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        Development & Approval Process | Drugs

Pharmaceutical Quality Resources

                        
                Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
          Search for Pharmaceutical Quality Documents
          Current Good Manufacturing Practice (CGMP) Regulations
          CDER Quality Management Maturity
          Q&A on CGMP Requirements
          Inspection | Enforcement Resources
          Questions and Answers on Quality-Related Controlled Correspondence Home
          Drugs
          Development & Approval Process | Drugs
          Pharmaceutical Quality ResourcesDevelopment & Approval Process | Drugs Pharmaceutical Quality Resources
  	
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    PrintPharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications.

The Center for Drug Evaluation and Research (CDER) 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 biological products, generics, biosimilars, over-the-counter drugs and certain compounded drugs.

The resources below offer information on pharmaceutical quality topics for manufacturers and applicants.
Sub-Topic Paragraphs
          ResourcesQuality Information for Applicants
            Chemistry, Manufacturing, and Controls information for NDAs, ANDAs, BLAs, and IND applicationsAdvancing Product Quality
            Efforts to encourage innovation in manufacturing processes and technologySearch for Pharmaceutical Quality Documents
            Improved access to FDA’s Office of Pharmaceutical Quality resources and web contentCurrent Good Manufacturing Practice (CGMP) Regulations
            Requirements for drug product manufacturing, processing, and packing.Contact for Further Information
            CDER-OPQ-Inquiries@fda.hhs.gov

                                                                                  Content current as of:
      12/22/2023
                  
                   
Regulated Product(s)
		 DrugsPharmaceutical Quality Resources                
                          

                        Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
          Search for Pharmaceutical Quality Documents
          Current Good Manufacturing Practice (CGMP) Regulations
          CDER Quality Management Maturity
          Q&A on CGMP Requirements
          Inspection | Enforcement Resources
          Questions and Answers on Quality-Related Controlled Correspondence
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