PDA TR60 (Revised 2026): Advancing Process Validation Across the Lifecycle
A modern lifecycle approach to Process Validation
Process Validation (PV) is an essential element in the assurance of drug quality. PV is not a one-time event but an activity that spans the entire product lifecycle. The Parenteral Drug Association (PDA) has issued a revision of their Technical Report No. 60, originally published in 2013. The 2026 revision is a substantially expanded and modernized update that reflects evolutions in regulatory expectations, technology, statistical methods, and lifecycle thinking. It is fully structured around the 3-stage lifecycle model with comprehensive chapters on each lifecycle stage. The PV lifecycle is not linear, and changes can occur at any point as process knowledge evolves. The revision adds detailed chapters on PV enabling systems and technology, and structured knowledge management (including automation, software, analytics, trend analysis, continuous monitoring, and maintaining state of control). The 2026 revision supports digital maturity trends, encouraging adoption of technologies for efficiency and compliance (Pharma 4.0).
Strengthening Quality Risk Management and statistical rigor
The document has strong emphasis on Quality Risk Management (QRM) and science-based decisions that drive all stages (e.g. process design, process characterization, DoE use, Process Validation Master Plan, and programs for Continuous Process Verification). TR60 provides extensive statistical guidance to support the validation lifecycle process, including methods for determining number of lots that may be required at the PPQ stage, and recommended statistical process control charts.
Integrated CMC expertise to support the full lifecycle
Progress’ multidisciplinary approach integrates expertise in Process and Analytical Development, Production, QC, QA, and Regulatory Affairs – ensuring all CMC deliverables are aligned with scientific, technical and regulatory expectations. Our CMC experts support clients through the entire product lifecycle – from first-in-human trials to commercial scale-up and validation.
