Technical Reports

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. 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.

Working 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 Final Draft, it 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.

Some recent examples of Techncal Reports sponsored by or relevant to BioAB interests include:

PDA Technical Report No. 50 Alternative Methods for Mycoplasma Testing
Using alternative methodology for the detection of mycoplasma requires validation and demonstration of comparability to reference standards. 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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PDA Technical Report No. 49 Points to Consider for Biotechnology Cleaning Validation
Points to Consider for Biotechnology Cleaning Validation 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. 47: Preparation of Virus Spikes Used for Virus Clearance Studies
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. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications
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. 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. 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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