Differences Between American CGMP and Old Chinese GMP (Part II)

Level of Details

In the USA, GMP’s principles have been covered in part 210 and part 211 of the code of federal regulations. Because these regulations are hard to amend or add, FDA has released different documents of GMP regulations and operation guidance for pharmaceuticals, such as Guidance for Industry. These constantly amended and added files are called CGMP guidelines. Some of these guidelines relate to new drug research and registration, such as ICH (Q1-Q10). How to conduct method validation, process validation and other contents about GMP were also included in these documents, which are the standards complied with in the GMP on-site inspection. In addition, some guidelines are released for GMP inspectors as references, such as Guide to Inspections of Dosage Form Drug Manufacturers, Guide to Inspections of Quality Systems, Validation of Cleaning Processes etc. It is not compulsive to use these guidelines. Because only FDA inspectors are authorized to decide whether the operation process of the manufacturer meets this “current” standard, the drug manufacturers has to follow the latest cGMP and other guidelines and check on themselves to see if the standards have been conducted. Otherwise, they would be considered as “not approved” and get penalized for it.

 Chinese GMP (1998 edition) is too simple and vague, lacking specified guides and requirements in accordance with GMP principles. In the appendix of 1998 edition GMP, six types of drugs were brought up with brief guidelines. So far, there is still blank in GMP providing operation guiding references. Equipment qualification and validation, process validation, method validation, sterilization validation and other specific operation methods have been conducted without detailed standards, which causes a backward management.

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