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Here is a short-list of the most recent Technical Reports:

• PDA Technical Report No. 79 (TR 79) Particulate Matter Control in Difficult to Inspect Parenterals

  This Technical Report is intended to provide logical pathways to DIP product inspection and testing to support continual process improvement in the industry.
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• PDA Research: 2017 PDA PUPSIT Survey (single user digital version)

  PDA conducted a benchmarking survey to better understand the current situation regarding sterile filtration and the implementation of Pre-Use Post Sterilization Integrity Test, or PUPSIT, among large pharmaceutical companies. The survey was open to PDA members with subject-matter expertise in PUPSIT and who hold the manager level position in biologic process development, manufacturing, validation, and/or quality. Readers are encouraged to draw his/her own conclusions from the presented summarized data and responses.

• PDA Technical Report No. 78 (TR 78) 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.
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• 2017 PDA Aseptic Processing Survey

  PDA’s newly revised PDA Technical Report No. 56, Revised 2016 Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance provides an overview of the ideal state for broad good manufacturing practices (GMPs) throughout the product lifecycle and as they become more stringent from the discovery/R&D stage through Phase 3 clinical trials to commercial launch.
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• Points to Consider for Aging Facilities

  PDA's Points to Consider for Aging Facilities takes into account the industry's general thoughts and suggestions of the pharmaceutical manufacturing industry on how to identify and modernize aging facilities.
  Table of Contents