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Guidelines Quality Control
- Quality Control
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- General Requirements
- FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories, July 1993
- FDA Guidance for Industry: Investigating Out of Specification (OOS) results for Pharmaceutical Production
- FDA Guidance for Industry: PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites, April 1998
- EU GMP Annex 8: Sampling of Starting and Packaging Materials
- EU GMP Annex 19: Reference and Retention Samples
- Eudralex Volume 3 Radiopharmaceuticals Based on Monoclonal Antibodies (3AQ21A)
- Eudralex Volume 3 Specifications and control Tests on the Finished Product 3AQ11A
- Eudralex Volume 3 Guideline on the quality of water for pharmaceutical use
- ICH Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
- Eudralex Volume 3 ICH Topic Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
- ICH Q4B Annex 1 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter
- ICH 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
- ICH 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
- ICH Q4B Annex 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter Q4B Annex 5
- ICH Q4B Annex 6: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter
- ICH Q4B Annex 7(R2): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter
- Eudralex Volume 3 ICH Q4B Annex 9: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter
- Eudralex Volume 3 ICH Q4B Annex 10: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter
- Eudralex Volume 3 ICH Q4B Annex 11: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter
- Eudralex Volume 3 ICH Q4B Annex 12: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter
- ICH Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
- ICH Q5D Derivation and Characterisation of Cell Substrates Used For Production of Biotechnological/Biological Products
- ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
- ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Eudralex Volume 3 Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (ICH Q6A) CPMP/ICH/ 367/96-ICH Q6A
- ICH Q6A Attachments: Decision Trees #1 Through #8
- FIP Guidelines for Dissolution Testing of Solid Oral Products
- FDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997, Posed 8/25/1997)
- FDA Guidance for Industry: Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
- Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be forwarded in the Part II of the Dossier for a Marketing Authorisation
- Guideline on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for News Submissions and Variations
- FDA Guidance for Industry: Development and Submission of Near Infrared Analytical Procedures
- Concept Paper on Revision of the Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for new Submissions and Variations
- Guideline on the Investigation of Bioequivalence
- Recommendation on the Need for Revision of (CHMP) >Note for Guidance on Investigation of Bioavailability and Bioequivalence> CPMP/EWP/QWP/1401/98
- Guideline on Quality of Oral Modified Release Products
- Reflection paper on a proposed solution for dealing with minor deviations from the detail described in the Marketing Authorisation for Human and Veterinary Medicinal products (including biological products)
- PIC/S Aide Memoire on Inspection of Quality Control Laboratories(PI 023-2) Sept 2007
- PIC/S Guidance on Parametric Release (PIC/S PI 005-3)
- WHO General guidelines for the establishment, maintenance and distribution of chemical reference substances
- The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP)
- FDA Acceptability of Standards from Alternative Compendia (BP/EP/JP)
- FDA COMPLIANCE POLICY GUIDE Sec. 420.200 Compendium Revisions and Deletions (CPG 7132.02)
- FDA COMPLIANCE POLICY GUIDE Sec. 420.400 Performance of Tests for Compendial Requirements on Compendial Products (CPG 7132.05)
- FDA COMPLIANCE POLICY GUIDE Sec. 420.500 Interference with Compendial Tests (CPG 7132a.01)
- FDA Guidance for Industry: Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (Issued 11/19/2004, Posted 11/19/2004)
- FDA Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations
- FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products (Issued 5/1999, Posted 6/2/1999)
- WHO Basic tests for drugs : pharmaceutical substances, medicinal plant materials and dosage forms
- WHO The international Pharmacopoeia - related substances tests: dosage form monographs guidance notes
- WHO The International Pharmacopoeia
- WHO Index of national, regional and international pharmacopoeias
- WHO General guidelines for the establishment, maintenance and distribution of chemical reference substances
- WHO Considerations for requesting analyses of drug samples
- WHO Model certificate of analysis
- WHO Good practices for pharmaceutical quality control laboratories
- WHO Prequalification of quality control laboratories. Procedure for assessing the acceptability of quality control laboratories for use by United Nations agencies
- WHO Guidelines for preparing a laboratory information file
- WHO Quality control methods for medicinal plant materials
- FDA Guidance for Industry: The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)
- Impurities
- FDA Guidance for Industry: NDAs: Impurities in Drug Substances (Feb. 2000)
- FDA Guidance for Industry: ANDAs: Impurities in Drug Products
- FDA Guidance for Industry: ANDA's: Impurities in Drug Substances
- FDA Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States
- Impurities: Residual Solvents (CPMP/ICH/283/95)
- ICH Q3A(R2) Impurities in New Drug Substances
- ICH Q3B(R2) Impurities in New Drug Products
- Eudralex Volume 3 ICH guideline Q3C (R7) on impurities: guideline for residual solvents
- Eudralex 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
- ICH Q3D(R1) Guideline for Elemental Impurities
- Eudralex Volume 3 Implementation strategy of ICH Q3D guideline (Draft)
- Eudralex Volume 3 Implementation strategy of ICH Q3D guideline
- Eudralex Volume 3 Elemental impurities in marketed products. Recommendations for implementation
- ICH Q3C(R5) Impurities: Guideline for Residual Solvents - PDE for Cumene
- ICH Q3C(R6) Impurities: Guideline for Residual Solvents - PDE for Triethylamine and PDE of Methylisobutylketone
- ICH M7(R2) Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit potential carcinogenic risk
- Eudralex Volume 3 Guideline on the specification limits for residues of metal catalysts or metal reagents
- Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeial General Monograph "Substances for Pharmaceutical Use" and General Chapter" Control of Impurities in Substances for Pharmaceutical Use"
- WHO The international Pharmacopoeia - related substances tests: dosage form monographs guidance notes
- FDA Guidance for Industry: Testing of Glycerin for Diethylene Glycol
- Eudralex Volume 3 Guideline on setting specifications for related impurities in antibiotics
- Eudralex Volume 3 ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- Eudralex Volume 3 Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes
- Eudralex Volume 3 Questions and answers on the 'Guideline on the limits of genotoxic impurities'
- Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (ICH Topic S2 (R1)
- Eudralex Volume 3 Guideline on Control of Impurities of Pharmacopoeial Substances (CPMP/QWP/1529/04)
- Eudralex Volume 3 CPMP POSITION STATEMENT ON DNA AND HOST CELL PROTEINS (HCP) IMPURITIES, ROUTINE TESTING VERSUS VALIDATION STUDIES
- Eudralex Volume 3 Note for Guidance on Impurities Testing: Impurities in New Drug Substances (ICH Q3A (R2)) (CPMP/ICH/2737/99)
- Eudralex Volume 3 Note for Guidance on Impurities in new Drug Products (ICH Q3B(R2))(CPMP/ICH/2738/99)
- Stability
- ICH Q1A(R2) Stability Testing of new drugs and products (Revised guideline)
- ICH Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
- ICH Q1C Stability Testing: Requirements for New Dosage Forms
- ICH Q1D Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products
- Q1E Evaluation of Stability Data
- Eudralex Volume 3 Stability Data Package for Registration in Climatic Zones III and IV (ICH Q1F) CPMP/ICH/ 421/02-ICH Q1F
- ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
- Eudralex Volume 3 Evaluation of Stability Data (ICH Q1E) CPMP/ICH/ 420/02-ICH Q1E
- Eudralex Volume 3 Stability Testing of Existing Active Substances and Related Finished Products CPMP/QWP/ 122/02 Rev. 1 corr
- Eudralex Volume 3 Annex: Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances CPMP/QWP/ 609/96 Rev. 2
- Eudralex Volume 3 In-Use Stability Testing of Human Medicinal Products CPMP/QWP/2934/99
- Eudralex Volume 3 Maximum Shelf-Life for Sterile Products for Human Use after first opening or following Reconstitution CPMP/QWP/ 159/96 Corr.
- Eudralex Volume 3 Stability Testing for Applications for Variations to a Marketing Authorisation
- Eudralex Volume 3 Stability Testing of new Drug Substances and Products
- Eudralex Volume 3 Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products (ICH Q1D) CPMP/ICH/ 4104/00-ICH Q1D
- Eudralex Volume 3 Photostability Testing of New Active Substances and Medicinal Products (ICH Q1B) CPMP/ICH/279/95-ICH Q1B
- Eudralex Volume 3 Stability Testing: Requirements for New Dosage Forms (ICH Q1C) CPMP/ICH/ 280/95-ICH Q1C
- Human Drug cGMP Notes Second Quarter 2001
- Guideline on Stability Testing for Active and Medicinal Products Manufactured in Climatic Zones III and IV to be Marketed in the EU - Explanatory Note on the Withdrawal of ICH Q1F
- FDA COMPLIANCE POLICY GUIDE Sec. 480.100 Requirements for Expiration Dating and Stability Testing (CPG 7132a.04)
- FDA COMPLIANCE POLICY GUIDE Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs (CPG 7132b.11)
- FDA COMPLIANCE POLICY GUIDE Sec. 480.300 Lack of Expiration Date of Stability Data (CPG 7132a.10)
- FDA Guidance for Industry: Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
- FDA Guidance for Industry: Format and Content for the CMC Section of an Annual Report, 1994
- FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products
- FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products - Questions and Answers
- FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
- Drug Stability Guidelines
- WHO Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
- Pharmaceutical development
- Eudralex Volume 3 CONCEPT PAPER ON THE DEVELOPMENT OF A QUALITY GUIDELINE ON PHARMACEUTICAL DEVELOPMENT OF MEDICINES FOR PAEDIATRIC USE
- Eudralex Volume 3 ICH Topic Q 8 (R2)Pharmaceutical Development NOTE FOR GUIDANCE ON PHARMACEUTICAL DEVELOPMENT
- Eudralex Volume 3 ICH guideline Q8, Q9 and Q10 - questions and answers volume 4
- Eudralex Volume 3 Guideline on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/140/98 Rev. 1
- Eudralex Volume 3 NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE CPMP/EWP/QWP/1401/98
- Eudralex Volume 3 Note for Guidance on Development Pharmaceutics CPMP/QWP/155/96
- Analytical Validation
- ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology
- Eudralex Volume 3 Validation of Analytical Procedures: Text and Methodology (ICH Q2) CPMP/ICH/381/95 - ICH Q2 (R1)
- FDA Reviewer Guidance: Validation of Chromatographic Methods, 1994
- FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics
- Microbiology
- FDA Microbiological Guidelines
- FDA Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, July 1993
- FDA Guidance for Industry: Submission of Documentation in applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
- FDA Guidance for Industry: Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
- ICH Microbiological Documents
- ICH 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
- ICH 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
- ICH 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
- ICH Q4B Annex 8(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter
- PIC Documents
- EMA Documents
- Parametric Release CHMP/QWP/569959/2008
- Eudralex Volume 3 Guideline on Parametric Release
- Eudralex Volume 3 ICH Topic Q4B Annex 8 Sterility Test General Chapter
- Eudralex Volume 3 Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)
- Eudralex Volume 3 GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS
- Eudralex 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
- Eudralex Volume 3 GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS
- Eudralex 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
- Eudralex Volume 3 QUESTIONS AND ANSWERS ON BOVINE SPONGIFORM ENCEPHALOPATHIES (BSE) AND VACCINES
- Eudralex 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
- Eudralex Volume 3 CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products
- Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF MANUFACTURING PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS WITH REGARD TO VCJD RISK
- WHO Documents
- Process Analytical Technology (PAT)