Office of Pharmaceutical Science (OPS)

Helen N. Winkle, Director
Keith O. Webber, Ph.D. Deputy Director

Who We Are: 
OPS Organization Chart (PDF - 23KB)

The Office of Pharmaceutical Science (OPS) is an umbrella organization over the activities of chemistry manufacturing and controls (CMC) review in CDER. This includes assessment of product and process design, evaluation of product quality in light of established standards and setting and maintaining new quality standards.

OPS is an integral part of CDER's new and generic drug product application review process. Staff working in these groups have backgrounds in chemistry, biology, biopharmaceutics, clinical pharmacology, immunology, pharmaceutical science, microbiology, pharmacology/toxicology and labeling.

The goal of OPS is to help establish common approaches to the manufacture and formulation of drugs among pharmaceutical manufacturers. OPS contributes to assuring the quality of drug products by providing uniform policies and review processes for the entire pharmaceutical industry through:

• Office of Generic Drugs
• Office of New Drug Quality Assessment
• Office of Biotechnology Products
• Office of Testing and Research
• Immediate Office Staff
  • Informatics and Computational Safety Analysis Staff (ICSAS)

OPS engages in scientific research to support decision making for application review, standard setting and for technology development.

Initiatives:

• OPS Coordinating Committee
• Quality Management Plan for the Chemistry Manufacturing and Controls Review Process (QMP for CMC Review) (PDF- 487KB)

  The CMC review process has adopted a Quality Management System (QMS) that will be governed by a Quality Management Plan (QMP).  The QMP presents the Quality System for the Chemistry Manufacturing and Controls (CMC) review process.  This Quality System is based on internal activities and intended to improve consistency of CMC reviews.

• Standards Activity
  • The Pharmaceutical Quality Standards Working Group (PQSWG)

    The PQSWG is established by The FDA Council for Pharmaceutical Quality (CPQ)  to coordinate and advise pharmaceutical programs in the development and recognition of standards, commensurate with the mission of the Agency, as outlined in  Staff Manual Guide 9100.1.
    PQSWG Charter

  • Compendium Standards (USP-NF)

    OPS provides consensus opinions on compendial standards for pharmaceutical articles, as established in the USP and NF and represents the position of the agency to USP in view of drug approval standards and all other applicable policies, regulations, and best practices.

• Process Analytical Technology (PAT)
• Environmental Assessment (EA)

  Under the National Environmental Policy Act of 1969 (NEPA), all Federal agencies are required to assess the environmental impact of their actions and to ensure that the interested and affected public is informed of the environmental analyses.  In CDER, adherence to NEPA is demonstrated by the EA portion of the drug application

• Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS-CP)

  The ACPS-CP Committee provides advice on scientific and technical issues concerning the safety, and effectiveness of drug products for human use and any other product for which the FDA has regulatory responsibility.
  The Committee Charter
  The Committee Roster
  Archived Meeting Files

• International Conference on Harmonisation (ICH)
• Pharmaceutical Inspectorate Detail Rotation
• Product Quality Research Institute (PQRI)
• Other OPS Initiatives

Director's Corner

Presentations on OPS missions and initiatives are compiled.

• OPS Program Updates (PDF - 188KB) 
• Implementing Quality by Design (PDF - 171KB)
• Regulatory Modernization (PDF - 137KB)

Events

Interactive Forum between FDA and Generic Industry (PDF - 332KB)

The forum will provide tools to have effective communication between FDA and industry.  Industry will learn of common deficiencies in abbreviated new drug applications (ANDA) and impacts of recently passed laws on FDA decisions.     

Regulatory Information

• Compilation of Laws and Related Statutes Enforced by FDA
• Acetonitrile Shortages: Recommendations for Reporting Changes in Analytical Procedures (PDF - 25KB)
• CDER Manual of Policies and Procedures
• ICH Q3A/Q3B Q&A (PDF - 11KB)
• Research Acquisitions (PDF - 26KB)
• QbD Publications (PDF - 75KB)

How to Contact Us
We ask you to take time to communicate with CDER about this web site.  What information is and isn't useful to you? Are there any additional items or categories of information you would like us to add? Please e-mail Jon Clark, jon.clark@fda.hhs.gov  with feedback about this site.