Guidelines on cGMP and Quality at Pharmaceutical Products

Section - 1: Basic Requirements of GMP in Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection Section - 2: Application of GMP & Quality for Pharmaceutical Products Manufacture of Sterile Products Manufacture of Liquids, Creams and Ointments Manufacture of Pressurized Metered Dose Aerosol Preparations for Inhalation Good Manufacturing Practices for Active Pharmaceutical Ingredients Quality of Modified or Controlled Released Oral Solid Dosage Forms Computerised Systems Qualification and Validation Validation of Analytical Procedures Certification by Qualified Person and Batch Released Parametric Release Stability Studies Development Pharmaceutics and Process Validation Change Control Incident / Deviation Handling Out of Specification Results Section - 3: Revised Schedule M Good Manufacturing Practices for Premises and Materials Requirements of Plant and Equipment Section - 4: Who GMP: Main Principles for Pharmaceutical Products Quality Management