PDA Survey: 2015 Particulate Matter in Difficult to Inspect Parenterals (single user digital version)

May 2016
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Due to the lack of detailed guidance and best practices for inspection and particle control in difficult to inspect parenteral (DIP) products, PDA has established a technical report team to address particulate matter in difficult to inspect parenterals. As a first step in developing a better understanding of current industry practice with regard to inspection and particle control in DIP products and packages, the team launched a survey. This survey summarizes current practices in the inspection and control of particles in DIP products and packaging materials. Findings include aspects of current processes in manual, semi-automated and automated inspection, along with sampling plans and acceptable quantity limits (AQL) used. Particulate testing and identification, and recent quality and regulatory experiences are also covered. The team will be providing further analysis of the results and recommended practices in the forthcoming PDA Technical Report Particulate Matter in Difficult to Inspect Parenterals.

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Table of Contents

Table of Contents:

Summary of Results
General Information and Demographics
Particulate Matter Identification, Sources, and Mitigation
Difficult to Inspect Finished Product Types, Formulation, and Containers
Acceptable Quality Limit for Statistical Inspection of Visible Particulate Matter in Finished Product
Primary Packaging Suppliers