Amarin_Validation_of_Computerized_Systems

GxP Computerized Systems Validation: A Guide to Preparing the Systems Inventory in Regulated Pharmaceutical Environments

In the pharmaceutical industry, the validation of computerized systems is a regulatory requirement, not an optional best practice. Every system with an impact on the GxP environment — Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice — must comply with applicable quality standards and be properly documented. Without this, [...]

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Cleaning validation in transdermal patch manufacturing — swab sampling and GMP API residue acceptance criteria

Cleaning Validation in Transdermal Patch Manufacturing: GMP Requirements and Best Practices

Cleaning validation in transdermal patch manufacturing is a critical GMP requirement that goes beyond routine equipment cleaning. It is the documented, systematic demonstration that an approved cleaning procedure consistently removes active pharmaceutical ingredient (API) residues — and any other contaminants — to levels that cannot compromise the safety, identity, strength, [...]

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