Important Ideas and Facts:
Scope: While focusing on sterile products, the Annex 1 also highlights that its general principles can be applied to other areas where contamination control is crucial.
Investigation of Non-Conformities: All deviations, including sterility test failures and environmental monitoring excursions, must be thoroughly investigated to determine root causes and potential impact on product quality.
Transfer of Materials: Movement of materials between different cleanroom grades requires stringent controls and a documented disinfection program.
Glove Integrity: Routine glove integrity monitoring is mandatory, with specific requirements for visual inspection and frequency based on the type of aseptic processing.
Cleanroom Classification: The Annex 1 provides updated tables for maximum permitted particle concentrations for each cleanroom grade, both at rest and in operation.
Aseptic Process Simulation (APS): APS must be comprehensive, simulating the entire aseptic manufacturing process, including worst-case scenarios. The frequency, number of units, and media selection must be scientifically justified.
Sterilization: Terminal sterilization is preferred when possible. Various sterilization methods are discussed in detail, including steam, dry heat, radiation, and ethylene oxide. Validation requirements and critical process parameters are outlined for each method.
Sterile Filtration: When terminal sterilization isn't feasible, sterile filtration is necessary. The Annex 1 provides guidance on filter selection, validation, integrity testing, and process considerations.
Lyophilization: The lyophilization process and equipment must be designed and validated to maintain sterility. The Annex 1 addresses critical aspects such as lyophilizer sterilization, loading procedures, and environmental control.
Conclusion:
The 2022 revision of EU Annex 1 introduces significant changes to ensure the highest levels of sterility assurance in medicinal product manufacturing. A robust CCS, a strong PQS, and adherence to the detailed guidance provided in the Annex are crucial for successful implementation of these requirements.
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
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