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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. Pharmaceutical manufacturers must integrate the key functions of the quality control process.

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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

It is important to understand that everyone in the pharmaceutical manufacturing facility is responsible for reporting a deviation as soon as one is identified. incorrect data entry). Example: An incorrectly spelled product name on the manufacturing instructions can be classified as a minor deviation.

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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.