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24 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Process Development modern vision of process validation for pharma- ceutical finished products as described by the main regulatory authorities. Specific examples have been given for sterile liquid and freeze-dried products (Part 1) and solid oral dosage forms (Part 2). The main concept of this new vision is the 'con- tinuum' that has to be created, and demonstrated, during the different stages of product lifecycle. Science and risk-based knowledge represent the key-tool that, starting for the design and develop- Table V. Critical quality attribute (CQA) failure and critical process parameter (CPP) correlation for continued process verification for a solid oral dosage form. CQA failure CPP to be monitored Blending Granulation Tableting Assay • Time • Speed • Spraying pressure/flow rate • Air flow rate during spraying • Spraying temperature • Drying temperature • Loss on drying* • Sieving net dimension • Impeller and chopper speed/time Low probability and impact Degradation products Low probability and impact • Spraying pressure / flow rate • Air flow rate during spraying • Spraying temperature • Drying temperature • Loss on drying* Low probability and impact Dissolution time • Time • Speed • Spraying pressure/flow rate • Air flow rate during spraying • Spraying temperature • Drying temperature • Loss on drying* • Sieving net dimension • Powder/granule dosing • Pre-compression force • Compression force • Tableting speed Hardness Low probability • Spraying pressure/flow rate • Air flow rate during spraying • Spraying temperature • Drying temperature • Loss on drying* • Sieving net dimension • Powder/granule dosing • Pre-compression force • Compression force • Tableting speed Friability Low probability and impact • Spraying pressure/flow rate • Air flow rate during spraying • Spraying temperature • Drying temperature • Loss on drying* • Sieving net dimension • Powder/granule dosing • Pre-compression force • Compression force • Tableting speed Thickness Low probability and impact Low probability and impact • Powder/granule dosing • Pre-compression force • Compression force • Tableting speed Disintegration time Low probability and impact • Spraying pressure/flow rate • Air flow rate during spraying • Spraying temperature • Drying temperature • Loss on drying* • Sieving net dimension • Powder/granule dosing • Pre-compression force • Compression force • Tableting speed Content uniformity • Time • Speed • Spraying pressure/flow rate • Air flow rate during spraying • Spraying temperature • Drying temperature • Loss on drying* • Sieving net dimension • Powder/granule dosing Weight Low probability and impact Low probability and impact • Powder/granule dosing • Tableting speed Uniformity of mass Low probability and impact • Spraying pressure/flow rate • Sieving net dimension • Powder/granule dosing • Tableting speed *Note: CQA measured in process which affects other CQAs.