Risk Assessment Guide for Pharmaceutical Excipients

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The primary intent of the IPEC Risk Assessment Guide for Pharmaceutical Excipients (RAG) is to provide  a systematic and scientifically sound methodology for the evaluation of risk to excipient quality and to facilitate more effective and consistent risk-based decisions by excipient makers, distributors, and users.

Guidance is provided herein on “HOW TO” conduct a risk assessment from the perspective of an excipient manufacturer or distributor.

The scope of this guide is to provide excipient suppliers with an overview of risk assessment tools, and
resources that they can use, when conducting risk assessments required by both NSF/IPEC/ANSI 3631
and EXCiPACT™ 2 excipient GMP standards, in order to identify and control for potential risks to excipient quality. The guide provides an overview of: 1) quality risk management, 2) the scientific principles of risk identification and assessment and 3) an outline of the process and use of appropriate risk assessment methodologies. In addition, the guide identifies areas where risk assessments requirements are found in both the NSF/IPEC/ANSI 363 and EXCiPACT™ excipient GMP standards and suggests documentation to demonstrate adequacy of risk assessment and GMP controls.
The IPEC Risk Assessment Guide Part 1 is designed to provide excipient manufacturers and distributors with a common starting point to evaluate risks and develop risk management plans, as appropriate. The guide can help users in assessing their suppliers risk assessment plans. We expect to include additional sections to the risk assessment guide in the future and this edition reflects the first part.

 

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Continue at: http://ipec-europe.org/UPLOADS/IPEC_Risk_Assessment_Guide_FINAL_(May_8_2017).pdf

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