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USFDA Guidelines for Pharmaceuticals


Current USFDA guidelines and latest updates including process validation, GMP, 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. 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
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Draft Guidance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Draft Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products Current Good Manufacturing Practice Requirements for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Draft
Guidance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Draft Guidance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Draft Guidance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Draft Guidance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 the some other USFDA guidelines links.

Process Validation New Guideline: General Principles and Practices
Finished Pharmaceuticals (human and animal products)
Current News & Events
FDA Information about guidance
Newly Added Guidance Documents of Drugs
Guidance Documents (Medical Devices and Radiation-Emitting Products)
21 CFR Parts 210 - Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; General
21 CFR 211 - Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; Current Good Manufacturing Practice For Finished Pharmeceuticals
21 CFR 58 - Good Labratory Practices for Non-Clinical Laboratory Studies
Biological Products

21 CFR 600 - Biologic Products: General
21 CFR 601 - Licensing
21 CFR 610 - General Biological Products Standards
Other Guidelines

PERSONNEL: TRAINING PROCEDURE
SAMPLING MANAGEMENT
ANALYST WORKSHEET
Sample Handling
Basic Statistics and Data Presentation
ASSURING THE QUALITY OF TEST RESULTS
ELEMENTAL ANALYSIS
REPORTING LABORATORY DATA
ESTIMATION OF UNCERTAINTY OF MEASUREMENT
METHOD DEVELOPMENT and VALIDATION PROGRAM
MEASUREMENT TRACEABILITY
METHODS, METHOD VERIFICATION AND VALIDATION
DRUG ANALYSIS
INSTRUMENT AND EQUIPMENT DOCUMENTATION AND RECORDS
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms
Investigating Out of Specification(OOS)
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS
FDA guide for powder blends
Modified Release Solid Oral Dosage Forms
FDA guide for QS for cGMP
FDA Guide for Nonsterile Semisolid Dosage Forms
FDA guide for mfg sterile products
Also Read:

ISO Guidelines
WHO Guidelines
ICH Guidelines
MHRA-UK Guidelines
MCC Guidelines -South Africa
TGA Guidelines-Australia
Schedule M-India

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. Email: .moc.enilediugamrahp@ofni



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