WHO WE ARE:
The Office of Pharmaceutical Manufacturing Assessment (OPMA) 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 assessement 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
Director: Dr. Stelios Tsinontides
Deputy Director: Vacant
Resources For You:
- Office of Pharmaceutical Quality
- OPQ Annual Report, 2019
- Report on the State of Pharmaceutical Quality, 2019 (PDF - 793K
- Pharmaceutical Quality Resources
- White Paper: FDA Pharmaceutical Quality Oversight (PDF - 2.4MB)
- Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations