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Welcome to GMP Publications
Code of Federal Regulations, CFRs, FDA, GMP, Part 11, 21 CFR Part 11, 210/211, 21 CFR Part 820, QSR, GLP, GCP, 21 CFR Part 210-211, 21 CFR Part 58, 21 CFR Part 111, Drug, Biologic, Medical Device, 21 CFR Part 600, 21 CFR, Title 21, FDA
Code of Federal Regulations Mini-Handbooks as provided by the Food and Drug Administration FDA. The laws for Pharmaceuticals, BioTechnology, Medical Device and Regulatory Industry. Quality Assurance QA, Blood, Biologics, Drug and Food Industry
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Внутренние ссылки главной страницы ( 187 ) | |
gmppublications.com/index.htm | Most Popular |
gmppublications.com/iGMPs.htm | Drug GMPs |
gmppublications.com/iDevices.htm | Medical Devices |
# | Contact Us |
gmppublications.com/iClinical.htm | Clinical |
gmppublications.com/iLaboratory.htm | Laboratory |
gmppublications.com/iBiologics.htm | Biologics |
gmppublications.com/iBlood.htm | Blood |
gmppublications.com/iTissue.htm | Tissue |
gmppublications.com/iCosmetic.htm | Cosmetic |
gmppublications.com/iFood.htm | Food |
gmppublications.com/iDietary.htm | Dietary |
gmppublications.com/iMisc.htm | UE-ICH-CAN-JAP-SING |
gmppublications.com/iComputer.htm | 21 CFR Part 11 |
gmppublications.com/210211DrugGMPs.htm | 21 CFR 210/211 - Drug GMPs |
gmppublications.com/Part820.htm | 21 CFR 820 - Quality System Regulations |
gmppublications.com/ProduceGMPs.html | 21 CFR 112 Produce for Human Consumption |
gmppublications.com/standardGMP.htm | <img> |
gmppublications.com/MedicalDeviceCombinationStd.htm | <img> |
gmppublications.com/gcphandbook.htm | <img> |
gmppublications.com/gmpmasterhandbook.htm | GMP International Master Reference Guide |
gmppublications.com/Part117.htm | 21 CFR Part 117 - Food GMPs |
gmppublications.com/MedicalDeviceMasterGuide.htm | GMP Medical Device Master Reference Guide |
gmppublications.com/product72.html | 21 CFR 3 - Combination Product Basic Handbook - Definition, FAQ's & GMPs |
gmppublications.com/CombinationProductHandbook2.htm | 21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master |
gmppublications.com/product191.html | 21 CFR 4 - cGMP for Combination Products |
gmppublications.com/Part11withScopeApplication.htm | 21 CFR 11 - Electronic Records with Scope & Application |
gmppublications.com/11andPart11Checklist.htm | 21 CFR 11 - Electronic Records with Scope & Application and Part 11 Checklist |
gmppublications.com/Part 11withScopeApplicationwPreambles.ht... | 21 CFR 11 - Electronic Records with Scope & Application and Preambles |
gmppublications.com/Part11wCSUICI.htm | 21 CFR 11 - with Scope & Application & Computerized Systems used in Clinical Investigations |
gmppublications.com/GMPsFishIndustrywith101.htm | 21 CFR 11, 101, 110, 117, 120, 123 - GMPs for Fish Industry with Food Labeling |
gmppublications.com/product139.html | 21 CFR 11, 110, 111 and 117 - Food and Supplement GMPs |
gmppublications.com/product203.html | 21 CFR 11, 110, 117, 120 - Food GMPs |
gmppublications.com/GMPsFishIndustryParts11-110-120and123.ht... | 21 CFR 11, 110, 117, 120, 123 - GMPs for Fish Industry |
gmppublications.com/Part11and111.htm | 21 CFR 11, 111 - Electronic Records with Dietary Supplement GMPs |
gmppublications.com/PDMA-Parts11w203w205.htm | 21 CFR 11, 203, 205 - PDMA with Electronic Records |
gmppublications.com/Parts11and210211.htm | 21 CFR 11, 210/211 - Electronic Records with Drug GMPs |
gmppublications.com/Part11and210211EnglishSpanish.htm | 21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH |
gmppublications.com/Part11and210211Spanish.htm | 21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH |
gmppublications.com/Part210211withKeywordIndexandPart11.htm | 21 CFR 11, 210/211 with Keyword Index |
gmppublications.com/Blood-QSR-GMPs.htm | 21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs |
gmppublications.com/CosmeticGMPs.htm | 21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug" |
gmppublications.com/Part11w210211w820.htm | 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs |
gmppublications.com/Part11w210211w820wEnglishSpanish.htm | 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs -ENGLISH/SPANISH |
gmppublications.com/Part11w210211w820wSpanish.htm | 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH |
gmppublications.com/GMPAuditorBasicHandbook.htm | 21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditors Basic Handbook |
gmppublications.com/Part58GLPand11.htm | 21 CFR 11, 58 - Electronic Records with Scope & App. and GLP |
gmppublications.com/Multi-USGMPs.htm | 21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs |
gmppublications.com/MasterGMPTrainerCombo.htm | 21 CFR 11, 58, 210/211, 820 - Master GMP Trainer: Guidance Doc. GMPs for the 21st Century & Quality Syst. Approach to GMPs |
gmppublications.com/GMP2.htm | 21 CFR 11, 58, 210/211, 820, ICH E6(R2) - GMP 2 Combination Handbook |
gmppublications.com/Part11w58w820.htm | 21 CFR 11, 58, 820 - Electronic Records with GLP and QSR |
gmppublications.com/Part11and606.htm | 21 CFR 11, 606 - Electronic Systems with Blood Industry GMPs |
gmppublications.com/Part11w820.htm | 21 CFR 11, 820 - Electronic Records with Quality Systems Regulations |
gmppublications.com/product205.html | 21 CFR 11, 820 QSR and 830 UDI |
gmppublications.com/Part13.htm | 21 CFR 13 - Public Hearing |
gmppublications.com/Part50.htm | 21 CFR 50 - Protection of Human Subjects |
gmppublications.com/Part50w54w56.htm | 21 CFR 50, 54, 56 - GCP Drug Approval Handbook |
gmppublications.com/Part54.htm | 21 CFR 54 - Financial Disclosure by Clinical Investigators |
gmppublications.com/Part56.htm | 21 CFR 56 - Institutional Review Boards |
gmppublications.com/Part58GLP.htm | 21 CFR 58 - Good Laboratory Practice |
gmppublications.com/Part58GLPand606.htm | 21 CFR 58, 606 - Good Laboratory Practice for Blood Industry |
gmppublications.com/Part58GLPand820QSR.htm | 21 CFR 58, 820 - GLP and QSR |
gmppublications.com/Part101w110.htm | 21 CFR 101, 110 and 117 - Food Labeling Combination |
gmppublications.com/InfantFormulaParts106w107w110.htm | 21 CFR 106, 107, 110 and 117 - Infant Formula Regulations |
gmppublications.com/GMPsforLow-AcidFoods.htm | 21 CFR 108, 110, 113, 114 and 117 - GMPs for Low-Acid Foods |
gmppublications.com/MilkDairyParts110w130w131w133.htm | 21 CFR 110, 117, 130, 131, 133 - Milk and Dairy |
gmppublications.com/111info.htm | 21 CFR 111 - Dietary Supplement handbook |
gmppublications.com/product250.html | 21 CFR Part 112 Produce and 117 Food GMPs |
gmppublications.com/product178.html | 21 CFR 115 and 118 Egg Products |
gmppublications.com/Part200.htm | 21 CFR 200 - General Drug |
gmppublications.com/Part201.htm | 21 CFR 200, 201 - General Drug & Drug Labeling Combination |
gmppublications.com/Part203.htm | 21 CFR 203 - Prescription Drug Marketing |
gmppublications.com/Part205.htm | 21 CFR 205 - Guidelines for Licensing of Wholesale Drug |
gmppublications.com/Part210211wDrugGMPswEnglishSpanish.htm | 21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH |
gmppublications.com/Part210211DrugGMPsSpanish.htm | 21 CFR 210/211 - Drug GMPs-SPANISH |
gmppublications.com/Drug210211Preambles.htm | 21 CFR 210/211 with Drug Preambles |
gmppublications.com/product173.html | 21 CFR 210/211 with GMP Audit Check List |
gmppublications.com/Part210211withKeywordIndex.htm | 21 CFR 210/211 with Keyword Index |
gmppublications.com/Part312.htm | 21 CFR 312 - Investigational New Drug Application |
gmppublications.com/Part312w314w511.htm | 21 CFR 312, 314, 511 - Human and Animal Drug Approval |
gmppublications.com/Part314.htm | 21 CFR 314 - Applications for FDA Approval to Market a New Drug |
gmppublications.com/Part316.htm | 21 CFR 316 - Orphan Drugs |
gmppublications.com/product189.html | 21 CFR 320 - Bioavailability and Bioequivalence Requirements |
gmppublications.com/21CFRPart507.html | 21 CFR 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals |
gmppublications.com/Part600.htm | 21 CFR 600 - Biological Products: General |
gmppublications.com/BiologicGMP-Parts600w601w610.htm | 21 CFR 600, 601, 610 - Biologic GMP |
gmppublications.com/Part601.htm | 21 CFR 601 - Licensing - Biologics |
gmppublications.com/Part606.htm | 21 CFR 606 - Blood Industry |
gmppublications.com/Part610.htm | 21 CFR 610 - General Biological Products Standards |
gmppublications.com/Part640.htm | 21 CFR 640 - Add. Standards for human blood and blood products |
gmppublications.com/Part660.htm | 21 CFR 660 - Add. Standards for Diagnostic Substances for Lab. Tests |
gmppublications.com/Part680.htm | 21 CFR 680 - Additional Standards for Miscellaneous Products |
gmppublications.com/Part801.htm | 21 CFR 801 - Labeling - Medical Device |
gmppublications.com/Part803.htm | 21 CFR 803 - Medical Device Reporting |
gmppublications.com/Part806.htm | 21 CFR 806 - Medical Devices; Reports of Corrections and Removal |
gmppublications.com/Part807.htm | 21 CFR 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices |
gmppublications.com/Part809.htm | 21 CFR 809 - In-Vitro Diagnostic Products |
gmppublications.com/Part810.htm | 21 CFR 810 - Medical Device Recall Authority |
gmppublications.com/Part812.htm | 21 CFR 812 - Investigational Device Exemptions |
gmppublications.com/Part814.htm | 21 CFR 814 - Premarket Approval of Medical Device |
gmppublications.com/Part820-EnglishSpanish.htm | 21 CFR 820 - Quality System Regulations-ENGLISH/SPANISH |
gmppublications.com/Part820-Spanish.htm | 21 CFR 820 - Quality System Regulations-SPANISH |
gmppublications.com/QSITwith820.htm | 21 CFR 820 with Medical Device QSIT Manual |
gmppublications.com/Part1270.htm | 21 CFR 1270 - Human Tissue Intended for Transplantation |
gmppublications.com/Part1271.htm | 21 CFR 1271 - Human Cells, Tissues, Cellular and Tissue |
gmppublications.com/Part1270w1271.htm | 21 CFR 1270, 1271 - Cell Tissue |
gmppublications.com/jobposting.html | 30 Day Posting Pack |
gmppublications.com/503BCompoundingPackaging.htm | 503B Compounding and Packaging |
gmppublications.com/PMAand510k.htm | 510k and PMA Guidelines |
gmppublications.com/canadiangmpdetails.htm | Canadian GMP Guidelines GUI-0001 2018 |
gmppublications.com/ChineseGMPs.htm | Chinese GMPs -SFDA - State Food & Drug Administration P.R. CHINA |
gmppublications.com/gcpmasterhandbook.htm | Clinical Master Reference Guide |
gmppublications.com/DietarySupplements.htm | Dietary Supplement Master Handbook |
gmppublications.com/ElectronicSystemsMasterHandbook1.htm | Electronic Systems Master Handbook 1 |
gmppublications.com/EUUSGMPswithAnnex1.htm | EU and US GMPs with Annex 1 |
gmppublications.com/EUUSGMPswithAnnexes11and15.htm | EU and US GMPs with Annexes 11 and 15 |
gmppublications.com/EUUSGMPswithICH78910.htm | US and EU GMPs with ICH Q7, Q8(R2), Q9, Q10 |
gmppublications.com/EUGMPswithUSStandardGMPs.htm | EU and US GMPs with Q7 API |
gmppublications.com/EUGMPsChapter1-9.htm | EU GMPs Chapter 1 - 9 |
gmppublications.com/EUGMPswithAnnex1.htm | EU GMPs with Annex 1 Sterile Medicinal Products |
gmppublications.com/EUGMPswithAnnex10.htm | EU GMPs with Annex 10 Inhalation Products |
gmppublications.com/EUGMPswithAnnex11.htm | EU GMPs with Annex 11 Computerized Systems |
gmppublications.com/EUGMPswithAnnexes11and15.htm | EU GMPs with Annex 11, 15 - Computerized Systems and Validation |
gmppublications.com/EUGMPswithAnnex11w15w16andICHQ7.htm | EU GMPs with Annex 11, 15, 16 and ICH Q7 |
gmppublications.com/EUGMPswithAnnex11w15w16w18w19.htm | EU GMPs with Annex 11, 15, 16, 18, 19 |
gmppublications.com/EUGMPswithAnnex12.htm | EU GMPs with Annex 12 Ionizing Radiation |
gmppublications.com/EUGMPswithAnnex13.htm | EU GMPs with Annex 13 Investigational medicinal Products |
gmppublications.com/EUGMPswithAnnex14.htm | EU GMPs with Annex 14 Human Blood or Plasma Products |
gmppublications.com/EUGMPswithAnnex15.htm | EU GMPs with Annex 15 Qualification and Validation |
gmppublications.com/EUGMPswithAnnex16.htm | EU GMPs with Annex 16 Qualified Person and Batch Release |
gmppublications.com/EUGMPswithAnnex17.htm | EU GMPs with Annex 17 Parametric Release |
gmppublications.com/EUGMPswithAnnex19.htm | EU GMPs with Annex 19 Reference and Retention Samples |
gmppublications.com/EUGMPswithAnnex2.htm | EU GMPs with Annex 2 Biological |
gmppublications.com/EUGMPswithAnnex3.htm | EU GMPs with Annex 3 RadioPharma |
gmppublications.com/EUGMPswithAnnex4.htm | EU GMPs with Annex 4 Vet. products other than Immuno |
gmppublications.com/EUGMPswithAnnex5.htm | EU GMPs with Annex 5 Immunolgical Vet. Products |
gmppublications.com/EUGMPswithAnnex6.htm | EU GMPs with Annex 6 Manufacture of Medicinal Gases |
gmppublications.com/EUGMPswithAnnex7.htm | EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products |
gmppublications.com/EUGMPswithAnnex8.htm | EU GMPs with Annex 8 Sampling of Starting and Packaging Materials |
gmppublications.com/EUGMPswithAnnex9.htm | EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments |
gmppublications.com/EUGMPswithQ7.htm | EU GMPs with ICH Q7 |
gmppublications.com/EUGMPswithQ7Q8Q9Q10.htm | EU GMPs with ICH Q7, Q8(R2), Q9 and Q10 |
gmppublications.com/Pharmacovil9adetails.htm | Eudralex - Pharmacovigilance for Medical Products Volume 9a |
gmppublications.com/DEAControlledSubstancesGMP.htm | <img> |
gmppublications.com/glpmasterhandbook.htm | GLP Master Handbook |
gmppublications.com/GMP-PAT.htm | GMP - PAT Handbook |
gmppublications.com/ICHE2A.htm | ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting |
gmppublications.com/ICHE4.htm | ICH E4 - Dose-Response Information to Support Drug Registration |
gmppublications.com/ICHE6.htm | ICH E6(R2) - Good Clinical Practice |
gmppublications.com/ICHE8.htm | ICH E8 - General Considerations for Clinical Trials |
gmppublications.com/ICHM3.htm | ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pha... |
gmppublications.com/ICHQ10.htm | ICH Q10 - Pharmaceutical Quality System |
gmppublications.com/ICHQ1A.htm | ICH Q1A(R2) - Stability Testing of New Drug Substances and Products |
gmppublications.com/ICHQ1E.htm | ICH Q1E - Evaluation of Stability Data |
gmppublications.com/ICHQ2.htm | ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology |
gmppublications.com/ICHQ5E.htm | ICH Q5E - Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process |
gmppublications.com/product180.html | ICH Q7 with Q7 Auditors Check List |
gmppublications.com/ICHQ7Q8Q9Q10.htm | ICH Q7, Q8(R2), Q9 and Q10 Combination |
gmppublications.com/7-8-9-10wFAQ.htm | ICH Q7, Q8(R2), Q9 and Q10 with FAQ |
gmppublications.com/product185.html | ICH Q7, Q8, Q9, Q10 and Q11 |
gmppublications.com/ICHQ8.htm | ICH Q8(R2) - Pharmaceutical Development |
gmppublications.com/ICHQ9.htm | ICH Q9 - Quality Risk Management |
gmppublications.com/ICHS2A.htm | ICH S2(R1) - Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use |
gmppublications.com/ICHS6.htm | ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
gmppublications.com/ICHS7A.htm | ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals |
gmppublications.com/product183.html | In Vitro Diagnostics 2017/746 Medical Devices |
gmppublications.com/InVitroMaster.htm | In Vitro Diagnostics Master Handbook |
gmppublications.com/JapaneseGMP.htm | Japanese GMP for Drugs and Quasi-drugs - 2005 |
gmppublications.com/MedDeviceClinicalw11w50w54w56w312w812wE2... | Medical Device Clinical with EU Directive |
gmppublications.com/MedicalDeviceCombination2.htm | Medical Device Combination 2 - 21 CFR Part 11, Part 820 and EU 2017/745 |
gmppublications.com/QSITwithParts11and820.htm | Medical Device QSIT Manual with 11 and 820 |
gmppublications.com/QSITwParts11w803w806w820w821.htm | Medical Device QSIT Manual with 11, 803, 806, 820 and 821 |
gmppublications.com/MDQSManualw11w210211w820wChecklist.htm | Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist |
gmppublications.com/MedicalDeviceMaster.html | Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT |
gmppublications.com/QSManual820CheckList.htm | Medical Device Quality Systems Manual with 820 and QSR Audit Checklist |
gmppublications.com/21CFR9VolumeSet.htm | Title 21 CFR Parts 1 - End Nine Volume Set |
gmppublications.com/USCandianICHGMPHandbook.htm | US and Canadian GMPs with ICH Q7, Q8(R2), Q9, Q10 |
gmppublications.com/EUUSCanDevice5.htm | US, EU and Canadian Medical Device Combination |
gmppublications.com/USEUJapaneseGMPHandbook.htm | <img> |
gmppublications.com/product182.html | VICH GL9 Animal GCP |
gmppublications.com/Canadian-SOR98-282-Medical-Devices-Regul... | Canadian - SOR98-282 Medical Devices Regulations |
gmppublications.com/iQuote.htm | <img> |
gmppublications.com/newhandbooks.htm | <img> |
gmppublications.com/iAbout.htm | About Us |
gmppublications.com/iReturns.htm | Guarantee & Return Policy |
gmppublications.com/iLinks.htm | Links |
gmppublications.com/iContact.htm | Contact Us |
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