Good Laboratory Practice
The Good Laboratory Practice (GLP) requirements are mainly for non-clinical health and environmental safety research conducted by test facilities, for the whole process from planning to the final research reports. The purpose of the requirements is to ensure the authenticity and integrity of the research data produced by the test facilities. Moreover, domestic, and foreign competent authorities on chemical products (pharmaceutical products, pesticide products, veterinary drugs, cosmetics products, food additives, feed additives, industrial chemicals, etc.) usually have relevant regulations on the submission of research data for product registration.
Taiwan Accreditation Foundation (TAF), as commissioned by the Bureau of Standards, Metrology and Inspection of MOEA, has developed the "National Good Laboratory Practice (GLP) Compliance Monitoring System", and serves as the GLP compliance monitoring authority. The main task of the monitoring authority is to ensure that the test facilities meet the OECD GLP requirements and comply with compliance registration.
The service of the "National GLP Compliance Monitoring System" is depicted as follows. Please refer to the respetive service programs for details:
- "GLP Registration Service Program for Non-Clinical Test Facilities of the Taiwan Food and Drug Administration of the Ministry of Health and Welfare (TAF-GLP-A03)"
- "GLP Registration Service Program for Pesticide Residue Test Facilities of the Bureau of Animal and Plant Health Inspection and Quarantine, COA, Executive Yuan (TAF-GLP-A04)"
The products applicable to the GLP compliance monitoring system are under the following classification:
A Pharmaceutical products
B Pesticide products
C Veterinary drugs
D Cosmetics products
E Food additives
F Feed additives
G Industrial chemicals
H Medical products
I Others, such as products required by the regulator authorities
The techniques applicable to the GLP compliance monitoring system are under the following classification:
01 Physical-chemical testing
02 Toxicity studies
03 Mutagenicity studies
04 Environmental toxicity studies on aquatic and terrestrial organisms
05 Studies on behavior in water, soil and air; bioaccumulation
06 Residues studies
07 Studies on effects on mesocosms and natural ecosystems
08 Analytical and clinical testing
09 Other tests e.g. harmful effects of drugs or texts shown in the OECD chemical testing
Note: The non-clinical safety research herein referred does not include clinical research or routine quality control (QC) tests in the manufacturing process of chemicals.
ISO/IEC 17025 is a standard suitable for quality control testing. In addition to demonstrating its technical capabilities, laboratories accredited to comply with ISO/IEC 17025 should also demonstrate that they follow good laboratory practice and produce technically valid data.
Regardless of the size, all legally registered domestic test facilities, which could be military, public, private, and academic research institutions and its affiliated entities, can file in applications for GLP compliance registration by the person in charge. The test facility has relevant management and research personnel, use specific equipment in appropriate space, perform non-clinical safety research activities based on established management system, and issue the GLP reports.
Applicants are advised to read the “Guidelines for National GLP Compliance Monitoring System Application (TAF-GLP-A01)” before filing the application to facilitate the accreditation process. Please also refer to the TAF general description of the application process. The relevant documents of the GLP compliance monitoring system can be obtained in the file downloading area of the TAF website.
For any further questions, please feel free to contact the service personnel of the GLP compliance monitoring system program in TAF Laboratory Accreditation Department II.