药品封装过程性能确认方法分析-analysis of performance verification method for drug packaging process.docxVIP

ABSTRACTIn recent years, validation seems to have become more and more of a scientific discipline in itself. Standard operating procedures dealing with validation have become more and more philosophical, moving away from the operational approach.And as the pharmaceutical companies accepted “validation” as part of the everybusiness, the routine solutions became more and more complex and full of rationales for fulfilling unclear requirements.While “Statistical Methods and Tools for Process Validation” and “ExampleValidation” of the GHTF process validation guidance very clearly and sufficiently suggests installation qualification and operational qualification methodologies for fulfilling the philosophical requirements, the PQ section lacks operational methodology.This paper has developed a risk-based PQ concept base on fundamental requirements by implement the PQ activities on 3ml single piece high speed Penfill packaging line in Novonordisk (China) Ltd. Tianjin site. Stick to the key objective of PQ activity is to demonstrate that the process will consistently produce acceptable products under normal operating conditions, and challenges to the process should simulate conditions that will be encountered under actual manufacturing conditions. Describing a methodology for defining a set-up for PQ runs that simulate normal production in an operational way, including the PQ batch size and the number of PQ runs.It can reduce the batch size of PQ by reasonably analysis the product quantity for each test and the product quantity of stable production, to get the purpose of reducing the cycle time of PQ and saving the resource. For example the traditional PQ method on penfill packaging line needs 200,000pcs each batch, but for the new method only needs 15,000pcs (lower 92.5% down). At same time the entire cycle time reduced down to 3 working days from 10 working days.The another benefit of this PQ method is simplify the qualification revalidation on other similar productio