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Covering a wide variety of manufacturing types, the ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation is a reference of technical and scientific detail to help organizations conduct process validati...

Process Validation

An ISPE survey of compounding pharmacies and regulators overwhelmingly demonstrated that 503B outsourcing facilities could benefit from comprehensive guidance summarizing regulatory requirements. The ISPE Guide: 503B Compounding - Regulatory Basis...