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.

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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)
Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework (PDF - 70KB)
Final Guidance
 04/17/13 
Current Good Manufacturing Practices (CGMPs) - Compliance 
Guidance for Industry: Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Labeling
Draft Guidance
 07/03/12 
Current Good Manufacturing (CGMP's) Compliance 
Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers
Final Guidance
06/28/12 
Current Good Manufacturing Practices (CGMPs)/Compliance 
Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PDF - 156KB)
Final Guidance
04/10/12
Current Good Manufacturing Practices (CGMP's) 
Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 175KB)
Draft Guidance
02/10/12
Current Good Manufacturing Practices (CGMPs)/Compliance 
Questions and Answers on Current Good Manufacturing Practices (CGMP) for Drugs
Final Guidance
12/21/11
Current Good Manufacturing Practices (CGMPs)/Compliance 
Marketed Unapproved Drugs -- Compliance Policy Guide (PDF   - 164KB) 
Final Guidance
09/19/11
Current Good Manufacturing Practices/Compliance and Small Entity Compliance Guide 
PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (PDF - 229KB)
Final Guidance
08/04/11 
Current Good Manufacturing Practices (CGMPs)/Compliance 
Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (PDF - 595KB)
Final Guidance
05/04/11
Current Good Manufacturing Practices (CGMPs) 
Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework (PDF - 116KB)
Draft Guidance
03/14/11
Current Good Manufacturing Practices (CGMPs)/Compliance 
Process Validation: General Principles and Practices (PDF - 372KB)
Final Guidance
01/24/11
Current Good Manufacturing Practices (CGMPs)/Compliance 
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) (PDF - 127KB) 
Final Guidance
01/26/10
Current Good Manufacturing Practices (CGMPs)/Compliance 
PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399KB)
Final Guidance
12/09/09
Current Good Manufacturing Practices (CGMPs)/Compliance 
Pharmaceutical Components at Risk for Melamine Contamination (PDF - 137KB)
Final Guidance
08/06/09
Current Good Manufacturing Practices (CGMPs)/Compliance 
Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 92KB)
Final Guidance
07/14/08
Current Good Manufacturing Practices (CGMPs)/Compliance
Computerized Systems Used in Clinical Trials (PDF - 53KB)
Final Guidance
05/10/07
Current Good Manufacturing Practices (CGMPs)/Compliance 
Testing of Glycerin for Diethylene Glycol (PDF - 36KB)
Final Guidance
05/01/07
Current Good Manufacturing Practices (CGMPs)/Compliance 
Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (PDF - 112KB)
Final Guidance
11/13/06
Current Good Manufacturing Practices (CGMPs)/Compliance 
Investigating Out-of-Specification Test Results for Pharmaceutical Production (PDF - 86KB) 
Final Guidance
10/11/06
Current Good Manufacturing Practices (CGMPs)/Compliance 
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 363KB)
Final Guidance
09/27/06
Current Good Manufacturing Practices (CGMPs)/Compliance 
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics (PDF - 38KB) 
Final Guidance
03/01/06
Current Good Manufacturing Practices (CGMPs)/Compliance
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA (PDF - 66KB)
Final Guidance
01/11/06
Current Good Manufacturing Practices (CGMPs)/Compliance 
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 31KB)
Draft Guidance
05/31/05
Current Good Manufacturing Practices (CGMPs)/Compliance 
Current Good Manufacturing Practice for Combination Products (PDF - 200KB) 
Draft Guidance
10/04/04
Current Good Manufacturing Practices (CGMPs)/Compliance 
PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 211KB) 
Final Guidance
09/29/04
Current Good Manufacturing Practices (CGMPs)/Compliance 
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF - 734KB)
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)
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 125KB) 
Draft Guidance
09/05/03
Current Good Manufacturing Practices (CGMPs)/Compliance 
Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF - 214KB)
Final Guidance
09/03/03
Current Good Manufacturing Practices (CGMPs)/Compliance 
 Current Good Manufacturing Practice for Medical Gases (PDF - 327KB)
 Draft Guidance
05/06/03
Current Good Manufacturing Practices (CGMPs)/Compliance 
Pharmacy Compounding -- Compliance Policy Guide (PDF - 659KB) 
Final Guidance
05/01/02
Current Good Manufacturing Practices (CGMPs)/Compliance
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory (PDF - 19KB)
Final Guidance
04/05/01
Current Good Manufacturing Practices (CGMPs)/Compliance
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB)
Draft Guidance
04/17/98
 Current Good Manufacturing Practices (CGMPs)/Compliance 
Good Laboratory Practice Regulations Questions and Answers (PDF - 2.2MB) 
Final Guidance
03/02/98
Current Good Manufacturing Practices (CGMPs)/Compliance 
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (PDF - 89KB) 
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
Newly Added Guidance Documents of Food
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
FDA guide for QS for cGMP
FDA Guide for Nonsterile Semisolid Dosage Forms
FDA guide for mfg sterile products
Also Read:
ICH Guidelines
MHRA-UK Guidelines
MCC Guidelines -South Africa
TGA Guidelines-Australia
MCA Guidelines-Zimbabwe
Schedule M-India




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