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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Maintains a Productive Publishing Year

Jan 03, 2017

PDA’s Board of Directors, advisory boards, technical report teams and Science and Regulatory staff produced four technical reports, a Points to Consider document, and three PDA surveys in 2016—continuing a streak of highly productive publishing years. This batch of varied and interesting publications included:

  • Technical Report No. 56 (Revised 2016): Application of Phase- Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance)
  • Technical Report No. 74: Reprocessing of Biopharmaceuticals
  • Technical Report No. 75: Consensus Method for Rating 0.1μ Mycoplasma Reduction Filters
  • Technical Report No. 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging
  • Points to Consider for Aseptic Processing, Part 2
  • PDA Survey: 2015 Aging Facilities
  • PDA Survey: 2015 Particulate Matter in Difficult to Inspect Parenterals
  • PDA Survey: 2015 Particulate Matter in Oral Dosage Forms

PDA technical reports go through the PDA peer review process, which includes a global review by subject matter experts, advisory board ballot, and Board of Directors (BOD) ballot. Both the advisory board ballot and BOD ballot can result in rejection of the document or changes to it. Surveys are produced as part of the development of a future document (usually a technical report)] but do not go through the peer review process. All PDA technical document projects are sanctioned, or approved, first by an advisory board (i.e., the Science, Biotechnology, or Regulatory Affairs and Quality Advisory Board). PDA also published two “PDA Papers” in the PDA Journal of Pharmaceutical Science and Technology. These are official position papers approved through the PDA peer review process.

Members can expect more of the same in 2017. The first technical report out this year will cover blow/fill/seal technology and will publish in January. Members can also look forward to other several other TRs covering important topics like glass handling, autologous cell therapy control strategies, and validation of protein manufacturing, along with more “PDA Papers” and surveys.

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