|
As per schedule M-1, the main objectives of GMP are: 1. All manufacturing processes are clearly defined, documented and systematically reviewed and shown to be capable of consistently manufacturing the products of the required quality.
2. All the necessary facilities including the right material, equipment and personal are provided.
3. Standard operation procedures (SOPs) written in clear and simple language and applicable to facilities are available.
4. Critical steps of manufacturing processes and any significant changes in the processes are validated.
5. Operators are trained to carry out the procedures correctly.
6. Records are made during manufacture to show that all the steps in the documented procedures were in fact followed.
7. Records of manufacture and distribution are made in a legible manner and retained in an accessible form.
8. Proper storage and distribution of the products minimizes the risk to their quality.
9. A system is a available to recall any batch found to be unit for sale or use. 10. Complaints about marketed products are examined, the causes of quality defects investigated and measures taken to prevent recurrence.
|
Jun 25, 2008
10:57 PM
|