MATERIALIEN FÜR IHRE WEITERBILDUNG

Guidelines

HIER FINDEN SIE RELEVANTE GUIDELINES FÜR DIE WEITERBILDUNG UND CRASHKURSE.

AMG
Arzneimittelgesetz (AMG) Deutschland - 06.05.2019 germany Flag
Arzneimittelgesetz (AMG) Österreich - 04.07.2019 austria Flag
Bundesgesetz über Arzneimittel und Medizinprodukte - 01.01.2019 swiss Flag
GMP Teil 1
Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV) - 02.07.2018 germany Flag
Leitfaden der Guten Herstellungspraxis Teil I – Arzneimittel - 01.03.2015 germany Flag
GMP Teil 2
Leitfaden der Guten Herstellungspraxis Teil II – Wirkstoffe - 01.09.2014 germany Flag
Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Part II - 01.09.2014 EU Flag
ICH Q7 Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients - 10.11.2000 british Flag
GMP Teil 3
Explanatory Notes on the preparation of a Site Master File - 2010 EU Flag
ICH Q9 Quality Risk Management - 01.09.2015 EU Flag
ICH Q10 Note for Guidance on Pharmaceutical Quality System - 01.09.2015 EU Flag
MRA Batch Certificate - 01.06.2011 EU Flag
Template for the written confirmation for active substances exported to the European Union for medicinal products for human use - 01.01.2013 EU Flag
GMP Anhänge
Annex 1 - Manufacture of Sterile Medicinal Products - 25.11.2008 EU Flag
Annex 2 - Manufacture of Biological active substances and Medicinal Products for Human Use - 26.06.2018 EU Flag
Annex 3 - Manufacture of Radiopharmaceuticals - 01.09.2008 EU Flag
Annex 4 - Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products - 2001 EU Flag
Annex 5 - Manufacture of Immunological Veterinary Medicinal Products - 2001 EU Flag
Annex 6 - Manufacture of Medicinal Gases - 03.02.2010 EU Flag
Annex 7 - Manufacture of Herbal Medicinal Products - 01.09.2008 EU Flag
Annex 8 - Sampling of Starting and Packaging Materials - 2001 EU Flag
Annex 9 - Manufacture of Liquids, Creams and Ointments - 2001 EU Flag
Annex 10 - Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation - 2001 EU Flag
Annex 11 - Computerised Systems - 2010 EU Flag
Annex 12 - Use of Ionising Radiation in the Manufacture of Medicinal Products - 2001 EU Flag
Annex 13 - Manufacture of Investigational Medicinal Products - 2010 EU Flag
Annex 14 - Manufacture of Products derived from Human Blood or Human Plasma - 2010 EU Flag
Annex 15 - Qualification and Validation - 30.03.2015 EU Flag
Annex 16 - Certification by a Qualified Person and Batch Release - 12.10.2015 EU Flag
Annex 17 - Parametric release - 26.12.2018 EU Flag
Annex 19 - Reference and Retention Samples - 14.12.2005 EU Flag
GMP requirements for Advanced Therapy Medicinal Products
Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products - 22.11.2017 EU Flag
GDP
Arzneimittelhandelsverordnung (AM-HandelsV) - 02.07.2018 germany Flag
Leitlinien für die gute Vertriebspraxis von Humanarzneimitteln - 05.11.2013 germany Flag
Leitlinien zu den Grundsätzen der guten Vertriebspraxis für Wirkstoffe von Humanarzneimitteln - 19.03.2015 germany Flag
GCP
GCP-Verordnung (GCP-V) - 19.10.2012 germany Flag
ICH E3 Structure and Content of Clinical Study Reports - 30.11.1995 british Flag
ICH E6 (R2) Good Clinical Practice - 09.11.2016 british Flag
GLP
Gesetz zum Schutz vor gefährlichen Stoffen (Chemikaliengesetz -ChemG) - 28.08.2013 germany Flag
OECD-Grundsätze der Guten Laborpraxis 22.04.1999 germany Flag
Verordnung (EG) Nr. 1907/2006 zur Registrierung, Bewertung, Zulassung und Beschränkung chemischer Stoffe (REACH) - 18.12.2006 germany Flag
Verordnung zum Schutz vor Gefahrstoffen (Gefahrstoffverordnung - GefStoffV) - 01.12.2010 germany Flag
EMA Guidelines
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - 20.11.2014 EU Flag
CFR FDA Guidelines
21 CFR Part 4 cGMP Requirements for Combination Products usa Flag
21 CFR Part 11 Electronic Records, Electronic Signatures usa Flag
21 CFR Part 210 cGMP usa Flag
21 CFR Part 211 cGMP usa Flag
21 CFR Part 600 Biological Products usa Flag
21 CFR Part 800 Medical Devices usa Flag
21 CFR Part 820 Quality System Regulation usa Flag
ICH: Quality
ICH Q1A (R2) Stability testing of new drug substances and drug products - 06.02.2003 british Flag
ICH Q1B Photostability testing of new active substances and medicinal products - 06.11.1996 british Flag
ICH Q1C Stability testing requirements for new dosage forms - 06.11.1996 british Flag
ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products - 07.02.2002 british Flag
ICH Q1E Evaluation of stability data - 06.02.2003 british Flag
ICH Q1F Stability data package for registration in climatic zones III and IV - 2018 british Flag
ICH Q2 (R1) Validation of analytical procedures text and methodology - 01.11.2005 british Flag
ICH Q3A (R2) Impurities in new drug substances - 25.10.2006 british Flag
ICH Q3B (R2) Impurities in new drug products - 02.06.2006 british Flag
ICH Q3C (R6) Residual solvents - 09.11.2016 british Flag
ICH Q3C (R8) Residual solvents - 25.03.2020 british Flag
ICH Q3D Elemental impurities - 22.03.2019 british Flag
ICH Q4 Pharmacopoeias - 2001 british Flag
ICH Q4A Pharmacopoeial Harmonisation - 2001 british Flag
ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions 01.11.2007 british Flag
ICH Q5A (R1) Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - 23.09.1999 british Flag
ICH Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products - 30.11.1995 british Flag
ICH Q5C Stability testing of biotechnological/biological products - 30.11.1995 british Flag
ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products - 16.07.1997 british Flag
ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products - 18.11.2004 british Flag
ICH Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances - 06.10.1999 british Flag
ICH Q6B Specifications: test procedures and acceptance criteria for biotechnological/biological products - 10.03.1999 british Flag
ICH Q7 Good manufacturing practice for active pharmaceutical ingredients - 10.11.2000 british Flag
ICH Q8 (R2) Pharmaceutical development - 01.08.2009 british Flag
ICH Q9 Quality Risk Management - 09.11.2005 british Flag
ICH Q10 Note for Guidance on Pharmaceutical Quality System - 04.06.2008 british Flag
ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) - 01.05.2012 british Flag
ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management - 20.11.2019 british Flag
ICH Q13 EWG - Continuous Manufacturing of Drug Substances and Drug Products - Business Plan - 15.11.2018 british Flag
ICH Q13 EWG - Continuous Manufacturing of Drug Substances and Drug Products - Concept Paper - 15.11.2018 british Flag
ICH Q13 EWG - Continuous Manufacturing of Drug Substances and Drug Products - Work Plan - 25.03.2020 british Flag
ICH Q2(R2)/Q14 EWG - Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation - Business Plan - 15.11.2018 british Flag
ICH Q2(R2)/Q14 EWG - Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation - Concept Paper - 15.11.2018 british Flag
ICH Q2(R2)/Q14 EWG - Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation - Work Plan - 30.04.2020 british Flag
WHO
WHO good manufacturing practices for pharmaceutical products - 2011 british Flag
WHO Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 2009 british Flag
WHO Good Clinical Laboratory Practice - 2009 british Flag

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