Drugs

Pharmaceutical Quality Resources

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.

Latest News:

  • OPQ issued a white paper describing key considerations for applicants when preparing a Quality Overall Summary (QOS). The QOS is a summary of all quality-related information provided by applicants to regulators in drug marketing or licensing applications, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs) in the United States.
  • Elemental Impurities: As of January 1, 2018, all new NDAs and ANDAs are required to meet applicable USP and ICH Q3D requirements regarding elemental impurities. Click here for more information.
As part of an application to make a drug applicants are expected to show that they can consistently produce a quality product.  The following resources are helpful in achieving this goal. They provide information relevant to various application types and may also be helpful for other types of products such as OTC monograph products:

The following resources provide additional details for specific types of applications:

In addition to our CGMP regulations, the following resources expand on FDA’s post-application expectations for manufacturers of drug substances and drug products.

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.
  • 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.

Contact for Further Information:

CDER-OPQ-Inquiries@fda.hhs.gov

 

Page Last Updated: 03/30/2018
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