Most recent
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.
Content Provider
Parenteral Drug Association [pda]
