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  1. Center for Drug Evaluation and Research | CDER

Office of Policy for Pharmaceutical Quality

Who We Are

The Office of Policy for Pharmaceutical Quality (OPPQ) is responsible for developing and clearly communicating science and risk-based policies and standards related to drug product quality, including application review and inspection.

What We Do

  • Develops, implements, and updates science-and risk-based policies, related to the assessment of drug components and drug product (including drug-containing combination products) for human use. Pharmaceutical quality policies include those governing the standards and assessments in the Chemistry, Manufacturing and Controls section of applications for marketing approval and related submissions, and Current Good Manufacturing Practices. Evaluates the Food and Drug Administration's (FDA's) findings such as deficiencies and inspectional citations for conformance to established regulations, policies, and standards.
  • Leads and coordinates development of regulations, guidance documents, standards, Compliance Programs, and Manual of Policies and Procedures (MAPPs) with various business partners (e.g., Office of Pharmaceutical Quality (OPQ) sub-offices, Office of Compliance, other Center for Drug Evaluation and Research (CDER) offices and the Office of Regulatory Affairs) that address drug quality assessment from application review through market availability for all human drugs (human drugs include brand name drugs, generic drugs, biotechnology drugs, prescription drugs, over-the-counter products). Ensures that assessments are based on a thorough understanding of the product, process, dosage form, and clinically-relevant risk factors, and that regulatory policies and standards incorporate benefit-risk considerations.
  • Provides executive leadership of the CDER Council of Pharmaceutical Quality. Develops strategic product quality plans and initiates policy projects, with input from Council members, to address specific unmet needs. Collaborates with the FDA Council of Pharmaceutical Quality to address emerging drug product quality trends and establish strategic policy objectives in cooperation with OPQ.
  • Coordinates product quality outreach to and external communications to and from all stakeholders (Government Accountability Office, Congress, public, industry, and other domestic and foreign government agencies) to ensure consistent interpretation and application of CDER’s pharmaceutical quality policies and programs.
  • Collaborates with OPQ laboratories and helps prioritize research to support policy development and regulatory decision-making. Ensures that the research and scientific knowledge is identified, developed, if necessary, and appropriately used in policy development.
  • Coordinates OPQ engagement with national (e.g., Consumer Product Safety Commission, Department of Defense, National Institute of Standards and Technology) and internal regulatory authorities (e.g., International Council for Harmonization, Pharmaceutical Inspection Cooperation Scheme, World Health Organization) to ensure harmonization or convergence of policies and procedures for the efficient and effective regulation of pharmaceutical quality. Leads OPQ efforts to identify and develop strategic partnerships and information sharing arrangements with other government agencies, foreign and domestic, related to pharmaceutical quality.

Office Organization

The Office of Policy for Pharmaceutical Quality includes the following organizations: 

  • Editorial & Project Management Staff
  • Compendial Operations & Standards Staff
  • Division of Regulations, Guidance, & Standards
  • Division of Internal Policies & Programs

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