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2938FDA Guidance for Reviewers Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
2939FDA Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications
2941FDA Guidance for Industry Providing Regulatory Submissions to CBER in Electronic Format — Investigational New Drug Applications (INDs)
2942FDA Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees
2943FDA Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information
2944FDA Guidance for Industry Acceptance of Foreign Clinical Studies
2945FDA Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds
2946FDA Guidance for Industry Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
2947FDA Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products
2949FDA Guidance for Industry Submission of Abbreviated Reports and Synopses in Support of Marketing Applications
2951FDA Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products
2952FDA INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE M4: COMMON TECHNICAL DOCUMENT MODULES IIA, IIB NONCLINICAL MODULE III, QUALITY MODULES IV, NONCLINICAL MODULE V, EFFICACY
2953FDA International Conference on Harmonisation; Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability
2954FDA International Conference on Harmonisation; Guidance on Statistical Principles for Clinical Trials; Availability
2955FDA International Conference on Harmonisation; Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data; Availability
2970FDA Q10 PHARMACEUTICAL QUALITY SYSTEM
3081Eudralex Volume 9 2001/82/EC on the Community code relating to veterinary medicinal products
3082Eudralex Volume 9 Volume 9b - Pharmacovigilance for Medicinal Products for Veterinary Use
3097Change Control Process for European eSubmission Standards - v2.1 (May 2011)
3099Eudralex Volume 2C CMDh BEST PRACTICE GUIDE ON THE PROCESSING OF RENEWALS IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES
3100Eudralex Volume 2C Guideline on the “2nd step”, when the Competent Authority has to take into account the effect of the PMF/VAMF certification on the concerned medicinal product(s).
3101Eudralex Volume 2C Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7): Annex
3116FDA Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
3117Eudralex Volume 3 GUIDELINE ON PRODUCTION AND QUALITY OF MONOCLONAL ANTIBODIES AND RELATED SUBSTANCES
3118Eudralex Volume 3 GUIDELINE ON POTENCY TESTING OF CELL BASED IMMUNOTHERAPY MEDICINAL PRODUCTS FOR THE TREATMENT OF CANCER
3119Eudralex Volume 3 GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS
3120Eudralex Volume 3 GUIDELINE ON DEVELOPMENT AND MANUFACTURE OF LENTIVIRAL VECTORS
3121Eudralex Volume 3 NOTE FOR GUIDANCE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE
3123Eudralex Volume 3 NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF GENE TRANSFER MEDICINAL PRODUCTS
3124Eudralex Volume 3 NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
3125Eudralex Volume 3 CPMP POSITION STATEMENT ON DNA AND HOST CELL PROTEINS (HCP) IMPURITIES, ROUTINE TESTING VERSUS VALIDATION STUDIES
3128Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY
3131Eudralex Volume 3 USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE
3132Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF CYTOKINE PRODUCTS DERIVED BY BIOTECHNOLOGICAL PROCESSES
3133Eudralex Volume 3 NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96)
3134Eudralex Volume 3 TESTS ON SAMPLES OF BIOLOGICAL ORIGIN
3135Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES
3136Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS
3137Eudralex Volume 3 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS
3139Eudralex Volume 3 NOTE FOR GUIDANCE ON PLASMA-DERIVED MEDICINAL PRODUCTS
3140Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1
3141Eudralex Volume 3 ANNEXES TO GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1
3142Eudralex Volume 3 GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF ANTIBODY TO HUMAN IMMUNODEFICIENCY VIRUS (ANTI-HIV) IN PLASMA POOLS
3143Eudralex Volume 3 GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) IN PLASMA POOLS
3145Eudralex Volume 3 GUIDELINE ON THE REQUIREMENTS FOR PLASMA MASTER FILE (PMF) CERTIFICATION
3146Eudralex Volume 3 GUIDELINE ON ASSESSING THE RISK FOR VIRUS TRANSMISSION – NEW CHAPTER 6 OF THE NOTE FOR GUIDANCE ON PLASMADERIVED MEDICINAL PRODUCTS
3147Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF MANUFACTURING PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS WITH REGARD TO VCJD RISK
3149Eudralex Volume 3 CPMP POSITION STATEMENT ON WEST NILE VIRUS AND PLASMA-DERIVED MEDICINAL PRODUCTS
3150Eudralex Volume 3 CPMP POSITION STATEMENT NON-REMUNERATED AND REMUNERATED DONORS: SAFETY AND SUPPLY OF PLASMA-DERIVED MEDICINAL PRODUCTS
3151Eudralex Volume 3 PLASMA-DERIVED MEDICINAL PRODUCTS: POSITION PAPER ON ALT TESTING
3152Eudralex Volume 3 GUIDELINE ON DOSSIER STRUCTURE AND CONTENT OF MARKETING AUTHORISATION APPLICATIONS FOR INFLUENZA VACCINES DERIVED FROM STRAINS WITH A PANDEMIC POTENTIAL FOR USE OUTSIDE OF THE CORE DOSSIER CONTEXT
3153Eudralex Volume 3 GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE
3154Eudralex Volume 3 EXPLANATORY NOTE ON IMMUNOMODULATORS FOR THE GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE
3155Eudralex Volume 3 GUIDELINE ON DOSSIER STRUCTURE AND CONTENT FOR PANDEMIC INFLUENZA VACCINE MARKETING AUTHORISATION APPLICATION
3156Eudralex Volume 3 GUIDELINE ON SUBMISSION OF MARKETING AUTHORISATION APPLICATIONS FOR PANDEMIC INFLUENZA VACCINES THROUGH THE CENTRALISED PROCEDURE
3157Eudralex Volume 3 GUIDELINE ON REQUIREMENTS FOR VACCINE ANTIGEN MASTER FILE (VAMF) CERTIFICATION
3158Eudralex Volume 3 CPMP POSITION STATEMENT ON THE QUALITY OF WATER USED IN THE PRODUCTION OF VACCINES FOR PARENTERAL USE
3159Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A VACCINE ANTIGEN MASTER FILE (VAMF)
3160Eudralex Volume 3 CELL CULTURE INACTIVATED INFLUENZA VACCINES ANNEX TO NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES (CPMP/BWP/214/96)
3161Eudralex Volume 3 POINTS TO CONSIDER ON THE DEVELOPMENT OF LIVE ATTENUATED INFLUENZA VACCINES
3162Eudralex Volume 3 NOTE FOR GUIDANCE ON THE DEVELOPMENT OF VACCINA VIRUS BASED VACCINES AGAINST SMALLPOX
3163Eudralex Volume 3 POINTS TO CONSIDER ON THE REDUCTION, ELIMINATION OR SUBSTITUTION OF THIOMERSAL IN VACCINES
3164Eudralex Volume 3 Public Statement on the Evaluation of Bovine Spongiform Encephalopathies (BSE)-risk via the use of materials of bovine origin in or during the manufacture of vaccines
3165Eudralex Volume 3 NOTE FOR GUIDANCE ON PHARMACEUTICAL AND BIOLOGICAL ASPECTS OF COMBINED VACCINES
3166Eudralex Volume 3 NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES
3167Eudralex Volume 3 QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/ BIOLOGICAL PRODUCTS
3168Eudralex Volume 2C Guidance on a new therapeutic indication for a well established substance (November 2007)
3169Eudralex Volume 3 DEVELOPMENT PHARMACEUTICS FOR BIOTECHNOLOGICAL AND BIOLOGICAL PRODUCTS (CPMP/BWP/328/99) ANNEX TO NOTE FOR GUIDANCE ON DEVELOPMENT PHARMACEUTICS (CPMP/QWP/155/96)
3170Eudralex Volume 3 GUIDELINE ON POTENCY LABELLING FOR INSULIN ANALOGUE CONTAINING PRODUCTS WITH PARTICULAR REFERENCE TO THE USE OF “INTERNATIONAL UNITS” OR “UNITS”
3171Eudralex Volume 2C Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period (November 2007)
3172Eudralex Volume 3 CORE SPC FOR PANDEMIC INFLUENZA VACCINES
3173GUIDELINE ON PHARMACEUTICAL ASPECTS OF THE PRODUCT INFORMATION FOR HUMAN VACCINES
3174Eudralex Volume 3 NOTE FOR GUIDANCE ON THE WARNING ON TRANSMISSIBLE AGENTS IN SUMMARY OF PRODUCT CHARACTERISTICS (SPCs) AND PACKAGE LEAFLETS FOR PLASMA-DERIVED MEDICINAL PRODUCTS
3175Eudralex Volume 3 GUIDANCE ON THE DESCRIPTION OF COMPOSITION OF PEGYLATED (CONJGATED) PROTEINS IN THE SPC
3176Eudralex Volume 3 GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS
3177Eudralex Volume 3 NOTE FOR GUIDANCE ON THE USE OF BOVINE SERUM IN THE MANUFACTURE OF HUMAN BIOLOGICAL MEDICINAL PRODUCTS
3178Eudralex Volume 3 POSITION PAPER ON VIRAL SAFETY OF ORAL POLIOVIRUS VACCINE (OPV)
3179Eudralex Volume 3 NOTE FOR GUIDANCE ON Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
3180Eudralex Volume 3 NOTE FOR GUIDANCE ON VIRUS VALIDATION STUDIES: THE DESIGN, CONTRIBUTION AND INTERPRETATION OF STUDIES VALIDATING THE INACTIVATION AND REMOVAL OF VIRUSES
3181Eudralex Volume 3 FIRST CASES OF BSE IN USA AND CANADA: RISK ASSESSMENT OF RUMINANT MATERIALS ORIGINATING FROM USA AND CANADA
3182Eudralex Volume 3 NOTE FOR GUIDANCE ON GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS AMENDMENTS TO SECTIONS 6.2 AND 6.3
3183Eudralex Volume 3 NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS (EMEA/410/01 REV. 3) (2011/C 73/01)
3184Eudralex Volume 3 POSITION PAPER ON RE-ESTABLISHMENT OF WORKING SEEDS AND WORKING CELL BANKS USING TSE COMPLIANT MATERIALS
3185Eudralex Volume 3 PUBLIC REPORT RISK AND REGULATORY ASSESSMENT OF LACTOSE AND OTHER PRODUCTS PREPARED USING CALF RENNET
3186Eudralex Volume 3 JOINT CPMP/CVMP NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS - EXPLANATORY NOTE FOR MEDICINAL PRODUCTS FOR HUMAN USE IN THE SCOPE OF THE GUIDELINE
3187Eudralex Volume 3 QUESTIONS AND ANSWERS ON BOVINE SPONGIFORM ENCEPHALOPATHIES (BSE) AND VACCINES
3188Eudralex Volume 3 PUBLIC STATEMENT ON THE EVLAUATION OF SPONGIFORM ENCEPHALOPATHIES (BSE)-RISK VIA THE USE OF MATERIALS OF BOVINE ORIGIN IN OR DURING THE MANUFACTURE OF VACCINES
3189Eudralex Volume 3 GELATIN FOR USE IN PHARMACEUTICALS: EXPLANATORY NOTE (13 DECEMBER 2000) ON THE MANUFACTURE OF GELATIN IN RELATIONSHIP TO THE CPMP NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPAHTY AGENTS VIA MEDICINAL PRODUCTS (CPMP/BWP/1230/98 REV 1)
3190Eudralex Volume 3 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION STATEMENT ON POLYSORBATE 80
3191Eudralex Volume 3 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION PAPER ON PRODUCTION OF TALLOW DERIVATIVES FOR USE IN PHARMACEUTICALS
3192Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF MANUFACTURING PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS WITH REGARD TO VCJD RISK
3193Eudralex Volume 3 Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products
3194Eudralex Volume 3 GUIDELINE ON ENVIRONMENTAL RISK ASSESSMENTS FOR MEDICINAL PRODUCTS CONSISTING OF, OR CONTAINING, GENETICALLY MODIFIED ORGANISMS (GMOs)
3195EU GMP Inspection report - Community format
3196FDA Guidance for Industry Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
3197FDA Guidance for Industry “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV
3198FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility DRAFT GUIDANCE
3199FDA Guidance for Industry Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes
3200FDA Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
3201FDA Guidance for Industry and FDA Review Staff Collection of Platelets by Automated Methods
3203FDA Guidance for Industry Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
3204FDA FEDERAL REGISTER 21 CFR Part 866 [Docket No. 2007N–0294] Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay
3205FDA Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
3207FDA Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions
3208FDA Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
3209FDA FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule
3212FDA Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide
3213FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
3214FDA FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule
3215FDA Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
3236NOTICE TO APPLICANTS Volume 6C GUIDELINE ON THE PACKAGING INFORMATION OF VETERINARY MEDICINAL PRODUCTS AUTHORISED BY THE COMMUNITY
3238FDA Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
3240FDA Marketed Unapproved Drugs
3241FDA PET Drug Products - CGMP / Small Entities
3242FDA Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
3285Eudralex Volume 10 Guidance for the communication on GCP inspections and findings
3287Eudralex Volume 10 Annex I TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Investigator site
3288Eudralex Volume 10 Annex II TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Clinical Laboratories
3289Eudralex Volume 10 Annex III TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Computer Systems
3290Eudralex Volume 10 Annex IV TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Sponsor and CRO
3291Eudralex Volume 10 Guidance for the preparation of GCP inspections
3292Eudralex Volume 10 Guidance for the preparation of Good Clinical Practice inspection reports
3293Eudralex Volume 10 Guideline 2008/C168/02 on the data fields from the European clinical trials database (EudraCT) that may be included in the European database on Medicinal Products
3295FDA Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
3296FDA Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 1 Residue on Ignition/Sulphated Ash General Chapter
3298FDA Indexing Structured Product Labeling
3299FDA Current Good Manufacturing Practice for Phase 1 Investigational Drugs
3300FDA Submission of Documentation in applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
3301FDA Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
3302FDA Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter
3303FDA Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
3304FDA Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 5: Disintegration Test General Chapter
3306Eudralex Volume 3 Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants)
3310ICH Q4B Annex 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter Q4B Annex 5
3325FDA COMPLIANCE POLICY GUIDE Sec. 410.100 Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations (CPG 7132a.06)
3326Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
3327Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
3331Annex 1 - Contract between Auditor and the API Compliance Institute
3332Annex 2 - Agreement on Audit Execution
3333Annex 3 - Secrecy Agreement
3335Standardised Letters related to Shared 3rd Party Audits: Letter 1 - Letter to the Manufacturing Authorisation Holder
3336Standardised Letters related to Shared 3rd Party Audits: Letter 2 - Letter to the API Manufacturer
3337Standardised Letters related to Shared 3rd Party Audits: Letter 3 - Letter from the API Manufacturer to the customer
3338Annex 5 - Feedback Form
3339APIC - Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers - Integrating GMP (ICH Q7a) into ISO (9001:2000), September 2005
3350FDA Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
3353FDA Process Validation: General Principles and Practices
3356Eudralex Volume 10 Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units
3357Eudralex Volume 10 Annex VII TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials
3358Eudralex Volume 10 Recommendation on inspection procedures for the verification of good clinical practice compliance
3359Eudralex Volume 10 Procedure for standardisation of GCP inspection entries in EudraCT
3360Eudralex Volume 10 Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice
3361Eudralex Volume 10 Guidelines on good clinical practice (ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95)
3375FDA Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information
3376FDA Residual Solvents in Drug Products Marketed in the United States
3377FDA Q8(R2) Pharmaceutical Development Revision 2
3382EU GMP Annex 11: Computerised Systems
3384EU GMP Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
3386FDA Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review
3399ICH Q4B Annex 2(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter
3400ICH Q4B Annex 3(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter
3401ICH Q4B Annex 4A(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
3402ICH Q4B Annex 4B(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter
3403ICH Q4B Annex 4C(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
3404ICH Q4B Annex 6: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter
3405ICH Q4B Annex 7(R2): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter
3406ICH Q4B Annex 8(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter
3407FDA Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - General
3408FDA Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Equipment
3409FDA Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Control of Components and Drug Product Containers and Closures
3410Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Packaging and Labeling Control
3411FDA Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Laboratory Controls
3412FDA Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Records and Reports
3413FDA Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Production and Process Control
3426Eudralex Volume 3 Guideline on Active Substance Master File Procedure
3427Eudralex Volume 3 Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier (CHMP/QWP/297/97 Rev. 1)
3428Guideline on Active Substance Master File Procedure (CPMP/QWP/227/02 Rev. 1)
3429Eudralex Volume 3 Guideline on the Chemistry of New Active Substances (CPMP/QWP/130/96 Rev. 1)
3430Eudralex Volume 3 Investigation of Chiral Active Substances (3CC29A)
3431Eudralex Volume 3 Chemistry of Active Substances (3AQ5A)
3435Eudralex Volume 3 Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products (CPMP/QWP/159/01)
3436Eudralex Volume 3 Note for Guidance on Manufacture of the Finished Dosage Form (CPMP/QWP/486/95)
3437Eudralex Volume 3 Annex to Note for Guidance on Manufacture of the finished dosage Form: Start of Shelf-Life of the Finished Dosage Form (CPMP/QWP/072/96)
3438Eudralex Volume 3 The use of Ionizing Radiation in the Manufacture of Medicinal Products 3AQ4A
3440Eudralex Volume 3 Guideline on the Limits of genotoxic impurities (CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006)
3441Eudralex Volume 3 Guideline on Control of Impurities of Pharmacopoeial Substances (CPMP/QWP/1529/04)
3442Eudralex Volume 3 Note for Guidance on Impurities in new Drug Products (ICH Q3B(R2))(CPMP/ICH/2738/99)
3443Eudralex Volume 3 Note for Guidance on Impurities Testing: Impurities in New Drug Substances (ICH Q3A (R2)) (CPMP/ICH/2737/99)
3444Eudralex Volume 3 ICH Topic Q3C (R5) Impurities: Guideline for residual solvents
3445Eudralex Volume 3 Annexes to: CPMP/ICH/283/95 Impurities: Guideline for Residual Solvents & CVMP/VICH/502/99 Guideline on Impurities: Residual Solvents; ANNEX I: SPECIFICATIONS FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS IN ACTIVE SUBSTANCES; ANNEX II: RESIDUES OF SOLVENTS USED IN THE MANUFACTURE OF FINISHED PRODUCTS
3447Eudralex Volume 3 Guideline on setting specifications for related impurities in antibiotics EMA/CHMP/CVMP/QWP/199250/2009
3448Eudralex Volume 3 ICH Topic Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
3449ICH Q4B Annex 1 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter
3450Eudralex Volume 3 ICH Topic Q4B Annex 2 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter
3451Eudralex Volume 3 ICH Topic Q4B Annex 3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter
3452Eudralex Volume 3 ICH Topic Q4B Annex 4 A Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
3453Eudralex Volume 3 ICH Topic Q4B Annex 4 B Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter
3454Eudralex Volume 3 ICH Topic Q4B Annex 4 C Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
3455Eudralex Volume 3 ICH Topic Q4B Annex 5 Disintegration Test General Chapter
3456Eudralex Volume 3 Guideline on the use of Near Infrared Spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations

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