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What are the elements of quality control process in pharmaceuticals

GMPSOP

. – Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. A standard name and a unique item code define packaging materials.

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How to perform operational qualification – step by step

GMPSOP

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. Pharmaceutical manufacturing operations typically maintain equipment varying from simple balances and scales to complex automated process control and monitoring systems.