Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. CDER developed a Quality Initiative and established the Office of Pharmaceutical Quality (OPQ) to ensure a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all human drug product areas – new drugs and biologics, generics, and biosimilars—and also over-the-counter drugs and compounded drug products. This white paper provides additional background regarding OPQ and the FDA’s oversight of pharmaceutical quality.
Patients and consumers can learn more about quality and how Current Good Manufacturing Practices (CGMPs) impact them.
The resources below offer information on pharmaceutical quality topics for manufacturers and applicants.
- Feb 2019 – FDA published a draft guidance on quality considerations for continuous manufacturing.
- Dec 2018 - FDA posted Frequently Asked Questions regarding the Quality Metrics Feedback Program and 2018 Quality Metrics Site Visit Program.
- October 2018 – FDA published a final guidance on packaging terms for injectable products in multiple-dose, single-dose, and single-patient use containers
- September 2018 – The Agency posted a Manual of Policies and Procedures (MAPP) regarding our risk-based site selection model, as well as updates regarding GDUFA II commitments related to facilities
- September 2018 – FDA published a draft guidance on postapproval changes to drug substances
- Quality Overall Summary (QOS): White Paper (PDF - 461 KB)
- CGMP Regulations
- Quality Related Guidances
- Drug Master Files (DMFs)
- Inactive Ingredient Database
- Elemental Impurities
The following resources provide additional details for specific types of applications:
- The following contain lists of CGMP related guidance (i.e. operating a drug manufacturing facility to acceptable standards on an ongoing basis).
- Report a Product Quality Issue: Identify quality defects in distributed drug products that may present a potential safety threat
FDA is also engaged in efforts to foster innovations in manufacturing processes and technology and to foster a quality culture. This includes re-aligning FDA programs and surveillance activities to ensure efficient and effective regulatory oversight.
- Through our Emerging Technology Program, FDA meets with companies developing technologies that may offer significant improvements to pharmaceutical quality and provides recommendations to help support anticipated applications. The Emerging Technology Team has considered continuous manufacturing, 3D printing, and a variety of other technologies.
- FDA also continues to support other advanced manufacturing technologies, such as Process Analytical Technology.
- International Collaborations: FDA also engages foreign regulatory counterparts to coordinate on ways to advance product quality. For example, we work with the International Council on Harmonisation to develop harmonized quality standards and facilitate implementation by industry. FDA is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which is an international organization dedicated to harmonizing inspection practices and related policies. FDA has also engaged in initiatives such as the Mutual Recognition Agreement to utilize inspectional observations from capable regulatory authorities, reduce duplicative efforts, and focus resources and inspections on facilities that pose the greatest risk.
- In June 2017, CDER and ORA entered into a Concept of Operations to integrate facility evaluations and inspections for human drugs. See our Q&A page for additional details about how this collaboration will improve consistency, efficiency and transparency for facility evaluations and inspections.
- Quality metrics are used to monitor quality control systems and drive continuous improvement efforts. FDA’s quality metrics webpage provides background on the FDA’s efforts to initiate a voluntary reporting program so that key metrics can be provided to the FDA.
- Science and research pertaining to drug product quality remains the foundation that underlies sound regulatory decisions. OPQ established research Centers of Excellence to provide platforms for centralized, focused research collaboration and communication.
- Quality Metrics
Pharmaceutical Product Lifecycle
FDA’s Office of Pharmaceutical Quality (4/4/16): CDER SBIA Chronicles
New Drug Quality (9/17/12): CDER SBIA Chronicles