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GMP is a part of QA that ensures that products are consistently produced and controlled to quality standards appropriate for their intended use and as required by marketing authorization or product specifications. GMP aims primarily to reduce the risks inherent in any pharmaceutical production.
The basic requirements of GMP are:
A All manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently producing pharmaceutical products of the required quality that conform to their specifications.
b. Qualification and validation are performed.
c. All necessary resources are provided.
d Instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided
e Operators are trained to carry out the process properly.
f Records are made during production to show that all steps required by defined procedures and instructions are actually taken and the quantity and quality of product expected; Any significant deviations are fully recorded and investigated.
g Creation and distribution of records, which enable the complete history of a batch to be traced, are retained in an understandable and accessible form.
h. Proper storage and distribution of products minimizes their quality risk.
i A system is in place to withdraw any batch of goods from sale or supply.
j The cause of quality defects in complaints about marketed products is investigated and appropriate measures are taken to prevent recurrence of defective products.
