PDA Survey: 2015 Particulate Matter in Oral Dosage Forms (single user digital version)

Feb 2016
PDA Item Number

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Particulate matter in oral dosage forms has been the subject of customer complaints, recalls and regulatory actions. However, there is currently no clear industry standard or guidance on mitigation, acceptance criteria, clinical relevance, inspection, sampling, testing or acceptable complaint levels for particulate matter in oral products. This lack of a consensus standard is problematic as in the near future drug manufacturers will be submitting quality metrics such as rejection rate, complaint rate, recall rate, right first time, etc., to the United States Food and Drug Administration (FDA).

The intentions of this survey are to document current practices used by drug product manufacturers, active pharmaceutical ingredients manufactures, excipient manufacturers, packaging/primary container manufacturers and consultants/regulators to control, inspect, sample and test particulate matter, intrinsic and extrinsic, in oral dosage forms.

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Table of Contents

Table of Contents:

Summary of Results
General Information and Demographics
Innovators, Generics, Contract Manufacturers & Laboratories
Active Pharmaceutical Ingredient and Excipient Manufacturers
Regulators and Consultants