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PDA TR 60-3-2021
Process Validation: A Lifecycle Approach - Annex 2: Biopharmaceutical Drug Substances Manufacturing
The concepts presented in TR-60-3 are intended to assist in the design and implementation of globally compliant validation programs to ensure process reproducibility and robustness as they relate to biotechnology-derived, purified protein drug substances. These models are based on the material and practices established in TR-60 and global regulatory guidances. Points to consider are provided to facilitate the collection of data in support of a regulatory filing for the approval of a biopharmaceutical drug substance intended to be used in a pharmaceutical product. The science-based practices provided here are grounded in the experiences of a PDA task force comprising a cross-section of industry professionals and experts in the field. The approaches are intended to add value, support good business practices, and meet current compliance and regulatory expectations.
Parenteral Drug Association [pda]