1. S.P. SHANI TECHNICAL OFFICER(Drugs) CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (DIRECTORATE GENERAL OF HEALTH SERVICES) MINISTRY OF HEALTH & FAMILY WELFARE, NEW DELHI…

1. Facility Efficiency Regulatory, GMP Challenges Robin Payne (On behalf of the BPOG Room Classification / Closed Systems work stream) ‘Considering the Additional Risks…

Drugs & Cosmetics Act 1940 and Rules 1945 A SEMINAR ONANALYSIS OF SOLID ORAL DOSAGE FORM QUALITY: The regulatory authorities all over the world have accepted that a pharmaceutical…

Slide 1 GMP for Bioprocess primary products. Chapter 5: Primary pharmaceutical production Slide 2 Explain GMP for Reaction and Key Unit Operations Discuss, illustrate GMP…

Introduction Development of oral pharmaceutical drug products presents many technical and regulatory challenges. Speci¢cally, these include proper characterization of active…