Standard Operating ProcedurePharmaceuticalSOP-QC-002

Disintegration Test for Capsules

Testing six capsules in the disintegration apparatus at 37 ± 2°C, with the two-stage acceptance criteria, cleaning and records.

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Sections: Purpose, Scope, Responsibilities, Definitions, Safety and GMP, Equipment and Materials, Test Conditions, Procedure, Acceptance Criteria, Deviations, Records, References
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This document is a starting point written to GMP principles. Before use, check it against your own site, products and regulatory requirements, and approve it through your own quality system.