Direct Links to important GMP Sterile & Aseptic Processing Guidelines
Certificates of suitability for sterile active substances
Clarification on the acceptability of CEP applications for sterile grade material
WHO Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products
FDA Guidance for Industry: Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
REVISED ANNEX 1 (MANUFACTURE OF STERILE MEDICINAL PRODUCTS) TO GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
WHO good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products (part 2): interpretation of guidelines
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