GMP Publications - Code of Federal Regulation Handbooks by the FDA

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US 21 Code of Federal Regulations (CFR)
    21 CFR Part 3 - Product Jurisdiction
    21 CFR Part 4 - Regulation of Combination Product
    21 CFR Part 7 - Enforcement Policy
    21 CFR Part 11 with Scope and Application
    21 CFR Part 11 - Preambles
    21 CFR Part 11 - Audit Checklist
    21 CFR Part 11 - Spanish Translation
    21 CFR Part 13 - Public Hearing
    21 CFR Part 16 - Regulatory hearing before the FDA
    21 CFR Part 50 - Protection of Human Subjects
    21 CFR Part 54 - Financial Disclosure by Clinical Investigators
    21 CFR Part 56 - Institutional Review Boards
    21 CFR Part 58 - Good Laboratory Practice
    21 CFR Part 101 - Food Labeling
    21 CFR Part 106 - Infant Formula Quality Control Procedures
    21 CFR Part 107 - Infant Formula
    21 CFR Part 108 - Emergency Permit Control
    21 CFR Part 110 - cGMP in Manufacturing Packing or Holding Human Food
    21 CFR Part 110 - Food GMPs - Spanish Translation
    21 CFR Part 111 - Dietary Supplement handbook
    21 CFR Part 112 - Produce for Human Consumption
    21 CFR Part 113 - Thermally Processed Low-Acid Foods
    21 CFR Part 114 - Acidified Foods
    21 CFR Part 115 - Shell Eggs
    21 CFR Part 117 - Food GMPs
    21 CFR Part 118 - Production Storage and Transportation of Shell Eggs
    21 CFR Part 120 - Hazard Analysis and Critical Control Point HACCP Systems
    21 CFR Part 123 - Fish and Fishery Products
    21 CFR Part 130 - Food standards - General
    21 CFR Part 131 - Milk and Cream
    21 CFR Part 133 - Cheeses and Related Cheese Products
    21 CFR Part 200 - General Drug
    21 CFR Part 201 - Drug Labeling
    21 CFR Part 203 - Prescription Drug Marketing
    21 CFR Part 205 - State Licensing of Wholesale Prescription Drug Distributors
    21 CFR Part 210 211 - Drug GMPs for Finished Pharmaceuticals
    21 CFR Part 210 211 - Spanish Translation
    21 CFR Part 210 211 - Drug Preambles
    21 CFR Part 210 211 - GMP Audit Check List
    21 CFR Part 210 211 - Keyword Index
    21 CFR Part 312 - Investigational New Drug Application
    21 CFR Part 314 - Applications for FDA Approval to Market a New Drug
    21 CFR Part 316 - Orphan Drugs
    21 CFR Part 320 - Bioavailability and Bioequivalence Requirements
    21 CFR Part 511 - New Animal Drugs For Investigational Use
    21 CFR Part 600 - Biological Products - General
    21 CFR Part 601 - Licensing - Biologics
    21 CFR Part 606 - cGMP for Blood and Blood Components
    21 CFR Part 607 - Estab Reg and Product Listing for Human Blood and Blood Products
    21 CFR Part 610 - General Biological Products Standards
    21 CFR Part 630 - Gen Requirements for Blood - Blood Components and Blood Derivatives
    21 CFR Part 640 - Additional Standards for Human Blood and Blood Products
    21 CFR Part 660 - Additional Standards for Diagnostic Substances for Laboratory Tests
    21 CFR Part 680 - Additional Standards for Miscellaneous Products
    21 CFR Part 700 - Cosmetic-General
    21 CFR Part 701 - Cosmetic-Labeling
    21 CFR Part 801 - Labeling - Medical Device
    21 CFR Part 803 - Medical Device Reporting
    21 CFR Part 806 - Medical Devices - Reports of Corrections and Removal
    21 CFR Part 807 - Estab. Reg. and Device Listing for Manuf and Initial Importers of Devices
    21 CFR Part 809 - In-Vitro Diagnostic Products
    21 CFR Part 810 - Medical Device Recall Authority
    21 CFR Part 812 - Investigational Device Exemptions
    21 CFR Part 814 - Premarket Approval of Medical Device
    21 CFR Part 820 - Quality System Regulations
    21 CFR Part 820 - Quality System Regulations (QSR) Audit Checklist
    21 CFR Part 820 - Quality System Regulations - Spanish Translation
    21 CFR Part 820 - Quality System Regulations - Chinese Translation
    21 CFR Part 821 - Medical Device Tracking Requirements
    21 CFR Part 822 - Post-market Surveillance
    21 CFR Part 830 - Unique Device Identification
    21 CFR Part 1270 - Human Tissue Intended for Transplantation
    21 CFR Part 1271 - Human Cells Tissues and Cellular and Tissue Based Products
   
US Other Federal Regulations 
  40 CFR 160 - Good Laboratory Practice Standards
    42 CFR 493 - Laboratory Requirements
    45 CFR 46 - Protection of Human Subjects
    45 CFR 160 - General Administrative Requirements
    45 CFR 162 - Administrative Requirements
   
US US Guidance Documents
  Pharmaceutical CGMPS for the 21st Century - A RISK-BASED APPROACH
  Computerized Systems Used in Clinical Investigations
  Guideline on General Principles of Process Validation
  Definition of a Combination Product
  Compliance Program Guidance Manual for FDA Staff
  Inspection of Medical Device Manufacturers Program 7382
  PAT - Framework for Innovative Pharma Development
  Sterile Drug Products Produced by Aseptic Processing - cGMP
  General Principles of Software Validation
  Quality Systems Approach to Pharmaceutical CGMP Regulations
  Medical Device QSIT Manual
  PMA Premarket Approval
  510k Guidelines
  Cosmetic - Is It Soap or a Drug
   
EU European Regulations
    EU GMPs - Chapters 1 - 9
    EU Annex 1 Manufacture of Sterile Medicinal Products
    EU Annex 2 Manufacture of Biological Medical Products for Human Use
    EU Annex 3 Manufacture of Radiopharmaceuticals
    EU Annex 4 Manufacture of Veterinary Medical Products
    EU Annex 5 Manufacture of Immunological Veterinary Medical Products
    EU Annex 6 Manufacture of Medicinal Gases
    EU Annex 7 Manufacture of Herbal Medicinal Products
    EU Annex 8 Sampling of Starting and Packaging Materials
    EU Annex 9 Manufacture of Liquids Creams and Ointments
    EU Annex 10 Inhalation Products
    EU Annex 11 Computerized Systems
    EU Annex 12 Ionizing Radiation
    EU Annex 13 Investigational medicinal Products
    EU Annex 14 Human Blood or Plasma Products
    EU Annex 15 Qualification and Validation
    EU Annex 16 Qualified Person and Batch Release
    EU Annex 17 Parametric Release
    EU Annex 19 Reference and Retention Samples
   
ICH International Conference of Harmonization (ICH)
    ICH E2A - Clinical Safety Data MGMT Def and Standards for Expedited Reporting
    ICH E4 - Dose-Response Information to Support Drug Registration
    ICH E6 - Good Clinical Practice
    ICH E8 - General Considerations for Clinical Trials
    ICH M3 - Nonclinical Safety Studies for the Conduct of Human Clinical Trials
    ICH Q1A - Stability Testing of New Drug Substances and Products
    ICH Q1B - Stability Testing - Photostability Testing of New Drug Substances
    ICH Q1C - Stability Testing for new Dosage Forms
    ICH Q1E - Evaluation of Stability Data
    ICH Q2 - Validation of Analytical Procedures - Test and Methodology
    ICH Q3A - Impurities in New Substances
    ICH Q3B - Impurities in New Products
    ICH Q3C - Impurities - Guideline for Residual Solvents
    ICH Q5A - Viral Safety Evaluation of Biotech Products Derived from Cell Lines
    ICH Q5B - Cell Usage of r-DNA Derived Protein Products
    ICH Q5C - Stability Testing of Biotechnological Biological Products
    ICH Q5D - Derivation and Charact of Cell Substrates Used for Biological Products
    ICH Q5E - Comparability of Biotech Products Subject to Changes in their Manuf Process
    ICH Q6A - Specifications - Test Procedures and Acceptance Criteria for New Drug
    ICH Q6B - Specifications - Test Procedures and Acceptance Criteria Biotech Products
    ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
    ICH Q8 - Pharmaceutical Development
    ICH Q9 - Quality Risk Management
    ICH Q10 - Pharmaceutical Quality System
   ICH Q11 - Development and Manufacture of Drug Substances
    ICH Q8 - 9 - 10 - Questions and Answers
    ICH S2 - Genotoxicity Testing and Data Interpretation for Pharmaceuticals
    ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
    ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals
   
Directives and Other International Guidance
  2017/745 Medical Device Directive
  2017-746 In Vitro Diagnostic Medical Devices
  Drug Manufacturing Inspections
  Program 7356-002
  Canadian GMP - Good Manufacturing Practices Guidelines 2019 EDITION GUI-0001
  Canadian GCP - Drugs for Clinical Trials Involving Human Subjects
  Canadian - Annex 2 GMP Guidelines - Manufacture of Drugs Used in Clinical Trials
  Canadian - SOR98-282 Medical Devices Regulations
  Japanese GMP for Drugs and Quasi-drugs - 2005
  EU Clinical Trials Directive
  Medical Device Quality Systems Manuel
  Medical Device Reporting for Manufacturers
  OECD No 1 - General Principal 1
  OECD No 2 - Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice
  OECD No 3 - Revised Guidance for the Conduct of Laboratory Inspections and Study Audit
  OECD No 4 - Quality Assurance and GLP
  OECD No 5 - Compliance of Laboratory Suppliers with GLP Principles
  OECD No 6 - The Application of the GLP Principles to Field Studies
  OECD No 7 - The Application of the GLP Principles to Short Term Studies
  OECD No 8 - The Role and Responsibilities of the Study Director in GLP Studies
  OECD No 9 - Guidance for the Preparation of GLP Inspection Reports
  OECD No 11 - The Role and Responsibility of the Sponsor in the Application of the Principles of GLP
  OECD No 12 - Requesting and Carrying Out Inspections and Study Audits in Another Country
  OECD No 13 - The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies
  OECD No 14 - The Application of the Principles of GLP to in vitro Studies
  OECD No 15 - Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
  OECD No 16 - Guidance on the GLP Requirements for Peer Review of Histopathology
  OECD No 17 - Application of GLP Principles to Computerised Systems
  OECD No 18 - OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025
 
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