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PDA Technical Report No. 49 Points to Consider for Biotechnology Cleaning Validation
The Technical Report aligns cleaning validation practices with the life cycle approaches to validation, as enabled by the International Conference on Harmonisation guidelines on pharmaceutical development (Q8), quality risk management (Q9) and quality systems (Q10).
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PDA Technical Report No. 48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance
PDA Technical Report No. 48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance addresses moist heat sterilizers intended for use in the pharmaceutical, medical device and biotechnology industries.
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PDA Technical Report No. 47: Preparation of Virus Spikes Used for Virus Clearance Studies
PDA Technical Report No. 47: Preparation of Virus Spikes Used for Virus Clearance Studies represents the efforts of an international task force to define the quality attributes that may be applied to virus and bacteriophage spike preparations, as well as to cell lines used for virus propagation and sample testing.
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PDA Technical Report No. 46 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User
PDA Technical Report No. 46 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User has sorted through the various distribution regulations in major markets to provide guidance on the proper handling of controlled-temperature medicinal products and devices along the final legs of the distribution chain. 2010. 38 pages.
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PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications
PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications, updates the 1992 original version of Technical Report No. 15 in response to the substantial changes that has occurred in industry since then, including improvements to processing equipment, introduction of new technology and materials, and publication of substantial new guidance on validation.
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PDA Technical Report No. 26, Revised 2008, Sterilizing Filtration of Liquids
Supplement Volume 62 No. S-5
PDA’s original Technical Report No. 26, published in 1998 described the use and validation of sterilizing filtration to a generation of pharmaceutical scientists and engineers. This revision was developed in response to enhancements in filtration technologies and recent additional regulatory requirements within the pharmaceutical industry. It underwent an eleven-week global technical peer review that included feedback from the Americas, Asia-Pacific and Europe. 2008. 62 pages.
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PDA Technical Report No. 41, Revised 2008 Virus Filtration
Supplement Volume 62 No. S-4
The 2008 revision expands the original report to cover best practices for filter qualification and validation of filters designed to remove viruses 20 nm in diameter and larger. 2008. 62 pages.
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PDA Technical Report No. 14, Revised 2008 Validation of Column-Based Chromatography Processes for the Purification of Proteins
Supplement Volume 62 No. S-3
Provides a current industry perspective and scientific guidance on the validation of column-based separation processes for the purification of biopharmaceutical proteins. 2008. 38 pages.
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PDA Technical Report No. 45, Filtration of Liquids Using Cellulose-Based Depth Filters
Supplement Volume 62 No. S-2
Provides a current industry perspective and scientific guidance on the validation of column-based separation processes for the purification of biopharmaceutical proteins. 2008. 38 pages.
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PDA Technical Report No. 44, Quality Risk Management for Aseptic Processes
Supplement Volume 62 No. S-1
Provides an overview of a quality risk management program and to present a model to facilitate the risk assessment of aseptic processing of sterile products. 2008. 42 pages
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Best Sellers
Top 10 Bestsellers - Updated as of March 2010 quarterly!
1) PDA Technical Report No. 1, Revised 2007, Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control
2) PDA Technical Report No. 44, Quality Risk Management for Aseptic Processes
3) PDA Technical Report No. 43, Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing
4) PDA Technical Report No. 41, Revised 2008 Virus Filtration
5) PDA Technical Report No. 14, Revised 2008 Validation of Column-Based Chromatography Processes for the Purification of Proteins
6) PDA Technical Report No. 39, Revised 2007, Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation
7) PDA Technical Report No. 33, Evaluation, Validation and Implementation of New Microbiological Testing Methods
8) PDA Technical Report No. 13 Revised, Fundamentals of an Environmental Monitoring Program - 30% Off
9) PDA Technical Report No. 27 Pharmaceutical Package Integrity - 30% Off
10) PDA Technical Report No. 36, Current Practices in the Validation of Aseptic Processing - 2001
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PDA Technical Reports cover a wide variety of subjects relating to pharmaceutical production, validation and quality assurance. These global consensus documents are prepared by member-driven Task Forces comprised of content experts including industry, regulatory and academic scientists and engineers. This level of expertise ensures a broad perspective reflecting best thinking and practices currently available.
Once the Task Force has produced a preliminary draft, it is vetted through a PDA technical review process. A web-based on-line review tool is available to facilitate comments. They may also be the subject of discussion at PDA technical forums, where they are discussed by a panel of experts and subjected to questioning by the audience. These forums have been extremely valuable in pointing out needed clarifications prior to publication.
Final drafts may be shared with other industry stakeholders such as the United States Pharmacopeia (USP), The Pharmaceutical Research and Manufacturers of America (PhRMA), and the US Food and Drug Administration (FDA), and with interested individuals upon request. Comments from these reviews are considered by the Task Force and incorporated into the PDA Draft Technical Report, where appropriate.
When the Task Force is convinced it has produced the best document possible, the draft is submitted to the PDA Science Advisory Board (SAB), Biotechnology Advisory Board (BioAB) or the PDA Regulatory Affairs and Quality Committee (RAQC), as appropriate, for review and balloting. Any substantive comments are incorporated into the report prior to publication.
Once approved by an Advisory Board, the Final draft is submitted for review and approval by the PDA's Board of Directors in order to go to publication.
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