USFDA Guidelines for Pharmaceuticals : Pharmaceutical Guidelines

USFDA Guidelines for Pharmaceuticals

Current USFDA guidelines and latest updates including process validation, GMP compliance, FDA warning letters, 21 CFR, GLP, Stability Testing, Out of Specification etc.
United State Food and Drug Administration (USFDA) provides the sterile and non-sterile pharmaceutical guidelines for industries. FDA updates these guidelines time to time the provides to their users. All the FDA approves plants have to follow these FDA guidelines throughout the world.
FDA provides the pharmaceutical guidelines for all the stages from raw material to finished pharmaceutical products.

USFDA GMP Guidelines

Category
Title
Type
Date
Pharmaceutical Quality/CMC Development and Submission of Near Infrared Analytical Procedures (PDF - 176KB)
Draft Guidance
 03/30/15 
Draft Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products Current Good Manufacturing Practice Requirements for Combination Products
Draft
Guidance
 01/27/15 
Pharmaceutical Quality/CMC SUPAC: Manufacturing Equipment Addendum (PDF - 213KB)
Final Guidance
 12/01/14 
Pharmaceutical Quality/CMC ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers (PDF - 124KB)
Final Guidance
 05/14/14 
Current Good Manufacturing Practices (CGMPs)
Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 60KB)
Final Guidance
 06/25/13 
Current Good Manufacturing Practices (CGMPs)
Final Guidance
 04/17/13 
Current Good Manufacturing Practices (CGMPs) - Compliance 
Draft Guidance
 07/03/12 
Current Good Manufacturing (CGMP's) Compliance 
Final Guidance
06/28/12 
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
04/10/12
Current Good Manufacturing Practices (CGMP's) 
Draft Guidance
02/10/12
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
12/21/11
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
09/19/11
Current Good Manufacturing Practices/Compliance and Small Entity Compliance Guide 
Final Guidance
08/04/11 
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
05/04/11
Current Good Manufacturing Practices (CGMPs) 
Draft Guidance
03/14/11
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
01/24/11
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
01/26/10
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
12/09/09
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
08/06/09
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
07/14/08
Current Good Manufacturing Practices (CGMPs)/Compliance
Final Guidance
05/10/07
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
05/01/07
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
11/13/06
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
10/11/06
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
09/27/06
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
03/01/06
Current Good Manufacturing Practices (CGMPs)/Compliance
Final Guidance
01/11/06
Current Good Manufacturing Practices (CGMPs)/Compliance 
Draft Guidance
05/31/05
Current Good Manufacturing Practices (CGMPs)/Compliance 
Draft Guidance
10/04/04
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
09/29/04
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
09/29/04
Current Good Manufacturing Practices (CGMPs)/Compliance 
Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment (PDF - 244KB) 
Draft Guidance
11/07/03
Current Good Manufacturing Practices (CGMPs)/Compliance 
Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment: Revised Attachments (PDF - 157KB)
Draft Guidance
11/01/03
Current Good Manufacturing Practices (CGMPs)/Compliance and Chemistry, Manufacturing, and Controls (CMC)
Draft Guidance
09/05/03
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
09/03/03
Current Good Manufacturing Practices (CGMPs)/Compliance 
 Draft Guidance
05/06/03
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
05/01/02
Current Good Manufacturing Practices (CGMPs)/Compliance
Final Guidance
04/05/01
Current Good Manufacturing Practices (CGMPs)/Compliance
Draft Guidance
04/17/98
 Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
03/02/98
Current Good Manufacturing Practices (CGMPs)/Compliance 
Final Guidance
06/27/97

Following are some other USFDA guidelines links

Biological Products

Other Guidelines






Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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