GMP (Good Manufacturing Practice) is a guideline aimed to control and supervise the medicine manufacture activities worldwide. It is also a necessary permission for pharmaceutical manufacturers to enter the field of international trade.
GMP include: facility, people, site, hygiene, validation, document, production, quality, sale, reuse and inspection etc. It has strict rules of technology, managing system and validation control to prevent: confusion between ingredients, cross infection and contamination from other medicines, variation and deviation from the mix of different components, accidents of missing steps of inspection, faulty operation and other inappropriate process.
The idea of GMP was brought up in the 80s of China and officially announced as the comprehensive and obligatory regulation on July 1st, 1999. In the USA, cGMP (short for Current Good Manufacture Practices) was released in CFR part 210 and part 211 in the 90s.
Overall, the purpose, principle, subject and requirement of Chinese GMP is almost the same as that of American cGMP but there are indeed many differences as follows.
Process of Approval
The certification of Chinese GMP is only a certification for pharmaceutical manufacture permission, excluding the product registration. After the manufacturer is approved for the new product with a registration number, it is able to proceed the application of GMP certification. Moreover, data of three batches of production and data of stability evaluation in at least six months are required submission for product registration or GMP certification.
The certification of American cGMP consists of two parts: Product Development and Chemical Manufacture Control. That means the production registration and manufacture permission is proceeding at the same time. There are two kinds of product registration in the USA: New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). NDA requires data of three batches of production and data of stability evaluation in six months. ANDA requires data of a batch of production and data of stability evaluation in three months. Data of continuous evaluation and validation will be preserved by the manufacturer and declared in the annual report to FDA.
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Post time: Oct-27-2017