PDA Visual Inspection Forum 2025 OnSite

PDA Technical Report No. 79, Particulate Matter Control in Difficult to Inspect Parenterals describes best practices for difficult to inspect (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General Chapter <1790>: Visible Particulates in Injection. This Technical Report is intended to provide logical pathways to DIP product inspection and testing to support continual process improvement in the industry.

This technical report aims to provide clear technical guidance for the development and design of a process validation master plan using a risk-based lifecycle approach, and to provide a comprehensive overview of strategies that may be used to validate a manufacturing process or unit operations.

PDA Technical Report No. 78, Particulate Matter in Oral Dosage Forms documents the current practices used by manufacturers of drug products, active pharmaceutical ingredients, excipients, and packaging/primary containers to control, inspect, sample, and test intrinsic and extrinsic particulate matter in oral dosage forms. The scope of this Technical Report includes current practices of monitoring for particulates, as well as recent quality, clinical relevance, and regulatory experience in oral dosage forms.

PDA Technical Report No. 84 (TR 84): Integrating Data Integrity Requirements into Manufacturing and Packaging Operations addresses data integrity from the perspective of manufacturing operations. It discusses regulatory trends, risk management concepts, and recommendations for implementing appropriate data integrity controls in manufacturing operations applicable to paper-based, electronic-based, and hybrid systems. The case studies included in this technical report provide examples of how to assess current data integrity risks and implement the concepts presented in the report.