New Version of PDA Technical Report No. 60 on Process Validation Published
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The PDA Technical Report No. 60, Process Validation – A Life Cycle Approach, has been in existence since 2013. The document has now undergone extensive revisions. What has changed? The following is a summary of the changes.
The new 2026 version has grown from 102 pages in 2013 to 162 pages. Compared with the 2013 edition, its scope now includes not only the products covered previously, but also Advanced Therapy Medicinal Products (ATMPs), Regenerative Medicine Advanced Therapies (RMATs), and blood products. Human tissues are excluded, except when they form part of an ATMP.
A dedicated subsection provides information on the relevant guidelines published since 2013. Among others, it identifies the following as key documents:
- EU Annex 1, Annex 11, Annex 15 etc.
- FDA Data Integrity Q&A, Part 11
- ICH Q9 (R1), Q12, Q13, Q14
Against this background, the 2026 version places the process validation lifecycle more firmly within the context of current regulatory expectations, including lifecycle management, continuous manufacturing, the analytical lifecycle, and data integrity/computerised system validation.
The chapter on process development (Stage 1 of the process validation lifecycle) has been expanded. It now also addresses existing products and post-approval changes (“Post-Approval Change Management”). This creates a stronger link between process development, legacy products, and post-approval change management.
Interestingly, Stage 2 is now referred to as Performance Qualification. This differs from the 2013 version and the FDA Process Validation Guidance, both of which refer to this stage as Process Qualification. Process Performance Qualification (PPQ) is integrated into Performance Qualification, which is comparable to the FDA’s process validation guidance. Despite the revised terminology, the FDA’s three-stage model remains part of the document.
The chapter on Continued Process Verification (CPV), Stage 3 of the process validation lifecycle, contains significantly more digital and data-driven elements in the 2026 version. A new subsection on “Data Science” has therefore been added. Other new topics include data generation, data management, digital twins, and the use of artificial intelligence. Accordingly, CPV in the guideline addresses not only monitoring and trending, but also data-driven process control.
The 2026 version provides a more detailed description of how legacy products should be handled. For example, it addresses the integration of a legacy product into CPV. This is presented in a very practical “roadmap,” helping companies that wish to subsequently incorporate legacy products into their CPV programme.
Knowledge management is described in greater detail than in the 2013 version, including roles, responsibilities, and rights. The document also addresses knowledge management from a risk management perspective. In addition, it contains a dedicated subsection on the use of knowledge management in process validation. Knowledge management is therefore addressed in a more “systemic” manner than in the 2013 version.
The document is available for purchase on the PDA website.
Conclusion: With the revision of PDA Technical Report No. 60 on process validation, the document is once again up to date.
One of the authors involved in revising Technical Report No. 60 will lead an ECA Live Online Training on trending as part of Continued/Ongoing Process Verification from 14 to 16 October 2026.
