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Get the Regulations and Guidance Handbooks:

21 CFR 210/211 - Drug GMPs - Add Parts 11 Electronic Systems and 820 QSR for Device

21 CFR 820 - Quality System Regulations - Include Audit Checklist with ISO 13485 References

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

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

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

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

GMP International Pharma. Master Reference Guide - 900+ pages of Guidance and Regulations

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

Dietary Supplement Master Handbook - Includes Guides and Regulations for Supplements

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

In Vitro Diagnostics Master Handbook - Over 500 Pages including EU Directive 2017/746

Don't see what you are looking for? Contact John Cuspilich, QA/RA, at jcuspilich@fda.com
Other Inventory: Handbooks are up-to-date as of date purchased!

21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product Master

21 CFR 4 - cGMP for Combination Products

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 & Appl. & 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, 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 Record, Drug, Blood & Device

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

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

21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Master2

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

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 13 - Public Hearing

21 CFR 50 - Protection of Human Subjects

21 CFR 50, 54, 56 - GCP Drug Approval Handbook

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 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 110, 117, 130, 131, 133 - Milk and Dairy

21 CFR 111 - Dietary Supplement handbook

21 CFR 112 Produce for Human Consumption

21 CFR Part 112 Produce and 117 Food GMPs

21 CFR 115 and 118 Egg Products

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 312 - Investigational New Drug Application

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 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls

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 - Estab. Reg. and Device Listing for Manufacturers and Initial Importers of Devices

21 CFR 809 - In-Vitro Diagnostic Products

21 CFR 810 - Medical Device Recall Authority

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 820 with Medical Device QSIT Manual

21 CFR Part 117 - Food GMPs

21 CFR 1270 - Human Tissue Intended for Transplantation

21 CFR 1271 - Human Cells, Tissues, Cellular and Tissue…

21 CFR 1270, 1271 - Cell Tissue

503B Compounding and Packaging

510k and PMA Guidelines

Canadian GMP Guidelines GUI-0001 2018

Chinese GMPs -SFDA - 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 ICH Q7, Q8(R2), Q9, Q10

EU and US GMPs with Q7 API

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 and Q10

Eudralex - Pharmacovigilance for Medical Products Volume 9a

FDA DEA GMP Master Reference Guide

GLP Master Handbook

GMP - PAT Handbook

GMP International Master Reference Guide

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 Trials

ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials

ICH Q10 - Pharmaceutical Quality System

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

ICH Q7 with Q7 Auditors Check List

ICH Q7, Q8(R2), Q9 and Q10 Combination

ICH Q7, Q8(R2), Q9 and Q10 with FAQ

ICH Q7, Q8, Q9, Q10 and Q11

ICH Q8(R2) - Pharmaceutical Development

ICH Q9 - 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 98/79/EC Medical Devices

In Vitro Diagnostics Master Handbook

Japanese GMP for Drugs and Quasi-drugs - 2005

Medical Device Clinical with EU Directive

Medical Device Combination 2

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

Title 21 CFR Parts 1 - End Nine Volume Set

US and Canadian GMPs with ICH Q7, Q8(R2), Q9, Q10

US, EU and Canadian Medical Device Combination

US, EU and Japanese GMPs

VICH GL9 Animal GCP

Canadian - SOR98-282 Medical Devices Regulations

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