- EMA CPMPICH273899 NOTE FOR GUIDANCE ON IMPURITIES IN NEW DRUG PRODUCTS.pdfCPMPQWP05498 Corr DECISION TREES FOR THE SELECTION OF STERILISATION METHODS.pdfCPMPQWP60996Rev 2 DECLARATION OF STORAGE CONDITIONS IN THE PRODUCT INFORMATION OF MEDICINAL PRODUCTS.pdfEMA5724542014 Rev 17 Compilation of Community Procedures on Inspections and Exchange of Information.pdfEMA6039052013 Questions and answers on Design Space Verification.pdfEMACHMPCVMPQWPBWP702782012-Rev1 Guideline on process validation.pdfEMACHMPCVMPQWPBWP8503742015 Guideline on the sterilisation of the medicinal product, 7 active substance, excipient and primary container.pdfEMAINSGMP3212522012 Rev 15 Compilation of Community Procedures on Inspections.pdfWATER FOR PHARMACEUTICAL USE.pdf
- FDA
- ICH
- Q1 Изучение стабильности Q1A STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS.pdfQ1B PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS.pdfQ1C Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products.pdfQ1D BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS.pdfQ1E EVALUATION FOR STABILITY DATA.pdf
- Q10 Фармацевтическая система качества
- Q11 Разработка и производство активных фармацевтических субстанций
- Q12 Управление жизненным циклом лекарственных препаратов
- Q2 Валидация аналитических методик
- Q3 Примеси Q3A(R2) IMPURITIES IN NEW DRUG SUBSTANCES.pdfQ3B(R2) IMPURITIES IN NEW DRUG PRODUCTS.pdfQ3C-R6 IMPURITIES GUIDELINE FOR RESIDUAL SOLVENTS.pdfQ3C-R8_IMPURITIES GUIDELINE FOR RESIDUAL SOLVENTS_проект.pdfQ3D-R1EWG_GUIDELINE FOR ELEMENTAL IMPURITIES.pdfQ3D-R2_Step2_GUIDELINE FOR ELEMENTAL IMPURITIES_проект.pdf
- Q4 Фармакопеи Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS.pdfQ4B Annex 1(R1) RESIDUE ON IGNITIONSULPHATED ASH GENERAL CHAPTER.pdfQ4B Annex 2(R1) TEST FOR EXTRACTABLE VOLUME OF PARENTERAL PREPARATIONS GENERAL CHAPTER.pdfQ4B Annex 3(R1) TEST FOR PARTICULATE CONTAMINATION SUB-VISIBLE PARTICLES GENERAL CHAPTER.pdfQ4B Annex 5(R1) DISINTEGRATION TEST GENERAL CHAPTER.pdfQ4B Annex 6 UNIFORMITY OF DOSAGE UNITS GENERAL CHAPTER.pdfQ4B Annex 7 (R2) DISSOLUTION TEST GENERAL CHAPTER.pdfQ4B Annex 8(R1) STERILITY TEST GENERAL CHAPTER.pdfQ4B Annex 9(R1) TABLET FRIABILITY GENERAL CHAPTER.pdfQ4B Annex 10(R1) POLYACRYLAMIDE GEL ELECTROPHORESIS GENERAL CHAPTER.pdfQ4B Annex 11 CAPILLARY ELECTROPHORESIS GENERAL CHAPTER.pdfQ4B Annex 12 ANALYTICAL SIEVING GENERAL CHAPTER.pdfQ4B Annex 13 BULK DENSITY AND TAPPED DENSITY OF POWDERS GENERAL CHAPTER.pdfQ4B Annex 14 BACTERIAL ENDOTOXINS TEST GENERAL CHAPTER.pdfQ4B Annex4A(R1) MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS_MICROBIAL ENUMERATIONS TESTS GENERAL CHAPTER.pdfQ4B Annex4B(R1) MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS TEST FOR SPECIFIED MICRO-ORGANISMS GENERAL CHAPTER.pdfQ4B Annex4C(R1) MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE GENERAL.pdf
- Q5 Качество биотехнологической продукции Q5A(R1) VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN.pdfQ5B QUALITY OF BIOTECHNOLOGICAL PRODUCTS ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF R-DNA DERIVED PROTEIN PRODUC.pdfQ5C STABILITY TESTING OF BIOTECHNOLOGICALBIOLOGICAL PRODUCTS.pdfQ5D DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICALBIOLOGICAL PRODUCTS.pdfQ5E COMPARABILITY OF BIOTECHNOLOGICALBIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS.pdf
- Q6 Спецификации
- Q7 Надлежащая производственная практика
- Q8 Фармацевтическая разработка
- Q9 Управление рисками для качества
- PIC/S
- Документы для инспекторатов PI 002-3 QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES.pdfPI 010-5 PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS.pdfPI 013-3 PICS INSPECTION REPORT FORMAT.pdfPI 031-1 TEAM INSPECTIONS.pdfPI 039-1 PROCEDURE TO INFORM FOREIGN REGULATORY AGENCIES OF FOREIGN INSPECTIONS TO BE CONDUCTED IN THEIR JURISDICTION.pdfPI 048-1 GMP INSPECTION RELIANCE.pdfPIC S 1 95 (Rev. 6) PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME.pdfPS W 01 2011 QUESTIONNAIRE FOR COMPETENT AUTHORITIES TO BE USED FOR ASSESSMENT, REASSESSMENT AND SELF-EVALUATION.pdfPSW 1_2005 (Rev. 2) REVISED PICS AUDIT CHECKLIST.pdfPSW 12_2019 GUIDELINES FOR THE PRE-ACCESSION PROCEDURE.pdfPSW 14_2011 (Rev. 2) GUIDELINES FOR ACCESSION.pdfPSW 31_019 PICS AUDIT CHECKLIST - INTERPRETATION GUIDE.pdf
- Документы для инспекторов PE 005-3 PICS GMP GUIDE FOR BLOOD ESTABLISHMENTS.pdfPE 010-4 PICS GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS.pdfPE 011-1 PICS GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS.pdfPI 005-3 GUIDANCE ON PARAMETRIC RELEASE.pdfPI 006-3 VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION.pdfPI 007-6 VALIDATION OF ASEPTIC PROCESSES.pdfPI 008 – 3 PICS GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS AND PLASMA WAREHOUSES (INSPECTION GUIDE).pdfPI 009-4 INSPECTION OF UTILITIES.pdfPI 011-3 GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP” ENVIRONMENTS.pdfPI 012-3 STERILITY TESTING.pdfPI 014-3 ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING.pdfPI 021-2 GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS.pdfPI 023–2 INSPECTION OF PHARMACEUTICAL QUALITY CONTROL LABORATORIES.pdfPI 024-3 INSPECTION OF BIOTECHNOLOGY MANUFACTURES.pdfPI 025-2 INSPECTION OF MEDICINAL GASES.pdfPI 026-2 QUALIFICATION AND TRAINING OF INSPECTORS IN THE FIELD OF HUMAN BLOOD, TISSUES AND CELLS.pdfPI 028-2 GMP INSPECTION RELATED TO PACKAGING.pdfPI 030-1 INSPECTION OF ACTIVE PHARMACEUTICAL INGREDIENTS.pdfPI 032-2 GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS.pdfPI 037-1 A RECOMMENDED MODEL FOR RISK-BASED INSPECTION PLANNING IN THE GMP ENVIRONMENT.pdfPI 038-2 ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION.pdfPI 040-1 PICS GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES.pdfPI 041-1 (Draft 3) GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMPGDP ENVIRONMENTS.pdfPI 043-1 CROSS-CONTAMINATION IN SHARED FACILITIES.pdfPI 045-1 GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS.pdfPI 046-1 GUIDELINE ON SETTING HEALTH BASED EXPOSURE LIMITS FOR USE IN RISK IDENTIFICATION IN THE MANUFACTURE OF DIFFERENT MEDICINALPRODUCTS.pdfPI 047-1 GUIDELINES ON THE PRINCIPLES OF GDP OF ACTIVE SUBSTANCES.pdfPI 052-1 INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL) ASSESSMENTS AND USE IN QUALITY RISK MANAGEMENT.pdfPI 053-1 QUESTIONS AND ANSWERS ON IMPLEMENTATION OF RISK-BASED PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION.pdfPI 054-1 (Draft 1) How to Evaluate Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management.pdfPS INF 6 2012 (Rev. 1) QUESTIONS AND ANSWERS ON TRACEABILITY OF MEDICINAL GASES.pdfPS INF 20 2011 Questions & Answers document regarding Distribution Activities for Active Pharmaceutical Ingredients (APIs).pdfPS INF 88 2019 Concept Note on a Document prepared by the PICS QRM Expert Circle on‘How to Evaluate Demonstrate the Effectiveness of a PQS.pdf
- Документы для промышленности Annex 1 Manufacture of Sterile Products_проект.pdfAnnex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use_проект.pdfPE 008-4 EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERSON THE PREPARATION OF A SITE MASTER FILE.pdfPI 019–3 SITE MASTER FILE FOR SOURCE PLASMA ESTABLISHMENTS.pdfPI 020-3 SITE MASTER FILE FOR PLASMA WAREHOUSES.pdfPS INF 26 2019 (Rev. 1) Annex 2B Manufacture of biological medicinal substances and products for human use_проект.pdf
- Правила надлежащей производственной практики PICS
- WHO
- GMP WHO GMP for biological products.pdfGMP WHO.pdfGMP_For_Biologicals_NEW-2016.pdfGMPActivePharmaceuticalIngredients.pdfGMPBiologicalProductsTRS822Annex3.pdfGMPBloodEstablishments.pdfGMPPharmaceuticalProductsCcontainingHhazardousSubstancesTRS957Annex3.pdfGMPRadiopharmaceuticalProductsTRS908Annex3.pdfGMPSterilePharmaceuticalProductsTRS961Annex6.pdfGuidelines on good manufacturing practices validation.pdfHAACP.pdfInvestigationalPharmaceuticalProductsClinicalTrialsHumansTRS863Annex7.pdfSupplementary guidelines on good manufacturing non-sterile.pdfSupplementary guidelines on good manufacturing.pdfSupplementaryGMPManufactureHerbalMedicinesTRS937Annex3.pdfSupplementaryGMPPharmaceuticalExcipients.pdfWHO good manufacturing practices water.pdf
- Vaccines Annex_3_WHO_TRS_962-3.pdfbatch release.pdfChanges.pdfinterferons.pdfrecombinant inteferons.pdfRecommendations for the evaluation of animal cell cultures .pdfthiomersal.pdfTRS_978_Annex_3 Recommendations for the evaluation of animal cell cultures.pdfWHO_TRS_530_A4.pdfWHO_TRS_822.pdfWHO_TRS_927 (Informe 54).pdfWHO_TRS_977 (Informe 60).pdfYellow fever.pdf
- Всемирная организация здравоохранения WHO
- Взаимозаменяемость AdditionalGuidanceOrganizationPerformInvivoBioequivalenceStudiesTRS937Annex9.pdfAnnex7-TRS992.pdfAnnex8-TRS992.pdfGuidanceSelectionComparatorPharmaceuticalProductsEquivalenceAssessmentInterchangeableMultisourceProductsTRS902Annex11.pdfProposalWaiveVivoBioequivalenceRequirementsModelListEssentialMedicinesImmediateReleaseSolidOralDosageFormsTRS937Annex8.pdf
- Дистрибуция
- Готовые продукты
- Закупки
- Исходные материалы
- Технические приложения introduction.pdfintroduction_v2.pdfsupplement_1_Selecting_sites_for_storage.pdfsupplement_2_Design_and_procurement_of_storage_facilities.pdfsupplement_3_Estimating_the_capacity_of_storage_facilities.pdfsupplement_4_Building_security_and_fire_protection.pdfsupplement_5_Maintenance_of_storage_facilities.pdfsupplement_6_Temperature_and_humidity_monitoring_systems_for_fixed_storage_areas.pdfsupplement_7_Qualification_of_temperature-controlled_storage_areas.pdfsupplement_8_Temperature_mapping_of_storage_areas.pdfsupplement_9_Maintenance_of_refrigeration_equipment.pdfsupplement_10_Checking_the_accuracy_of_temperature_control_and_monitoring_devices.pdfsupplement_11_Qualification_of_refrigerated.pdfsupplement_12_Temperature-controlled_transport_operations_by_road and by air.pdfsupplement_13_Qualification_of_shipping_containers.pdfsupplement_14_Transport_route_profiling_qualification.pdfsupplement_15_Temperature_and_humidity_monitoring_systems_for_transport_operations.pdfsupplement_16_Environmental_management_of refrigeration equipment.pdf
- Хранение
- Инспекция
Annex2_TRS823_Inspection_Pharmaceutical_Manufacturers.pdfAnnex4-TRS992_General_guidance_on_hold_time_studies.pdfAnnex5_TRS908_Model_Certificate_GMP.pdfAnnex6_TRS885_Inspection_Drug_Distribution_Channels.pdfAnnex7_TRS902_Preapproval_Inspections.pdfAnnex8_TRS902_Quality_System_Requirements_National_GMP_Inspectorates.pdfAnnex14_TRS961_Guidelines_Drafting_Site_Master_File.pdfGuidanceGMPInspectionReportTRS908Annex6.pdf- Контроль_качества
9241545135.pdfAnnex1TRS-981.pdfAnnex1-TRS992.pdfConsiderationsRequestingAnalysesDrugSamplesTRS902Annex4.pdfGeneralGuidelinesEstablishmentMaintenanceDistributionChemicaReferenceSubstancesTRS943Annex3.pdfGoodPracticesPharmaceuticalMicrobiologyLaboratoriesTRS961Annex2.pdfGoodpracticesPharmaceuticalQualityControlLaboratoriesTRS957Annex1.pdfGuidelinesPreparingLaboratoryInformationFileTRS961Annex13.pdfModelCertificateAnalysisTRS902Annex10.pdfPrequalificationQualityControlLaboratoriesProcedureAssessingAcceptabilityUseUNAgenciesTRS961Annex12.pdfRecommendationsRiskTransmittingAnimalSpongiformEncephalopathyAgentsViaMedicinalProductsTRS908Annex1.pdf- Преквалификация
Annex3TRS-981.pdfAnnex4TRS-970.pdfAnnex4TRS-981.pdfGuidanceVariationSprequalifiedProductDossierTRS943Annex6.pdfGuidelinesOnRequalificationPrequalifiedTRS957Annex6.pdfGuidelinesSubmissionDocumentationPrequalificationInnovatorFinishedPharmProductsApprovedStringentRegulatoryAuthoritiesTRS961Annex11.pdfPrequalificationQualityControlLaboratoriesProcedureAssessingAcceptabilityTRS961Annex12.pdfTRS961_Annex10.pdfTRS986annex5.pdf- Производство
- GMP Annex3-TRS992.pdfGMPActivePharmaceuticalIngredientsTRS957Annex2.pdfGMPBiologicalProductsTRS822Annex3.pdfGMPBloodEstablishmentsTRS961Annex4.pdfGMPPharmaceuticalProductsCcontainingHhazardousSubstancesTRS957Annex3.pdfGMPRadiopharmaceuticalProductsTRS908Annex3.pdfGMPSterilePharmaceuticalProductsTRS961Annex6.pdfGMPWatePharmaceuticalUseTRS970Annex2.pdfInvestigationalPharmaceuticalProductsClinicalTrialsHumansTRS863Annex7.pdfSupplementaryGMPHeatingVentilationAirconditioningSystemsNonSterilePharmaceuticalDosageFormsTRS961Annex5.pdfSupplementaryGMPManufactureHerbalMedicinesTRS937Annex3.pdfSupplementaryGMPPharmaceuticalExcipientsTRS885Annex5.pdfSupplementaryGMPValidationTRS937Annex4.pdfTRS986annex2.pdf
- Анализ рисков
- Трансфер технологий
- Стабильность
- Взаимозаменяемость
- Q1 Изучение стабильности