Title 03 2425 PICs Guide to GMP for Medicinal Products UPDATED.pdf ✅

For PH-PHR 316 students ONLY. Approval of the PH-PHR 316 Lecturer must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. cademics. ouches heart. ducates mind. rticulates vision. odels excellence. A T E A M The Pharmaceutical Inspection Cooperation Scheme (PIC/s) Guide to Good Manufacturing Practice (GMP) for Medicinal Products Maria Teresa T. Basilides, RPh, MS Dr. Mariano Que College of Pharmacy De La Salle Medical and Health Sciences Institute PH-PHR 316 A.Y. 2024-2025
For PH-PHR 316 students ONLY. Approval of the PH-PHR 316 Lecturer must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. Learning Objective • Explain the salient points of PIC/s guide to GMP of medicinal products. PH-PHR 316 Pharmaceutical Manufacturing (with Quality Assurance and current Good Manufacturing Practices
For PH-PHR 316 students ONLY. Approval of the PH-PHR 316 Lecturer must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. FDA A.O. No. 2012-008 PH-PHR 316 Pharmaceutical Manufacturing (with Quality Assurance and current Good Manufacturing Practices
For PH-PHR 316 students ONLY. Approval of the PH-PHR 316 Lecturer must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. Revision of PIC/S GMP Guide (PE 009-14) PH-PHR 316 Pharmaceutical Manufacturing (with Quality Assurance and current Good Manufacturing Practices • Geneva, 20 June 2018: the following Chapters and Annex of the PIC/S GMP Guide have been revised: • Chapter 3 on “Premises and Equipment”; • Chapter 5 on “Production”; • Chapter 8 on “Complaints and Product Recall”; • Annex 17 on “Real Time Release Testing and Parametric Release“.