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:

• Quality Overall Summary (QOS): White Paper (PDF - 461 KB)
• CGMP Regulations
• Quality Related Guidances go to Search for FDA Guidance Documents and filter by
  • FDA Organization - Center for Drug Evaluation and Research and
  • Topic
    • ICH-Quality
    • Chemistry, Manufacturing, and Controls (CMC)
    • Microbiology 
    • Current Good Manufacturing Practice (CGMP)  
• Drug Master Files (DMFs)
• Inactive Ingredient Database
• Elemental Impurities

• Expiration Dates - Questions and Answers

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

• Investigational New Drug (IND) Applications for Clinical Investigations: CMC Information
• Current Good Manufacturing Practices for Phase I Investigational Drugs
• Generic Drugs: Information for Industry
  • Generic Drug User Fee Amendments (GDUFA II) Implementation

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

• CGMP related guidance (i.e. operating a drug manufacturing facility to acceptable standards on an ongoing basis) go to Search for FDA Guidance Documents and filter by
  • FDA Organization - Center for Drug Evaluation and Research and
  • Topic
    • ICH-Quality
    • Current Good Manufacturing Practice (CGMP)
• 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 an FDA funded research contract, Dun & Bradstreet (D&B) is partnering with the University of St.Gallen in Switzerland to conduct research to benchmark pharmaceutical quality management systems. The Quality Benchmarking Study (QBS) will produce a globally representative baseline data set that characterizes quality management among human drug manufacturers.
• 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.