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GMP Guide
Documenation
Standard Operating Procedure
FDA
Process Validation
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GMP Guide
Overview
Guide for Documentation and Records
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What is a Standard Operating Procedure
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Overview about one of the most important and biggerst Health Agencies in the world. The FDA - The Food and Drug Administration
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This guide describes the requirements for carrying out validation of drug substance and drug product manufacture including packaging processes. Prospective, concurrent and retrospective validation are included together with sampling, testing, inspection, minimum batches, key intermediate / critical process step concept, yield changes and preparation of validation master plans, protocols and reports.
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