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Content of our procedures are not only guidelines but detail know how instructions which will help you to build up your systems from scratch.

validating cleaning procedures in biopharmaceutical manufacturing facilities-27

The RAL of peculiar residues that are most likely to cross-contaminate following production lines are estimated, validated and used as a reference to determine the effectiveness of any cleaning protocol.

This has had a direct impact on the pharmaceutical cleaning validation process particularly about regulatory requirements; the more complicated the manufacturing procedure, the more difficult it is to clean equipment surfaces to meet regulatory standards.

So rather than view cleaning validation as a mere ‘clean-up’ after manufacturing, stakeholders in both academia and the industry have started to consider it as a form of manufacturing on its own.

Forms and templates are referenced in the SOPs where applicable.

Procedures and manuals are grouped into categories found in a typical GMP environment and documents are prepared to guide you through establishing a regulatory compliant facility.




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