PDA Survey: 2014 Visual Inspection (single user digital version)

Oct 2015
PDA Item Number

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Visual inspection continues to be a critical step in the manufacture and release of high quality injectable medicines. There is limited specific guidance on inspection methods or acceptance criteria which has led to a wide range of industry practices. This diversity is also to be expected given the variety of products and packages currently being manufactured and thus inspected. In recent years we have also seen increased interest and activity by the regulatory authorities in this part of the process, providing additional incentive for consistent practices. In August of 2014, the fourth survey in a series of surveys was launched by PDA to better understand and document current industry practices in this important area. Past PDA Visual Inspection surveys in 1996, 2003 and 2008 have provided practical guidance and insight to those working in this field. The purpose of this survey was to document current industry practice for visual inspection of injectable products.

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Table of Contents

Table of Contents:

General Information
Manual Inspection
Automated Inspection
Inspection Results
Acceptance Sampling and Inspection Strategies