In accordance with the new Pharmaceutical Affairs Law (PAL), which went into effect on April 1, 2005, the Ministry of Health, Labor, and Welfare (MHLW) issued an update on Good Laboratory Practice (GLP) in Notification 0331030. This notification clarifies that GLP is applied to non-clinical laboratory studies that determine the safety of medical devices. These studies are limited to the collection and preparation of data concerning biological safety that are performed by using test systems at testing facilities. GLP does not cover quality assurance or sterilization validation studies.
The new GLP clearly outlines the responsibilities of the test facility and necessary personnel. The test facility must first designate the necessary personnel, including the study director and Quality Assurance (QA) director, before beginning the study. In addition, the test facility develops standard operating procedures (SOPs), approves the study protocol, and maintains all study records. The study director must develop the study protocol, ensure that the study is conducted in accordance with the protocol and SOPs, and submit all final reports. The QA manager maintains all of the records for each test conducted at the test facility, and confirms that the information has been generated in accordance with GLP. The QA manager also advises the test facility and study director on quality issues. Finally, it is important that the medical company sponsoring the test be aware that it is responsible for informing the test facility, study director, and QA manager of any updates on GLP compliance.
The new GLP also clarifies the definitions for test articles and control articles. Test articles are defined as any medical devices, raw materials (including chemical or biological substances), extracts, or any product subject to a safety assessment. Control articles refer to any medical devices, raw materials (including chemical or biological substances), extracts, or any product that will be tested in comparison to the test article.
Since the definition of test and control articles in Japan includes extracts, it is desirable for stability studies to also be conducted on any extracts. However, it is generally difficult for the testing facility to conduct this stability study. Therefore, the new GLP states that a stability study on extracts should be conducted only if performing this test is feasible. In contrast, according to U.S. GLP requirements, extracts are not included in the definition of test and control articles. This is one example of how Japanese GLP requirements are actually more detailed than U.S. GLP requirements.