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# BLA Assessment Roles Clarified
- URL: https://www.fdaweb.com/bla-assessment-roles-clarified/
- Published: 2017-07-26T12:00:00.000Z
- Updated: 2026-09-14T22:36:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139228

CDER has issued a Manual of Policies and Procedures (MAPP) on the role of the Office of Biotechnology Products (OBP) and the Office of Process and Facilities (OPF) in assessing BLAs. The two offices are located within the Office of Pharmaceutical Quality. The MAPP says that OBP and OPF have implemented a process improvement initiative to improve coordination in the evaluation of applications. The initiative includes development of: 

- a timely and responsive system to ensure product quality throughout the product life cycle;
- a process that allows for efficiency, consistency, and innovation within the agency and in industry;
- the use of science-based risk management and quality principles; and
- an integrated (multi-disciplined) collaboration.

The MAPP was created to outline OBP and OPF responsibilities and procedures as part of the process improvement initiative, it says.

The joint responsibilities of OBP and OPF include **(1)** quality assessment of BLAs in accordance with discipline-specific areas of responsibilities; and **(2)** planning and conducting collaborative establishment inspections to ensure safety, purity, and potency of the product based on the firm’s compliance history, the process control strategy, and facility information.