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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
GMP rules have been developed over the last 50 years based on incidents, errors
and disasters in drug manufacture. They represent an accumulated body of past
experiences written down as rules, so that companies do not repeat past
mistakes and put patients at risk.
The GMP rules are there so companies do not learn by trial-and-error. Patients'
lives depend on pharmaceutical manufacturers not making mistakes.
What do the GMP rules say?
US FDA CFR 211
FDA Guidance for Industry Quality Systems Approach to Pharmaceutical
CGMP Regulations
Other CGMP assigned responsibilities of the QU are consistent with modem
quality system approaches (§ 211.22):
Ensuring that controls are implemented and completed satisfactorily during
manufacturing operations
Ensuring that developed procedures and specifications are appropriate and
followed, including those used by a firm under contract to the manufacturer
Approving or rejecting incoming materials, in-process materials, and drug
products
Reviewing production records and Investigating any unexplained
discrepancies
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