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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

This article will explore more elements of unplanned deviations than planned deviations. 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).

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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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How to perform operational qualification – step by step

GMPSOP

In this article, we will explore what operational qualification entails, its importance, and FDA requirements. The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. Also, it can be integrated with other external interfaces.