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Standard Protocol for Deriving and Assessment of Stability – Part 5 Sterile Products

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Topics: Aseptic servicesPreparing

This protocol applies to small molecule products of all presentations, manufactured from non-sterile starting materials and sterilised in their final container.

Introduction

This protocol, presents a standardised methodology to establish shelf life for manufactured sterile products. It is expected that the principles of this protocol are used for local stability trials, stability trials outsourced to third parties and when the validity of published stability data or commercially supplied stability data need to be assessed. Compliance with this protocol should also be sought from product suppliers when products such as Specials are outsourced, and Appendix 2 of this protocol, may be used to support that task.

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Update history

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