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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...

PRODUCT DEVELOPMENT & PRODUCTION SYSTEMS
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...