U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Office of Pharmaceutical Manufacturing Assessment
  1. Drugs

Office of Pharmaceutical Manufacturing Assessment

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.

Office Organization:
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 Leadership:                              
Director:  Dr. Stelios Tsinontides
Deputy Director:  Vacant

Resources For You:

 

Back to Top