About FDA

Office of Pharmaceutical Quality

CDER’s Office of Pharmaceutical Quality’s (OPQ) mission is to assure that quality medicines are available for the American public.

What OPQ Does

OPQ is a new office within CDER that creates a single unit dedicated to product quality.  The new structure, which stood-up in January 2015, provides better alignment among all drug quality functions at CDER, including review, inspection, and research.

OPQ combines non-enforcement-related drug quality work into one super-office, creating one quality voice and improving our oversight of quality throughout the lifecycle of a drug product. OPQ creates a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas – new drugs, generic drugs, and over-the-counter drugs.

This organizational structure, along with new processes and policies, supports our mission to ensure that safe, effective, high quality drugs are available for the American public.

The changes that established OPQ include the following offices:

Office of Pharmaceutical Quality Offices and Leadership

The following individuals serve as office leaders:

Director: Michael Kopcha, Ph.D., R.Ph.
Deputy Director: Lawrence Yu, Ph.D.

  • Office of Program and Regulatory Operations (OPRO): Director: Director: Giuseppe Randazzo
  • Office of Policy for Pharmaceutical Quality (OPPQ): Director: Ashley Boam
  • Office of Biotechnology Products (OBP): Director: Steve Kozlowski
  • Office of New Drug Products (ONDP): Director: Sarah Pope Miksinski
  • Office of Lifecycle Drug Products (OLDP): Director: Susan Rosencrance
  • Office of Testing and Research (OTR): Director: Lucinda (Cindy) Buhse
  • Office of Process and Facilities (OPF): Director: Robert Iser
  • Office of Surveillance (OS): Director: Sarah Pope Miksinski (Acting)

In addition to these offices, OPQ also has an Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical manufacturing.

OPQ Guidances on the FDA Website

CategoryTitleTypeDate
Procedural Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF - 226KB) Draft Guidance 04/24/17
Electronic Submissions Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 112KB) Final Guidance 04/07/17
Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) Final Guidance 11/22/16
Pharmaceutical Quality - CMC Regulatory Classification of Pharmaceutical Co-Crystals- Draft (PDF - 82KB) Draft Guidance 08/16/16
Pharmaceutical Quality/CMC Elemental Impurities in Drug Products (PDF - 100KB) Draft Guidance 06/30/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Technical Specifications Document: "Quality Metrics Technical Conformance Guide, Version 1.0“ has published (PDF - 114KB) Draft Guidance 06/24/16
Pharmaceutical Quality/CMC Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 121KB) Draft Guidance 06/16/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 120KB) Draft Guidance 04/14/16
Pharmaceutical Quality/CMC Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (PDF - 230KB) Draft Guidance 04/22/16
Pharmaceutical Quality/CMC Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry (PDF - 200KB) Draft Guidance 04/19/16
Pharmaceutical Quality/CMC Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (PDF - 136KB) Final Guidance 02/18/16
Generics/User Fees/ Pharmaceutical Quality/CMC Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 432KB) Final Guidance 02/12/16
Pharmaceutical Quality/CMC Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base; Draft Guidance for Industry; Availability (PDF - 63KB) Draft Guidance 12/23/15
Pharmaceutical Quality/CMC Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 146KB) Draft Guidance 10/29/15
Pharmaceutical Quality/CMC Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF - 113KB) Draft Guidance 10/21/15
Pharmaceutical Quality/CMC Botanical Drug Development: Guidance for Industry (PDF - 221KB) Final Guidance 12/28/16
Biopharmaceuticals Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs Guidance for Industry (PDF - 87KB) Draft Guidance 07/31/15
Pharmaceutical Quality/CMC and Pharmaceutical Quality/CGMP Submission of Quality Metrics Data Guidance for Industry (PDF - 340KB) Draft Guidance 11/23/16
Pharmaceutical Quality/CMC Analytical Procedures and Methods Validation for Drugs and Biologics (PDF - 134KB) Final Guidance 07/24/15
Pharmaceutical Quality/CMC Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products (PDF - 77KB) Final Guidance 06/24/15
Pharmaceutical Quality/CMC Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules (PDF - 89KB) Final Guidance 06/18/15
Labeling Naming of Drug Products Containing Salt Drug Substances (PDF - 210KB) Final Guidance 06/16/15
Pharmaceutical Quality/CMC Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry (PDF - 165KB) Draft Guidance 05/29/15
Biopharmaceutics Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. (PDF - 141KB) Draft Guidance 05/05/15
Pharmaceutical Quality/CMC Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (PDF - 69KB) Final Guidance 03/04/16
Pharmaceutical Quality/CMC Development and Submission of Near Infrared Analytical Procedures (PDF - 176KB) Draft Guidance 03/30/15

Page Last Updated: 05/10/2017
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