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What are the elements of quality control process in pharmaceuticals

GMPSOP

OCTOBER 28, 2023

. – 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.

Documentation 52
Documentation Method Validation Packaging Data Entry 52
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How to perform operational qualification – step by step

GMPSOP

JULY 31, 2023

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products.

Documentation 52
Documentation Dosage Labelling Data Entry 52
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