USFDA Guidelines for Pharmaceuticals

United State Food and Drug Administration (USFDA) provides sterile and non-sterile pharmaceutical guidelines for industries. FDA updates guidelines time to time for inductries. All the FDA approved 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/Manufacturing Standards (CGMP)	Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 127KB)	Final Guidance	12/12/18
Compounding: Pharmaceutical Quality/Manufacturing Standards (CGMP)	Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF - 556KB)	Final Guidance	01/18/18
Compounding: Pharmaceutical Quality/Manufacturing Standards (CGMP)	Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF - 646KB)	Final Guidance	01/12/17
Compounding: Pharmaceutical Quality/Manufacturing Standards (CGMP)	Current Good Manufacturing Practice Requirements for Combination Products	Final Guidance	01/10/17
Compliance: Pharmaceutical Quality/Manufacturing Standards (CGMP)	Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB)	Final Guidance	11/22/16
Pharmaceutical Quality/CMC	Development and Submission of Near Infrared Analytical Procedures (PDF - 176KB)	Draft Guidance	03/30/15
Draft Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products	Current Good Manufacturing Practice Requirements for Combination Products	Draft Guidance	01/27/15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)	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 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

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