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GMP Publications - Code of Federal Regulation Handbooks by the FDA

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- 21 CFR 820 - Quality System Regulations

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Option: Purchase with Supplemental 2026 Update (as of 2 February 2024)		 https://www.gmppublications.com/Part820.htm

- 21 CFR 210/211 - Drug GMPs - The basic GMPs for every Employee!

...address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

A great training and information tool providing employees with the CFR requirements for Drug, and Combination Products supporting OTC and Ethical manufacturing.

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- 21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook

For Companies that manufacture Drug, Medical Device and Combination Products. 

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- US FDA - European and Japanese GMPs

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 https://www.gmppublications.com/USEUJapaneseGMPHandbook.htm

- GMP International Pharmaceutical Master Reference Guide - Over 900 pages of Guidance and Regulations

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- GMP Medical Device Master Reference Guide - Over 900 pages including EU Directive 2017/745

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Standard Condensed Sterile Product Manufacturing Handbook

EU GMP Annex 1 Manufacturing of Sterile Medicinal Products (2023) with Parts 11, 210/211 and ICH Q7
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https://www.gmppublications.com/SterileProduct.htm

GMP Sterile Manufacturing Handbook - Drug, Biologics, Vaccines & APIs -
Over 450 pages of Regulations and Guidance. Great for CMOs and GCP Industry.

NEW! Master EU GMP Annex 1 Mfg of Sterile Medicinal Products (August 2023)

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- 21 CFR Parts 210/211, Part 11 Electronic Systems and 820 QSR for Device

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US FDA, Canadian and European Medical Device Regulations

Complete with US 21 CFR Part 11, Part 820 Quality Regulations, US FDA QSIT, TAG Auditor's Checklist, Canada SOR 98-282 and EU MDR 2017/745 Medical Device Regulations
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- 21 CFR Part 820, Quality Manual with Audit Checklist with ISO 13485 References

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- 21 CFR 112 Produce for Human Consumption also in a combination English / Spanish

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- 21 CFR Part 112 Produce for Human Consumption in both English and Spanish

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- 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - GCP Medical Device Combination

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- 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - IND/NDA Good Clinical Practice Handbook

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- Dietary Supplement Master Handbook - Includes Guides and Regulations for Supplements

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- 21 CFR Part 117 - Food GMPs - Hazard Analysis, and Risk-Based Preventive Controls for Human Food

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https://www.gmppublications.com/Part117.htm

Other Master Regulations and Guidance Handbooks - Pricing Discounts Available:
Our New and Best Sellers - Don't Forget to Try out Mix and Match Parts!  Create Your Own Handbooks (minimum Qty applies):
2023 National Conference on Interstate Milk Shipments (NCIMS) 4 Book Set
2023 National Conference on Interstate Shipments (NCIMS) – Grade “A” Pasteurized Milk Ordinance
2023 National Conference on Interstate Shipments (NCIMS) – Methods for Making Sanitation Rating of Milk Shippers
2023 National Conference on Interstate Shipments (NCIMS) – Procedures, Include the Constitution and Bylaws
2023 National Conference on Interstate Shipments (NCIMS) – Evaluation of Milk Laboratories
21 CFR 101, 110 and 117 - Food Labeling Combination
21 CFR 106, 107, 110 and 117 - Infant Formula Regulations
21 CFR 108, 110, 113, 114 and 117 - GMPs for Low-Acid Foods
21 CFR 11 - Electronic Records with Scope & Application
21 CFR 11 - Electronic Records with Scope & Application and Part 11 Checklist
21 CFR 11 - Electronic Records with Scope & Application and Preambles
21 CFR 11 - with Scope & Application & Computerized Systems used in Clinical Investigations
21 CFR 11, 101, 110, 117, 120, 123 - GMPs for Fish Industry with Food Labeling
21 CFR 11, 110, 111 and 117 - Food and Supplement GMPs
21 CFR 11, 110, 117, 120 - Food GMPs
21 CFR 11, 110, 117, 120, 123 - GMPs for Fish Industry
21 CFR 11, 110, and 117 - Electronic Records with Food GMPs
21 CFR 11, 111 - Electronic Records with Dietary Supplement GMPs
21 CFR 11, 203, 205 - PDMA with Electronic Records
21 CFR 11, 210/211 - Electronic Records with Drug GMPs
21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH
21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH
21 CFR 11, 210/211 with Keyword Index
21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs
21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug"
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs -ENGLISH/SPANISH
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH
21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook
21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook
Updated 2024 - 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook
Updated 2024 - 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination
21 CFR 11, 58 - Electronic Records with Scope & App. and GLP
21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs
21 CFR 11, 58, 210/211, 820 - Master GMP Trainer
21 CFR 11, 58, 210/211, 820, ICH E6(R2) - GMP 2 Combination Handbook
21 CFR 11, 58, 820 - Electronic Records with GLP and QSR
21 CFR 11, 606 - Electronic Systems with Blood Industry GMPs
21 CFR 11, 820 - Electronic Records with Quality Systems Regulations
21 CFR 11, 820 QSR and 830 UDI
21 CFR 110, 117, 130, 131, 133 - Milk and Dairy
21 CFR 111 - Dietary Supplement handbook
21 CFR 112 - Produce for Human Consumption - ENGLISH/SPANISH
21 CFR 112 - Produce for Human Consumption - SPANISH
21 CFR 112 Produce for Human Consumption
21 CFR 115 and 118 Egg Products
21 CFR 117 - cGMPs for Human Food - ENGLISH/SPANISH
21 CFR 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products
21 CFR 13 - Public Hearing
21 CFR 200 - General Drug
21 CFR 200, 201 - General Drug & Drug Labeling Combination
21 CFR 203 - Prescription Drug Marketing
21 CFR 205 - Guidelines for Licensing of Wholesale Drug
21 CFR 210/211 - Drug GMPs
21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH
21 CFR 210/211 - Drug GMPs-SPANISH
21 CFR 210/211 with Drug Preambles
21 CFR 210/211 with GMP Audit Check List
21 CFR 210/211 with Keyword Index
21 CFR 3 - Combination Product Basic Handbook - Definition, FAQ's & GMPs
21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master
Updated 2024 - 21 CFR 312 - Investigational New Drug Application
Updated 2024 - 21 CFR 312, 314, 511 - Human and Animal Drug Approval
21 CFR 314 - Applications for FDA Approval to Market a New Drug
21 CFR 316 - Orphan Drugs
21 CFR 320 - Bioavailability and Bioequivalence Requirements
21 CFR 4 - Regulation of Combination Products
Updated 2024 - 21 CFR 50 - Protection of Human Subjects
Updated 2024 - 21 CFR 50, 54, 56 - GCP Drug Approval Handbook
21 CFR 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 56 - Institutional Review Boards
21 CFR 58 - Good Laboratory Practice
21 CFR 58, 606 - Good Laboratory Practice for Blood Industry
21 CFR 58, 820 - GLP and QSR
21 CFR 600 - Biological Products: General
21 CFR 600, 601, 610 - Biologic GMP
21 CFR 601 - Licensing - Biologics
21 CFR 606 - Blood Industry
21 CFR 610 - General Biological Products Standards
21 CFR 640 - Add. Standards for human blood and blood products
21 CFR 660 - Add. Standards for Diagnostic Substances for Lab. Tests
21 CFR 680 - Additional Standards for Miscellaneous Products
21 CFR 801 - Labeling - Medical Device
21 CFR 803 - Medical Device Reporting
21 CFR 806 - Medical Devices; Reports of Corrections and Removal
21 CFR 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
21 CFR 809 - In-Vitro Diagnostic Products
21 CFR 810 - Medical Device Recall Authority
Updated 2024 - 21 CFR 812 - Investigational Device Exemptions
21 CFR 814 - Premarket Approval of Medical Device
21 CFR 820 - Quality System Regulations
21 CFR 820 - Quality System Regulations-ENGLISH/SPANISH
21 CFR 820 - Quality System Regulations-SPANISH
21 CFR Part 112 Produce and 117 Food GMPs
21 CFR Part 117 - Food GMPs
21 CFR Part 121 Mitigation Strategies
21 CFR Part 207 Registration
21 CFR Parte 117 - cGMPs for Human Food - SPANISH
21 CFR Parts 112 and 117 - ENGLISH/SPANISH
503B Compounding Master Guide
510k and PMA Guidelines
Advertise - FDA.com & GXPNews E-Newsletter
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
Canadian - SOR98-282 Medical Devices Regulations
Canadian GMP Guidelines GUI-0001 July 1, 2020
Chinese GMPs - NMPA - State Food & Drug Administration P.R. CHINA
Clinical Master Reference Guide
Dietary Supplement Master Handbook
Electronic Systems Master Handbook 1
EU and US GMPs with Annex 1
EU and US GMPs with Annexes 11 and 15
EU and US GMPs with Q7 API
EU cGMPs for ATMP - 2018: Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products
EU cGMPs for ATMP with EU GMP Chapters 1-9
EU cGMPs for ATMP with EU GMP Chapters 1-9 and Annexes 1, 8, 11, 13, 14, 15, 16 & 19
EU GMPs Chapter 1 - 9
EU GMPs with Annex 1 Sterile Medicinal Products
EU GMPs with Annex 10 Inhalation Products
EU GMPs with Annex 11 Computerized Systems
EU GMPs with Annex 11, 15 - Computerized Systems and Validation
EU GMPs with Annex 11, 15, 16 and ICH Q7
EU GMPs with Annex 11, 15, 16, 18, 19
EU GMPs with Annex 12 Ionizing Radiation
EU GMPs with Annex 13 Investigational medicinal Products
EU GMPs with Annex 14 Human Blood or Plasma Products
EU GMPs with Annex 15 Qualification and Validation
EU GMPs with Annex 16 Qualified Person and Batch Release
EU GMPs with Annex 17 Parametric Release
EU GMPs with Annex 19 Reference and Retention Samples
EU GMPs with Annex 2 Biological
EU GMPs with Annex 3 RadioPharma
EU GMPs with Annex 4 Vet. products other than Immuno
EU GMPs with Annex 5 Immunolgical Vet. Products
EU GMPs with Annex 6 Manufacture of Medicinal Gases
EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products
EU GMPs with Annex 8 Sampling of Starting and Packaging Materials
EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments
EU GMPs with ICH Q7
EU GMPs with ICH Q7, Q8(R2), Q9(R1) and Q10
Eudralex - Pharmacovigilance for Medical Products Volume 9a
FDA DEA GMP Master Reference Guide
GLP Master Handbook
GMP - PAT Handbook
GMP Boot Camp Training Certificate and GMP Handbook
GMP International Master Reference Guide
GMP Manufacturing Handbook
GMP Medical Device Master Reference Guide
ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH E4 - Dose-Response Information to Support Drug Registration
ICH E6(R2) - Good Clinical Practice
ICH E8 - General Considerations for Clinical Studies
ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
ICH Q10 - Pharmaceutical Quality System
ICH Q12 Pharmaceutical Product Lifecycle Management
ICH Q1A(R2) - Stability Testing of New Drug Substances and Products
ICH Q1E - Evaluation of Stability Data
ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology
ICH Q5E - Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
ICH Q7 with Q7 Auditors Check List
ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination
ICH Q7, Q8(R2), Q9(R1) and Q10 Combination
ICH Q7, Q8(R2), Q9(R1) and Q10 with FAQ
ICH Q7, Q8(R2), Q9(R1), Q10 and Q11
ICH Q8(R2) - Pharmaceutical Development
ICH Q9(R1) - Quality Risk Management
ICH S2(R1) - Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals
In Vitro Diagnostics 2017/746 Medical Devices
In Vitro Diagnostics Master Handbook
Japanese GMP for Drugs and Quasi-drugs - 2005
Job Posting - FDA.COM & GXPNews Per Week
Medical Device Clinical with EU Directive
Medical Device Combination 2 - 21 CFR Part 11, Part 820 and EU 2017/745
Medical Device QSIT Manual with 11 and 820
Medical Device QSIT Manual with 11, 803, 806, 820 and 821
Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist
Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT
Medical Device Quality Systems Manual with 820 and QSR Audit Checklist
Standard Sterile Product Manufacturing Handbook
Title 21 CFR Parts 1 - End Nine Volume Set
US and Canadian GMPs with ICH Q7, Q8(R2), Q9(R1), Q10
US and EU GMPs with ICH Q7, Q8(R2), Q9(R1), Q10
US FDA, Canadian and European MDR
US, EU and Canadian Medical Device Combination
US, EU and Japanese GMPs
VICH GL9 Animal GCP
30 Day Posting Pack
GMP Audit - 1 Day Onsite All Inclusive
21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024
21 CFR Part 4 Regulations for Combination Devices with 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024
21 CFR 11, 110, 112, 117, 120 - Produce cGMPs -
ICH Q2(R2) and ICH Q14 Analytical Validation
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
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