These revised reports address two critical aspects of modern drug manufacturing and reflect current regulatory expectations and real world industry experience to help manufacturers achieve consistent, compliant, and high quality outcomes. Technical Report No. 60 (Revised 2026): Process Validation: A Lifecycle Approach is a useful reference for the industry's continued focus on process validation, manufacturing reliability, and product quality. Technical Report No. 74 (Revised 2026): Reprocessing and Reworking of Biologicals provides guidance on the design, development, controls, procedures, validation, regulatory submission, and implementation of reprocessing and reworking procedures for the manufacturing of biologicals.
BETHESDA, Md., May 1, 2026 /PRNewswire-±¬ÁϹ«Éçapp/ -- The Parenteral Drug Association (PDA) today announced the release of and Technical Report , reinforcing PDA's ongoing commitment to providing the pharmaceutical industry with practical, science‑based guidance that supports manufacturing reliability, regulatory compliance, and product quality. Together, these revised reports address two critical aspects of modern drug manufacturing and reflect current regulatory expectations and real‑world industry experience to help manufacturers achieve consistent, compliant, and high‑quality outcomes.
Technical Report No. 60 (Revised 2026): Process Validation: A Lifecycle Approach is a useful reference for the industry's continued focus on process validation, manufacturing reliability, and product quality. Process validation is the collection and evaluation of data that establishes scientific evidence that a process is capable of consistently delivering quality products. The U.S. FDA and the European Medicines Association view process validation as an essential element drug manufacturing and include it in their current good manufacturing practice (GMP) guidelines.
"Technical Report No. 60 (Revised 2026) provides updated guidance to support a lifecycle approach to process validation that aligns with current regulatory expectations," said Joshua Eaton, Sr. Director, Scientific and Regulatory Affairs, PDA. "The report reflects industry experience and regulatory thinking on establishing and maintaining processes capable of consistently delivering quality products. PDA appreciates the efforts of the authoring team and the leadership of the Co‑Chairs—Robert Dream of HDR Company, LLC; Mauro Giusti of Eli Lilly & Co.; and Igor Gorsky of ValSource, Inc.—in producing this important resource."
Technical Report No. 74 (Revised 2026): Reprocessing and Reworking of Biologicals provides guidance on the design, development, controls, procedures, validation, regulatory submission, and implementation of reprocessing and reworking procedures for the manufacturing of biologicals. The information discussed represents what the authors consider to be a balance of scientific, regulatory, and business considerations for the reprocessing of biologicals but is applicable to the reworking of biologicals in general. It is highly recommended that manufacturers consult with the appropriate regulatory authority for agreement on the strategies employed for any biological reprocessing or reworking operation.
"The revised Technical Report No. 74 provides a practical, risk‑based framework for evaluating and implementing reprocessing and reworking activities for biological products," said Eaton. "The guidance integrates scientific, regulatory, and operational considerations and is intended to help manufacturers assess when reprocessing or rework is appropriate, while maintaining product quality and regulatory compliance. PDA thanks the authoring team and the Co‑Leads—Durga Prasad Madhavapeddi of FUJIFILM Diosynth Biotechnologies and Dilip Ayyala Somayajula of Revolution Medicines—for their leadership in developing this guidance."
These documents reflect PDA's ongoing dedication to providing the pharmaceutical industry with high-quality, practical resources that promote excellence in sterile product manufacturing.
About PDA
The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information. PDA creates awareness and understanding of important issues facing the pharma community and delivers high-quality, relevant education to the industry. Since its founding in 1946 as a nonprofit organization, PDA has been committed to developing scientifically sound, practical technical information and expertise to advance pharma manufacturing science and regulation, so members can better serve patients.
Media Contact
Walter Morris, www.pda.org, 1 3016565900, [email protected],
SOURCE Parenteral Drug Association (PDA)
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