Pharma API-Useful Links: APIC guidelines series_Regulatory starting material APIC POSITION PAPER ON THE DEFINITION OF ACTIVE SUBSTANCE CEFIC/APIC Position on Post-Approval Change Authorization Procedures (PACAPs) relating to the manufacture of APIs CEFIC/APIC Position on the “Procedure for the Certification of Suitability to the Monographs of the European Pharmacopoeia” (CEP Procedure) versus the “Drug Master File Procedure” (DMF Procedure) Need for GMP for API production Process Validation: General Principles and Practices -USFDA European Medicines Agencies-Guideline on the chemistry of active substances Questions and answers on level of detail in the regulatory submissions Questions and Answers on Design Space Verification QbD: A Global Implementation Perspective The EU Perspective