PDA Technical Report No. 60-3 (TR 60-3) Process Validation: A Lifecycle Approach, Annex 2: Biopharmaceutical Drug Substances Manufacturing (single user digital version)

The concepts presented in PDA Technical Report No. 60-3 (TR 60-3): Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances Manufacturing 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 PDA 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 approaches are intended to add value, support good business practices, and meet current compliance and regulatory expectations.

This technical report focuses on the validation of biopharmaceutical processes used to manufacture therapeutic proteins, polypeptides, and vaccine drug substances. These drug substances are produced from recombinant or nonrecombinant cell-culture expression systems and can be characterized using appropriate analytical procedures. This information also applies to biosimilar products and chemically modified proteins, including pegylated proteins, antibody-drug conjugates, conjugated vaccines, and other conjugated proteins. Selected principles outlined in TR 60-3 may also apply to other product types, such as proteins and polypeptides isolated from tissues and body fluids, and plasma-derived products.

This technical report aims to provide clear technical guidance for the development and design of a process validation master plan using a risk-based lifecycle approach, and to provide a comprehensive overview of strategies that may be used to validate a manufacturing process or unit operations.

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