Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections.
The Pharmaceuticals and Medical Devices Agency (PDMA) released the new post-approval requirements in a memorandum Friday, expanding on the 2008 list it replaces. No changes were made to the requirements for preapproval inspection applications.
For a post-approval GMP inspection, which takes place every five years, a drugmaker must now submit a review of results from its stability monitoring program and a list of all the types and specifications of water used during manufacturing of the drug, and the frequency of testing of water samples.
The memorandum leaves in place all the existing application requirements, which include:
- Drawings of the manufacturing site layout, including maps of the manufacturing sites and adjacent areas;
- Key details of the quality assurance system, such as a GMP organization chart that shows the roles and duties;
- Manufacturing process flow charts that show the manufacturing methods such as process parameters, specifications and testing methods;
- The latest product quality review conducted within the last two years or separate documents summarizing the review; and
- A review of the raw materials, and packaging and labeling materials used in the approved product.
The memorandum also specifies additional requirements for non-Japanese drugmakers seeking inspection. If the drugmaker resides in a country that has an agreement with Japan, it must submit a GMP compliance certificate issued by the proper regulatory authority.
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