Plain-language explanations of key 21 CFR (drug, device and food), EU GMP, ICH and USP references, with inspection context and common violation patterns. Free and always growing.
Donor Eligibility
Current Good Tissue Practice for Human Cells, Tissues, and Cellular and Tissue-Based Products
Prescription Drug Labeling Exemption
Specific Requirements for Prescription Drug Labeling Content and Format
Status of Current Good Manufacturing Practice Regulations
Definitions
Scope of 21 CFR Part 211
Written Procedures - Establishment and Adherence
Production and Process Control Deviations
Charge-in of Components
Calculation of Yield
Equipment Identification
Sampling and Testing of In-Process Materials and Drug Products
Time Limits on Production
Control of Microbiological Contamination
Reprocessing
Labeling Issuance and Control
Labeling Reconciliation
Packaging and Label Operations
Tamper-Evident Packaging Requirements for OTC Human Drug Products
Drug Product Inspection
Expiration Dating
Warehousing Procedures
Distribution Procedures
Laboratory Controls - General Requirements
Laboratory Controls - Scientifically Sound Specifications and Methods
Testing and Release for Distribution
Stability Testing
Special Testing Requirements
Reserve Samples
Laboratory Animals
Penicillin Contamination
General Requirements - Records Retention and Annual Review
Annual Product Review
Equipment Cleaning and Use Log
Component, Container, Closure and Labeling Records
Master Production and Control Records
Batch Production and Control Records
Production Record Review - Investigation of Discrepancies and Failures
Laboratory Records
Distribution Records
Complaint Files
Returned Drug Products
Drug Product Salvaging
Quality Control Unit - General Authority
Quality Control Unit Responsibilities and Independence
Personnel Qualifications
Personnel Responsibilities - Gowning and Health
Consultants
Design and Construction Features of Buildings and Facilities
Lighting
Ventilation, Air Filtration, Air Heating and Cooling
Plumbing
Plumbing
Washing and Toilet Facilities
Sanitation
Maintenance
Equipment Design, Size and Location
Equipment Construction - Contact Surfaces
Equipment Cleaning and Maintenance
Automatic, Mechanical and Electronic Equipment
Filters
General Requirements - Component and Container Receipt
Receipt and Storage of Untested Components
Testing and Approval or Rejection of Components
Retesting of Approved Components, Containers and Closures
Rejected Components, Containers and Closures
Drug Product Containers and Closures
IND Content and Format
IND Safety Reporting
General Responsibilities of Sponsors
General Responsibilities of Investigators
Investigator Recordkeeping and Record Retention
Investigator Reports
Assurance of IRB Review
Content and Format of an NDA
Supplements and Other Changes to an Approved Application
Postmarketing Reporting of Adverse Drug Experiences
Field Alert Report Requirements
Annual Reports
Content and Format of an Abbreviated Application
Elements of Informed Consent
Personnel - Biological Products
Records - Biological Products
Reporting of Biological Product Deviations by Licensed Manufacturers
Postmarketing Reporting of Adverse Experiences
Changes to an Approved Biologics License Application
Biologics Licensing Procedures
Current Good Manufacturing Practice for Blood and Blood Components
Records - Blood and Blood Components
Sterility
General Safety, Purity and Potency - Constitution and Testing
Dating Periods for Biological Products
Biological Product Labeling
Corrective and Preventive Action (QMSR)
Device Labeling
Installation (QMSR)
General Requirements for Device Records
Device Master Record (QMSR)
Device History Record (QMSR)
Complaint Files (QMSR)
Management Responsibility (QMSR)
Servicing (QMSR)
Quality Audit (QMSR)
Statistical Techniques (QMSR)
Design Controls (QMSR)
Document Controls (QMSR)
Purchasing Controls (QMSR)
Identification
Traceability
Production and Process Controls
Inspection, Measuring and Test Equipment (QMSR)
Process Validation (QMSR)
Receiving, In-Process and Finished Device Acceptance
Nonconforming Product (QMSR)
Electronic Records and Electronic Signatures
Wholesale Drug Distributor Licensing Requirements
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Current Good Manufacturing Practice for PET Drugs
Investigational New Drug Application
Bioavailability and Bioequivalence Requirements
Regulation of Combination Products
Protection of Human Subjects
Financial Disclosure by Clinical Investigators
Institutional Review Boards
Good Laboratory Practice for Nonclinical Laboratory Studies
Enforcement Policy and Recalls
Medical Device Labeling
Medical Device Reporting
Establishment Registration and Device Listing
Drug Supply Chain Security Act
Prohibited Acts
Adulteration
Misbranding
Outsourcing Facilities
New Drug Approval
Abbreviated New Drug Applications
Drug Shortages Reporting
Registration of Producers
Device Classification
Factory Inspection Authority
Biologics Licensing
Biosimilars Licensure Pathway
Current Good Manufacturing Practice for Human Food
Supply-Chain Program
Personnel
Defect Action Levels
Food Safety Plan
Hazard Analysis
Preventive Controls
Recall Plan
Monitoring
Corrective Actions and Corrections
Validation of Preventive Controls
Verification of Implementation and Effectiveness
Reanalysis
Records Required for Subpart C
Requirements Applicable to a Preventive Controls Qualified Individual
Plant and Grounds
Modified Requirements That Apply to a Qualified Facility
Circumstances That May Lead FDA to Withdraw a Qualified Facility Exemption
Definitions
Sanitary Operations
Sanitary Facilities and Controls
Qualifications of Individuals Who Manufacture, Process, Pack or Hold Food
Equipment and Utensils
Exemptions
Applicability of Subparts C and G to a Facility Solely Engaged in the Storage of Unexposed Packaged Food
Processes and Controls
Warehousing and Distribution
Holding and Distribution of Human Food By-Products for Use as Animal Food
Registration of Food Facilities
Prior Notice of Imported Food
Establishment and Maintenance of Records
Foreign Supplier Verification Programs for Importers
Sanitary Transportation of Human and Animal Food
Additional Traceability Records for Certain Foods
Food Labeling
Foods for Special Dietary Use
Infant Formula Requirements: CGMP, Quality Control, Records and Reports
Emergency Permit Control
Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material
CGMP for Dietary Supplements
Standards for the Growing, Harvesting, Packing and Holding of Produce
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
Acidified Foods
CGMP, Hazard Analysis and Risk-Based Preventive Controls for Human Food
Production, Storage and Transportation of Shell Eggs
Hazard Analysis and Critical Control Point Systems for Juice
Mitigation Strategies to Protect Food Against Intentional Adulteration
Fish and Fishery Products (Seafood HACCP)
Processing and Bottling of Bottled Drinking Water
Milk and Cream
Cheeses and Related Cheese Products
Cereal Flours and Related Products
Eggs and Egg Products
Food Additives
Food Additives Permitted for Direct Addition to Food for Human Consumption
Secondary Direct Food Additives Permitted in Food for Human Consumption
Indirect Food Additives: Polymers
Substances Generally Recognized as Safe
CGMP, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Color Additives
Adulterated Food
Misbranded Food
Reportable Food Registry
Hazard Analysis and Risk-Based Preventive Controls
Mandatory Recall Authority
Food Supplements
Placing of Plant Protection Products on the Market
Food Enzymes
Food Additives
Flavourings and Certain Food Ingredients with Flavouring Properties
Identification and Registration of Bovine Animals and Labelling of Beef
General Food Law
Genetically Modified Food and Feed
Requirements for Feed Hygiene
Nutrition and Health Claims Made on Foods
Materials and Articles Intended to Come into Contact with Food
GMP for Materials and Articles Intended to Come into Contact with Food
Microbiological Criteria for Foodstuffs
Maximum Residue Levels of Pesticides in Food and Feed
Hygiene of Foodstuffs
Specific Hygiene Rules for Food of Animal Origin
Novel Foods
Official Controls Regulation
Organic Production and Labelling of Organic Products
Transparency and Sustainability of the EU Risk Assessment in the Food Chain
Maximum Levels for Certain Contaminants in Food
Plastic Materials and Articles Intended to Come into Contact with Food
Food Information to Consumers
Common Organisation of the Markets in Agricultural Products
Food for Specific Groups
Safety Features for Medicinal Products
Clinical Trials Regulation
GMP Principles and Guidelines for Medicinal Products for Human Use
Community Code Relating to Medicinal Products for Human Use
Falsified Medicines Directive
Good Distribution Practice
Good Distribution Practice of Active Substances
Pharmaceutical Quality System
Quality Risk Management
Premises
Personnel
Equipment
Production and Specific Technologies
Utilities
Environmental and Process Monitoring - Aseptic Processing
Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
Computerised Systems
Use of Ionising Radiation in the Manufacture of Medicinal Products
Investigational Medicinal Products
Manufacture of Products Derived from Human Blood or Plasma
Qualification and Validation
Certification by a Qualified Person and Batch Release
Real Time Release Testing and Parametric Release
Reference and Retention Samples
Manufacture of Biological Active Substances and Medicinal Products
Quality Risk Management
Importation of Medicinal Products
Artificial Intelligence in the Manufacture of Medicinal Products
Manufacture of Radiopharmaceuticals
Manufacture of Veterinary Medicinal Products
Manufacture of Medicinal Gases
Manufacture of Herbal Medicinal Products
Sampling of Starting and Packaging Materials
Manufacture of Liquids, Creams and Ointments
Pharmaceutical Quality System
Personnel
Premises and Equipment
Documentation
Production
Quality Control
Outsourced Activities
Complaints, Quality Defects and Product Recalls
Self Inspection
Basic Requirements for Active Substances Used as Starting Materials
Advanced Therapy Medicinal Products
Orphan Medicinal Products
Medicinal Products for Paediatric Use
Centralised Authorisation Procedure and the European Medicines Agency
Medical Device Regulation
Veterinary Medicinal Products
Variations to Marketing Authorisations
PIC/S Guide to Good Manufacturing Practice
Choice of Control Group in Clinical Trials
Clinical Investigation of Medicinal Products in the Pediatric Population
Clinical Evaluation of QT/QTc Interval Prolongation
Clinical Safety Data Management - Definitions and Standards for Expedited Reporting
Periodic Benefit-Risk Evaluation Report
Post-Approval Safety Data Management
Pharmacovigilance Planning
Structure and Content of Clinical Study Reports
Ethnic Factors in the Acceptability of Foreign Clinical Data
Good Clinical Practice
Studies in Support of Special Populations: Geriatrics
General Considerations for Clinical Studies
Estimands and Sensitivity Analysis in Clinical Trials
Bioanalytical Method Validation
Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Nonclinical Safety Studies for Clinical Trials and Marketing Authorization
The Common Technical Document
Common Technical Document - Efficacy
Common Technical Document - Quality
Common Technical Document - Safety
Assessment and Control of DNA Reactive (Mutagenic) Impurities
Biopharmaceutics Classification System-Based Biowaivers
Pharmaceutical Quality System
Development and Manufacture of Drug Substances
Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Continuous Manufacturing of Drug Substances and Drug Products
Analytical Procedure Development
Stability Testing of New Drug Substances and Products
Photostability Testing of New Drug Substances and Products
Stability Testing for New Dosage Forms
Bracketing and Matrixing Designs for Stability Testing
Evaluation of Stability Data
Validation of Analytical Procedures
Impurities in New Drug Substances
Impurities in New Drug Products
Residual Solvents
Elemental Impurities
Guideline for Extractables and Leachables
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Viral Safety Evaluation of Biotechnology Products
Analysis of the Expression Construct in Cells Used for Production
Quality of Biotechnological Products - Stability Testing
Derivation and Characterisation of Cell Substrates
Comparability of Biotechnological/Biological Products
Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products
Specifications for Biotechnological/Biological Products
Good Manufacturing Practice for Active Pharmaceutical Ingredients
Pharmaceutical Development
Quality Risk Management
Genotoxicity Testing and Data Interpretation for Pharmaceuticals
Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals
Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization
Nonclinical Evaluation for Anticancer Pharmaceuticals
Analytical Data, Interpretation and Treatment
Biological Assay Validation
Analytical Instrument Qualification
Good Manufacturing Practices for Bulk Pharmaceutical Excipients
Good Storage and Distribution Practices for Drug Products
Impurities in Drug Substances and Drug Products
The Dissolution Procedure - Development and Validation
Microbiological Examination of Nonsterile Products: Acceptance Criteria
Application of Water Activity Determination to Nonsterile Pharmaceutical Products
Microbial Characterization, Identification and Strain Typing
Microbiological Control and Monitoring of Aseptic Processing Environments
Microbiological Best Laboratory Practices
Near-Infrared Spectroscopy
Pharmaceutical Dosage Forms
Quality Assurance in Pharmaceutical Compounding
Package Integrity Evaluation - Sterile Products
Package Integrity Evaluation - Sterile Products
Statistical Tools for Procedure Validation
Sterilization and Sterility Assurance of Compendial Articles
Analytical Procedure Life Cycle
Validation of Alternative Microbiological Methods
Transfer of Analytical Procedures
Validation of Compendial Procedures
Verification of Compendial Procedures
Validation of Microbial Recovery from Pharmacopeial Articles
Depyrogenation
Sterilization of Compendial Articles
Water for Pharmaceutical Purposes
Weighing on an Analytical Balance
Pyrogen Test
Extractables and Leachables - Assessment Framework
Semisolid Drug Products - Performance Tests
Elemental Impurities - Limits and Procedures
Elastomeric Closures for Injections
Weights and Balances
Residual Solvents
Antimicrobial Effectiveness Testing
Microbiological Examination of Nonsterile Products - Microbial Enumeration Tests
Chromatography
Microbiological Examination of Nonsterile Products - Tests for Specified Microorganisms
Total Organic Carbon
Water Conductivity
Packaging and Storage Requirements
Plastic Packaging Systems and Their Materials of Construction
Containers - Performance Testing
Dissolution
Sterility Tests
Ophthalmic Products - Quality Tests
Osmolality and Osmolarity
Particulate Matter in Injections
Particulate Matter in Ophthalmic Solutions
Pharmaceutical Compounding - Sterile Preparations
Hazardous Drugs - Handling in Healthcare Settings
Positron Emission Tomography Drugs for Compounding, Investigational and Research Uses
Radiopharmaceuticals - Preparation, Compounding, Dispensing and Repackaging
Bacterial Endotoxins Test
Biological Reactivity Tests, In Vitro
Biological Reactivity Tests, In Vivo
Uniformity of Dosage Units
Water Determination
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