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                Pharmaceutical Quality Resources

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
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          Pharmaceutical Quality Resources
          Q&A on CGMP RequirementsPharmaceutical Quality Resources Q&A on CGMP Requirements
  
  	
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    PrintAs part of the Current Good Manufacturing Practice (CGMP) initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, we have developed this question and answer resource on current good manufacturing practice. We intend to use this format to provide timely answers to questions about the meaning and application of CGMP for human, animal, and biological drugs, and to share these widely. These questions and answers clarify statements of existing requirements or policy that are minor in nature, and as such, are considered Level 2 guidance. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2017-D-6821 (see the instructions for submitting comments in the docket). This resource is being cosponsored by CDER, CVM, CBER, and ORA. The Q&As generally clarify the existing CGMP regulations for finished pharmaceuticals: 21 CFR part 211

Questions and Answers on Specific Topics:

General Provisions
	Organization and Personnel
	Buildings and Facilities
	Equipment
	Control of Components and Drug Product Containers and Closures
	Production and Process Controls
	Packaging and Labeling Control
	Holding and Distribution
	Laboratory Controls
	Records and Reports
	Returned and Salvaged Drug Products**Contact for Further Information:**

CDER-OPQ-Inquiries@fda.hhs.gov

                                                                                  Content current as of:
      10/19/2023
              
              
Regulated Product(s)
		 DrugsTopic(s)
			  Pharmaceutical QualityPharmaceutical 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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