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1、Validation of Pharmaceutical Packaging,S. P. Manek Ph.D ( Tech ) 08-10-2011,1,Validation : Regulatory Compliance,Validation a Key requirement of all GMP Guidelines Process Validation Cleaning Validation Analytical Methods Validation Computer systems validation Facility / Equipments Validation / Qual
2、ification ( IQ/OQ/PQ ) Packaging Validation : to confirm that the resulting product from a specified packaging process consistently conforms to product attributes & requirements. A risk-based approach - focusing on processes that have the greatest potential risk to product quality provides a rationa
3、l framework for developing an appropriate scope for validation activities.,2,Validation : Packaging Operations,US-FDA and EMEA Regulatory compliance equipment must be suitable for its intended use. need to validate packaging machines / their various component Validation process: technically complex,
4、 time consuming, costly Key Elements : Qualification of equipments : all relevant sub-systems are thoroughly tested and documented to provide the information that is essential for successful validation. Validation of a Product Packaging operation PQ : verification of facility, utilities, equipment p
5、erformance, components, trained personnel and processes Evaluation of variance & Assessment of impact on Critical Product Quality attributes Cleaning validation : Part of Packaging Validation,3,Validation,Qualification or Validation? Qualification and validation are essentially components of the sam
6、e concept The term qualification is normally used for equipment, utilities and systems : A system must be qualified to operate in a validated process The term validation is normally used for processes In this sense, qualification is part of validation, e.g. you qualify an autoclave, whereas you vali
7、date a sterilization process Qualification should be completed before process validation is performed,4,Validation : Packaging Operations,A validated process: enables consistent packaging of products to meet the product / market requirements - Quality attributes/consumer needs - in a cost effective
8、& an efficient process with minimum down time, rejects and errors. Consistency & Cost effectiveness - key business considerations, a validation activity should be seen not as a regulatory requirement but as a business necessity Multi-disciplinary effort: equipment engineers, packaging technologists
9、and quality teams must plan and work through a validation program together in order to create a robust operation & ensure consistent Quality packaging,5,Packaging,Packaging : “the art, science and technology of preparing goods for sale in a cost effective manner.” Filling, Sealing, Inspection, Label
10、ing, Final Packaging In the context of pharmaceuticals, the packaging must: preserve the product - from degradation or contamination contain the product - to avoid leakage identify the product - providing traceability, security - against tampering and counterfeiting information on use - an “aide mem
11、oir” for compliance convenience in use - for medical staff or patient All this must be ensured for the life of the product and achieved within a complex regulatory environment.,6,Packaging Validation : Pre-requisites,Key areas impacting the robustness of a packaging process - should be considered in
12、 validation: Packaging equipment & Line Layout / Facility space Packaging materials SOPs : Equipment Operation, Maintenance, Cleaning Calibration Program Operator Training Master Validation Plan Packaging Equipment IQ/OQ/PQ & Validation Protocols,7,Validation :Packaging Line Layout,The design and la
13、yout of equipment has major impact on the efficiency of the packaging line. Line Layout : Design for a line layout should include the ability to manage quick change-over, perform line clearance between batches of product and clean the line in an easy and controlled manner. The majority of problems o
14、n packaging lines are related in some way to poor line clearance - important to design these problems out. Devices will normally be located in critical positions on the line to detect presence or otherwise of the materials. The layout should provide easy access for operators and the engineers for adjustments and or maintenance,8,