process verification of reference materials and conduct such verifications on a regular basis. They shall also promptly carry out the batch replacement of reference materials.

Article 61: Reference materials shall be used for the intended testing purposes as specified in the certificate of analysis. If used for other purposes, the user shall be responsible for demonstrating the suitability of such use. For reference materials of biochemical drugs and antibiotics that are inherently unstable, once the container is opened, the material must be used in a single aliquot and may not be divided for multiple uses; if divided, the user shall be responsible for demonstrating the suitability of such use. Reference materials stored at low temperatures should be used as soon as possible after opening to avoid repeated freeze–thaw cycles, which can lead to a reduction in potency units.

Article 62: The test strains used in microbiological laboratories shall be standard strains obtained from accredited domestic or international strain preservation repositories, or traceable commercial derivative strains that are equivalent to the standard strains in all relevant characteristics.

Article 63 Microbiological laboratories shall be equipped with the necessary facilities and environmental conditions for the preservation and subculturing of microbial strains. Appropriate operating procedures shall be established for the preservation and handling of microbial strains to minimize contamination and alterations in their growth characteristics. The number of subcultures of working strains shall be strictly controlled and shall not exceed five generations (with the standard strain obtained from the strain preservation laboratory designated as the zeroth generation). When necessary, the laboratory shall verify the characteristics and purity of the working strains.

Article 64: Microbiological laboratories shall establish and maintain comprehensive records and supporting documentation pertaining to the acquisition, storage, verification, subculturing, and disposal of microbial strains. Relevant strain-management procedures shall be formulated for each of these stages. Following the destruction of contaminated materials, they shall be uniformly collected and disposed of in a manner that does not adversely affect the environment.

Article 65: The management of laboratory animals shall comply with applicable regulations, and shall at a minimum document the animals’ source, strain, grade, number, date of receipt, identification markings, and quarantine results. Chemical testing laboratories shall centrally retain certificates of quality for laboratory animals, as well as certificates of quality for feed and bedding materials. The disposal of laboratory animal carcasses and waste shall be conducted in accordance with relevant environmental protection regulations, and corresponding disposal records shall be maintained.

 

Chapter 7 Quality Standards and Testing Methods

Article 66: Chemical pharmaceutical testing laboratories shall possess and employ the most recent valid versions of national standards, registration standards, methods published by authoritative technical organizations, foreign pharmacopoeias, or relevant scientific books and journals for the tests and assays they conduct.

Article 67: When developing new analytical methods, chemical pharmaceutical testing laboratories shall conduct method validation to demonstrate that the method is suitable for its intended analytical purpose. When using validated methods developed by other laboratories, method transfer shall be performed to demonstrate that the laboratory has the capability to successfully perform the analytical method. All technical records related to method validation and method transfer shall be retained.

Article 68: When a chemical pharmaceutical testing laboratory uses a statutory testing method for the first time, it shall conduct method validation to demonstrate that the laboratory is capable of performing the method correctly and to confirm the suitability of the statutory testing method for the specific test item. All technical records related to the method validation shall be retained. If the statutory testing method is modified or repurposed, the method shall be re-validated.

Any deviation from the prescribed laboratory testing methods in a chemical pharmaceutical testing laboratory shall be documented in advance, subjected to technical evaluation, authorized, and accepted by the client.

Article 69: Chemical pharmaceutical testing laboratories shall establish and comply with procedures for the control of testing methods, track changes and developments in testing methods, and, upon any revision of standards, promptly revalidate or confirm the relevant testing methods.

Article 70 To ensure the reliability and consistency of test data, standard operating procedures (SOPs) shall be developed for each type of assay as necessary. When conducting assays based on biochemical reactions, attention shall be paid to various influencing factors, including reaction substrates, temperature, reaction time, and reactant concentrations, as well as the impact of operational steps such as grinding, liquid addition, and shaking on the assay results; on this basis, comprehensive SOPs shall be established.

Article 71 When a microbiological laboratory conducts tests using standard methods such as those specified in the Pharmacopoeia, it shall perform method suitability verification. If non-standard methods are used, validation of alternative methods shall be conducted prior to their use, in accordance with the current edition of the “Guiding Principles for Validation of Alternative Methods for Microbiological Testing of Pharmaceuticals” published in the Chinese Pharmacopoeia.

 

Chapter 8: Acceptance and Handling of Samples

Article 72: When a chemical pharmaceutical testing laboratory accepts samples, it shall obtain the necessary information and materials required for conducting the testing, including quality standards, technical documentation, reference materials, and other auxiliary supplies.

Article 73: When a chemical drug testing laboratory, in the course of accepting a testing application or conducting sample testing, discovers that the samples used for testing are false or otherwise inaccurate, it shall refuse to accept the application or terminate the testing and promptly report the matter to the relevant drug regulatory authority.

Article 74: Chemical drug testing laboratories shall, in light of the characteristics of chemical drug samples, establish and maintain management procedures for the transportation, receipt, handling, protection, storage, retention, disposal, or return of test samples, so as to prevent sample deterioration, contamination, loss, or damage.

Article 75: Narcotic drugs and psychotropic substances of the first category shall be stored in secure, dedicated cabinets under a dual-person, dual-lock management system. Designated personnel shall be assigned to manage drug samples, and a special registration log shall be maintained for the storage of narcotic drugs and psychotropic substances of the first category. The storage of other narcotic and psychotropic drugs, toxic drugs, radioactive drugs, and precursor chemicals shall comply with relevant laws and regulations. Drug receipt and acceptance shall be conducted by two persons; circulation and outbound shipment shall be subject to double verification by two persons, ensuring that records match physical inventory. The retention period for the special registration logs shall be no less than five years from the date of expiration of the drugs’ shelf life.

Article 76: Biochemical drugs and antibiotic drugs shall be subject to strict control of environmental conditions during sampling and transportation in accordance with the relevant requirements, and direct sunlight exposure shall be avoided. In addition, biochemical drugs shall undergo pre-processing as prescribed and shall not be subjected to repeated freeze-thaw cycles to prevent impairment of their biological activity.

Article 77: Samples received by the microbiology laboratory shall be in intact packaging and must not exhibit damage, leakage, or missing components. Upon receipt of the samples, the laboratory shall promptly verify and inspect them to ensure that they meet the requirements of the testing, and shall store the samples in accordance with the relevant storage requirements specified in the sample’s instructions for use.

Article 78: The collection of microbiological test samples shall adhere to the principle of random sampling, and sterile techniques must be employed during sampling to prevent microbial contamination of the samples.

Article 79: Chemical drug testing laboratories shall maintain an identification system that enables clear identification of physical samples and associated documentation. Where appropriate, such identification shall be applied to the smallest unit of packaging for the chemical drug. During the period in which a sample is under the responsibility of the chemical drug testing laboratory for testing, the identification shall be retained. The identification system shall ensure that samples are not confused with one another, whether in physical form, in records, or in other documents.

Article 80: Chemical pharmaceutical testing laboratories shall ensure that the disposal and management of chemical substances that may pose risks to human health or the environment are conducted in a safe and controlled manner; shall ensure that discarded samples no longer enter the distribution chain or are reused; and shall implement appropriate safety measures for waste handling to prevent harm to human health and the environment from hazardous substances.

 

Chapter 9 Inspection

Article 81 Chemical drug testing laboratories shall be capable of conducting tests in accordance with national standards, industry standards, supplementary testing items and methods, product technical requirements, and other relevant regulations. Chemical drug testing encompasses registration testing, supervisory spot-check testing, evaluative testing, risk monitoring, and commissioned testing, among others.

Article 82 When a chemical pharmaceutical testing laboratory undertakes supervisory sampling inspections of chemical pharmaceuticals, it shall conduct such inspections in strict accordance with the supervisory sampling inspection plan and the relevant procedural requirements.

Article 83 Laboratories entrusted with the re-examination of chemical drug inspections shall conduct such re-examinations in accordance with relevant laws, regulations, and procedural provisions, and shall issue a re-examination conclusion within the time limit prescribed by the drug regulatory authority. Unless there are legitimate reasons, chemical drug inspection laboratories shall not shirk responsibility for or refuse to accept applications for or mandates of re-examination.

Article 84: When a chemical pharmaceutical testing laboratory undertakes evaluative testing, risk monitoring, or other testing assignments commissioned by relevant government departments, it shall establish corresponding work procedures, implement targeted quality control, and conduct testing and submit results strictly in accordance with the plans, implementation schemes, and designated testing methods stipulated by the commissioning authority. It shall not disclose to the sampled entity in advance any information regarding the testing or its results; it shall not conceal or falsify data or test results; and it shall not release or disclose such data to external parties without authorization.

Article 85: For non-routine testing items, internal quality control measures shall be strengthened, and, where necessary, comprehensive analytical system validation shall be conducted to ensure the reliability and accuracy of the test results.

Article 86: Chemical drug testing laboratories shall establish procedures for investigating out-of-specification (OOS) test results. Any OOS result that arises during the testing process shall be investigated in accordance with these procedures to determine the root cause, with a final conclusion reached and the entire investigation process documented.

Article 87: Testing involving the use of laboratory animals shall adhere to the principles of randomization and control, and only results that meet methodological requirements for error control shall be deemed valid.

Article 88: Due to the unique nature of microbiological testing, the test results shall be evaluated comprehensively and thoroughly, taking into account all microbial conditions and factors that may influence the outcomes. Any deviations arising from operational errors or substandard laboratory conditions must be strictly prevented.

 

Chapter 10: Reporting and Record-Keeping

Article 89: Chemical pharmaceutical testing laboratories shall issue test result reports that are independent, objective, accurate, clear, complete, thoroughly substantiated, and with unambiguous conclusions, and shall affix the dedicated seal for inspection and testing reports to such reports. Where accreditation has been obtained, the laboratory shall also properly use the certification and accreditation mark.

Article 90: The chemical pharmaceutical testing laboratory shall be responsible for the information contained in its test reports. Test reports shall use standardized terminology, be concise and accurate, and be neatly formatted; alterations are not permitted. The report format may refer to the test report template (see Appendix).

Article 91: Chemical drug testing laboratories shall establish and improve a comprehensive document management system covering inspection original records, inspection reports, quality records, contracts, and quality standards, among other documents related to testing activities, and shall implement measures to ensure the security and integrity of archived materials. The retention period for archives shall comply with applicable laws and regulations as well as the requirements for traceability of testing activities.

Article 92: Chemical drug testing laboratories shall establish and maintain record management procedures to ensure that the identification, storage, protection, retrieval, retention, and disposal of records comply with applicable legal and procedural requirements. Chemical drug testing laboratories shall ensure that all records related to testing activities are complete, accurate, and reliable. Furthermore, such laboratories shall archive and retain records of all testing-related activities to ensure the traceability of the testing process.

Article 93: Chemical drug testing laboratories shall establish electronic or paper-based data control and information management systems for the collection, processing, recording, reporting, storage, and retrieval of data. The development of computer systems shall comply with the informationization standards issued by the National Medical Products Administration to facilitate the interconnection and interoperability of regulatory information.

Chemical pharmaceutical testing laboratories shall establish and maintain procedures to safeguard data integrity and security; when using computer systems to create or modify data, they shall ensure data traceability through audit trail functionality or alternative methods; and the archiving of both electronic and paper-based data shall be conducted in a manner that ensures security and ease of retrieval. Chemical pharmaceutical testing laboratories shall also conduct timely, appropriate, and systematic checks on computing processes and data transmission.

Article 94: Chemical drug testing laboratories shall establish and improve a complaint-handling system, promptly address objections and complaints regarding test results, and maintain relevant records.

Article 95: The retention period for inspection records and reports pertaining to narcotic drugs and psychotropic substances of the first category shall be no less than five years from the date on which the drug’s expiration date is reached.

Article 96: Testing involving the use of laboratory animals shall adhere to the principles of “3Rs” — reduction, replacement, and refinement. During such testing, detailed records must be maintained of animal grouping, experimental procedures, observation of clinical signs, measurement of relevant parameters, methods for statistical analysis of data, test results, and conclusions.

 

Chapter XI Supplementary Provisions

Article 97 This Regulation shall be interpreted and amended by the National Medical Products Administration.

Article 98 This Regulation shall come into force on the date of its promulgation.