Pharma Tips

USFDA Guidelines for Pharmaceuticals

By: Pharma Tips | Views: 6899 | Date: 19-May-2015

Current FDA guidelines, FDA process validation guideline, FDA GMP guidance, FDA warning letter, FDA 21 CFR, good manufacturing practices, FDA validation, Good Laboratory Practice Regulations, Expiration Dating and Stability Testing, FDA guide for sterile products, Out of Specification.

USFDA Guidelines for Pharmaceuticals

Current FDA guidelines, FDA process validation guideline, FDA GMP guidance, FDA warning letter, FDA 21 CFR, good manufacturing practices, FDA validation, Good Laboratory Practice Regulations, Expiration Dating and Stability Testing, FDA guide for sterile products, Out of Specification.



 

United State Food and Drug Administration (USFDA) provides the sterile and non sterile pharmaceutical guidelines for industries. USFDA updates these guidelines time to time the provides to their users. All the USFDA approves plants have to follow these guidelines throughout the world.
USFDA provides the pharmaceutical guidelines for all the stages from raw material to finished pharmaceutical products.
USFDA GMP Guidelines:

Category
Title
Type
Date
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Draft Guidance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Draft Guidance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Draft Guidance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

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