This is the first time to revise the Guidelines of Chemical Testing Good Laboratory Practices (HJ/T155 - 2004), when accomplished, it is expected to replace its 2004 old version. This draft standardizes the basic requirements for chemical testing good laboratories to ensure the data quality. It applies to regulate the management and operation of good laboratory, and to instruct the related test institutions in establishing and implementing quality assurance programme when applying for a chemical testing good laboratory. It can also be used for the supervision ministries or institutions in inspection of good laboratories.
The Department of Science, Technology and Standard under MEP is responsible to organize the compiling work. The original drafting committee is the Chemical Registration Center of State Environmental Protection Administration (CRC-SEPA). Now, the drafting committees are Chemical Registration Center of Ministry of Environmental Protection (CRC-MEP), Shanghai Academy of Public Measurement (APM) and Nanjing Institute of Environmental Science (NIES).
The following are some key amendments:
Rename the standard
Supplement and improve terms and definitions and the basic requirements for a qualified laboratory, adding the contents of waste disposal, safety measures for environment and health, emergency response measures, etc.
Take the subcontracting laboratory in Chapter 4.11 of the original standard as a test site to carry out certain stage (or certain portion) of the test, which shall be included into the universal organization and management of multi-site study (Relevant requirements known as the normative Appendix A)
Modify the contents of external assistance and supply in Chapter 4.12 of the original standard with a reference to the Compliance of Laboratory Suppliers with GLP Principles [ENV/JM/MONO(99)21], which is the No.5 document in the series of documents concerning OECD GLP principles and compliance monitoring.
Delete the Chapter 4.13 of the original standard concerning appeal or complaint


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Original regulatory document
