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PDA Technical Report No. 4, (TR 4) Design Concepts for the Validation of Water for Injection System (single user digital version)

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  • Description
  • Table of Contents

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.

This Technical Report was prepared by the QC Subcommittee of the PDA Research Committee.

This publication outlines methods for evaluating a Water-for-Injection (WFI) System for use in pharmaceutical manufacturing. The considerations presented are intended solely as review of factors specific to the design, operation and evaluation of a system generally considered to be capable of consistently delivering WFI. The method described is only one of many possible alternatives of evaluating a system and is limited to the most common method of producing WFI.

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Format: PDF (1 file - 1.23 MB)

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Table of Contents:

  1. Scope
  2. Introduction
  3. Methodology
  4. Addendum
  5. Bibliography
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