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Update-on-PDA-TR22-Revisions-for-Aseptic-Process-Simulations

'Update-on-PDA-TR22-Revisions-for-Aseptic-Process-Simulations'
1 PDA: A Global Association 2 Update on PDA TR22 Revisions for Aseptic Process Simulations Anthony Pavell Associate Director, APP Pharmaceuticals 2 3 Agenda ?Definition TR22 ?Why the revision ?What’s Changing ?Conclusions ?Acknowledgements 4 Definition of TR22 ?Initial version published in 1996, replaces: ?Technical Monograph No. 2, Validation of Aseptic Filling for Solution Drug Products, 1980; ?Technical Report No. 6, Validation of Aseptic Drug Powder Filling Processes, 1984 ?Provide a valuable guide to industry in the area of process simulation testing ?Addresses the validation of aseptic processing during formulation and filling activities ?An APS is a simulation of the entire aseptic formulation and filling process, which substitutes a microbiological growth medium for a sterile product. 5 Why the Revision ?Periodic Review – originally published in 1996 ?Develop a modest revision / expansion of PDA TR#22, ?Update / clarify coverage of interventions. ?Address personnel participation in a meaningful and coherent fashion. ?Include an accountability discussion. ?Clarify application to aseptic steps in the drug compounding process. ?Outline execution practice in greater detail. ?Maintain consistency with regulatory guidance (especially FDA’s 2004 AP guide). 6 Important Points to Consider ? APS demonstrates capability, does not determine an SAL. ? Interventions are either: – Inherent – a integral part of the process – Corrective – performed to fix problems ? Interventions must be the focus of the discussion, because contamination is largely associated with them. ? Aseptic process simulation, is not just media filling. 7 Purpose of the APS ?Demonstrate as part of an overall process validation approach, the capability of the aseptic process to produce sterile drug products. ?Evaluate proficiency of aseptic processing personnel. ?Comply with current Good Manufacturing Practice requirements. ?Confirm the appropriateness of operating practices used in support of aseptic processing. 8 What’s Changing – Section 2 PROCESS SIMULATION CONCEPTS AND PRINCIPLES ?No change to typical six month interval ?Providing clarity around worst case conditions ?Present a reasonable challenge to the system without forcing unintentional failure ?Duration is equal to a maximum production run including ?Shifts ?Room/equipment time ?Extremes of container sizes and rates 9 What’s Changing – Section 2 RISK ASSESSMENT ADDITION ?A risk assessment may be performed to determine, identify, and rate the aseptic process steps and interventions, which can potentially adversely affect the sterility assurance of the product. ?These process impacting steps and interventions should be included in the process simulation study. ?Other steps and interventions which do not affect the sterility assurance of the product may be included in the study at the discretion of the company. 10 What’s Changing – Section 3 PROCESS SIMULATION TEST DOCUMENTATION ?Media fills do not support the filtration val
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Update on PDA TR22 Revisions for Aseptic Process Simulations
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