Publications
Technical Reports
PDA Technical Reports are highly valued membership benefits. They are global technical documents, prepared by member-driven Task Forces comprised of content experts, including scientists and engineers working in the pharmaceutical and biopharmaceutical industry, regulatory authorities and academia. Current Technical Reports address a wide array of challenging technical areas, including use and validation of pharmaceutical filters, sterilization technologies, non-conformities in glass vials and ampoules, pharmaceutical microbiology, glass defects, process validation and good distribution practices, including cold chain, and quality risk management.
Every PDA members receives the opportunity to download new technical reports free of charge within 30 days of publication as part of their regular membership benefits.
Here is a short-list of the most recent Technical Reports:
This PDA technical report provides guidance on how to detect and mitigate TBA and TCA odors and taints. Well recognized in the food and beverage industries, the literature features knowledge from these industries regarding the origin of these odors and taints, analytical methods developed, and risk management strategies employed. In 2009, this became an issue for the pharmaceutical and consumer healthcare industries with product recalls from four companies due to the risk of product exposure to the TBA taint from tribromophenol-treated wood pallets. Recalls from additional firms continued through 2011.
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PCMO SM PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides detailed guidance for the application and implementation of quality risk management (QRM) principles throughout the product lifecycle. Intended to align with ICH Q9 and present information that can be helpful to the reader on how to implement QRM, the report emphasizes QRM application during commercial manufacturing and integrating QRM into the pharmaceutical quality system.
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PDA Technical Report No. 22 (Revised 2011), Process Simulation for Aseptically Filled Products, originally published in 1996
The Task Force charged with updating the document ensured that the new version reflects the continuing changes that have occurred in aseptic processing technology within the global industry over the last decade and a half. They have attempted to address the subject as fully as possible, recognizing the notable contributions by other organizations, regulators, compendia and individuals who have worked in this area. In addition the report provides guidance where risk-based approaches may be applied.
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Product shipping and storage introduces risk to the stability of drug products. PDA Technical Report No. 53, Guidance for Industry: Stability Testing to Support Distribution of New Drug Products will help any drug manufacturer provide a scientific rationale for the stability testing done to ensure the quality of drug products during shipping and storage, including excursions from temperatures outside recommended range. Stability is the first of seven pillars of Good Distribution Practices, the first four of which is covered generally in PDA Technical Report No. 52: Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain (August 2011).
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This technical report describes the overall quality system for distribution of pharmaceutical products and is meant to assist manufacturers in assuring that quality, integrity, and efficacy of the product are not compromised in the distribution channels, including handling, storage, transportation and distribution. It applies to all parties involved, including, but not limited to, the manufacturer, the holder of the marketing authorization, third party Logistics Service Providers (termed 3PLs), wholesale distributors, and transportation carriers.
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TR 51 Provides a comprehensive review of an area not adequately addressed in current guidance documents: recommended specifications for BI to be used with sporicidal gas and vapor-phase decontamination cycles together with guidance regarding their manufacture, quality control, and use. 2010.
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PDA Technical Report No. 50 Alternative Methods for Mycoplasma Testing
A PDA Task Force of experts has developed PDA Technical Report No. 50, Alternative Methods for Mycoplasma Testing to help your analytical lab feel confident in the use of alternative methods. The report focuses on non-culture testing methodology, including Nucleic Acid Amplification Technique (NAT) assays and enzyme activity based assays. Representatives of the U.S. FDA and the U.S. Pharmacopeia contributed to the report.
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