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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. – Archive records so that they are protected, secured, and easily retrievable.

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. – Disintegration Testers (Critical for assessing the disintegration properties of solid dosage forms). 90% to 110% of the label claim). are functioning as expected.

Documentation 52
Documentation Dosage Labelling Data Entry 52
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