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A Standard Protocol for Deriving and Assessment of Stability – Part 1 Aseptic Preparation

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Topics: Aseptic servicesPreparing

This YCD applies to small molecule products of all presentations prepared by aseptic manipulation of sterile pharmaceutical products.

Introduction

The 2007 NPSA (National Patient Safety Agency) alert 20 recommended the supply of ready-to-administer products, at least for high risk injectables, rather than aseptic preparation in clinical areas. The practicality of this is in part reliant on the availability of valid and robust stability data.

This protocol, presents a standardised methodology to establish shelf life for aseptically prepared 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 compounded product suppliers when products are outsourced.  Appendix 2 may be used to support that aim.

Attachments

Update history

  1. Attachment re-secured
  1. Yellow Cover Document revised and new version attached.
  1. Published