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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. – Disintegration Testers (Critical for assessing the disintegration properties of solid dosage forms). Also, it can be integrated with other external interfaces.