Office of Pharmaceutical Manufacturing Assessment
Who We Are
The Office of Pharmaceutical Manufacturing Assessment (OPMA), part of CDER’s super Office of Pharmaceutical Quality, assures that quality pharmaceuticals are consistently manufactured over the product lifecycle.
What We Do
- Leads the assessment of manufacturing processes, facilities, and microbiological control for CDER’s application drug review program.
- Performs manufacturing assessments of New Drug Applications, Abbreviated New Drug Applications, and Biologic License Applications and as appropriate, post-approval supplements, investigational drug applications, emergency use authorizations, Drug Master Files and other intra-agency applications.
- Evaluates facilities, process design, and control strategies, and determines need for facility inspections to assess the capability of manufacturers to produce quality pharmaceutical and biotechnology products at commercial scale.
- Evaluates microbiological controls and assurance of sterility for sterile drug substances, excipients, and drug products and for non-sterile products, based on potential risks to quality and safety.
- Manages the pre-approval inspection (PAI), pre-license inspection (PLI), and product specific post-approval programs.
- Leads execution of PLI and participates as subject matter experts on PAIs and post approval inspections, as appropriate.
- Communicates with investigators, IQA team assessors and compliance teams, as appropriate, to collaboratively consider manufacturing process and facility related quality issues that may impact approval.
- Partners with other offices internal and external to Office of Pharmaceutical Quality to establish standards for OPMA assessment and inspectional activities, including novel and complex manufacturing technologies.
- Provides technical expertise to other Food and Drug Administration components regarding manufacturing quality issues.
These organizations report to the Office of Pharmaceutical Manufacturing Assessment:
- Division of Pharmaceutical Manufacturing Assessment I
- Division of Pharmaceutical Manufacturing Assessment II
- Division of Pharmaceutical Manufacturing Assessment III
- Division of Pharmaceutical Manufacturing Assessment IV
- Division of Microbiology Assessment I
- Division of Microbiology Assessment II
- Division of Biotechnology Manufacturing
- Office of Pharmaceutical Quality
- Pharmaceutical Quality Resources
- Office of Pharmaceutical Quality Reports
- Report on the State of Pharmaceutical Quality
- White Paper: FDA Pharmaceutical Quality Oversight