Recordkeeping CGMP for Finished Pharmaceuticals

Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)

OMB: 0910-0139

IC ID: 37604

Documents and Forms
Document Name
Document Type
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Information Collection (IC) Details

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Recordkeeping CGMP for Finished Pharmaceuticals CDER
 
No Unchanged
 
Mandatory
 
21 CFR 600 through 680 21 CFR 210; 211 21 CFR 225; 22 21 CFR 1271  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Public Health Monitoring

 

3,270 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 977,730 0 0 0 0 977,730
Annual IC Time Burden (Hours) 625,747 0 0 0 0 625,747
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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