HIER FINDEN SIE RELEVANTE GUIDELINES FÜR DIE WEITERBILDUNG UND CRASHKURSE.
| AMG |
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Arzneimittelgesetz (AMG) Deutschland - 06.05.2019 
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Arzneimittelgesetz (AMG) Österreich - 04.07.2019 
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Bundesgesetz über Arzneimittel und Medizinprodukte - 01.01.2019 
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| GMP für neuartige Therapien |
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| Leitlinien für die Gute Herstellungspraxis für Arzneimittel für neuartige Therapien - 22.11.2017
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Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products - 22.11.2017
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| GMP International |
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Bonnes Pratiques de Fabrication de Médicaments à Usage Humain I - III + Annexes - 2015
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Beşeri Tıbbi Ürünler İçin Temel Gereklilikler I - III + Ekler - 2015
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| GDP (+AM-HandelsV) |
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| Arzneimittelhandelsverordnung (AM-HandelsV) - 02.07.2018
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| Leitlinien für die gute Vertriebspraxis von Humanarzneimitteln - 05.11.2013
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| Guidelines on GDP of medicinal products for human use - 05.11.2013
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| Bonnes pratiques de distribution en gros - 05.11.2013
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| Leitlinien zu den Grundsätzen der guten Vertriebspraxis für Wirkstoffe von Humanarzneimitteln - 19.03.2015
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| Guidelines on principles of GDP of active substances for medicinal products for human use - 19.03.2015
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| GCP |
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| GCP-Verordnung (GCP-V) - 19.10.2012
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ICH E3 Structure and Content of Clinical Study Reports - 30.11.1995 
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| ICH E6 (R2) Good Clinical Practice - 09.11.2016
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| GLP (+ChemG) | |
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| Gesetz zum Schutz vor gefährlichen Stoffen (Chemikaliengesetz - ChemG) - 28.08.2013
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| OECD-Grundsätze der Guten Laborpraxis 22.04.1999
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| Verordnung (EG) Nr. 1907/2006 zur Registrierung, Bewertung, Zulassung und Beschränkung chemischer Stoffe (REACH) - 18.12.2006
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| Verordnung zum Schutz vor Gefahrstoffen (Gefahrstoffverordnung - GefStoffV) - 01.12.2010
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| EMA Guidelines | |
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| 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
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| CFR FDA Guidelines | |
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21 CFR Part 4 cGMP Requirements for Combination Products 
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| 21 CFR Part 11 Electronic Records, Electronic Signatures
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| 21 CFR Part 210 cGMP
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| 21 CFR Part 211 cGMP
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| 21 CFR Part 600 Biological Products
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| 21 CFR Part 800 Medical Devices
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| 21 CFR Part 820 Quality System Regulation
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| ICH: Quality |
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| ICH Q1A (R2) Stability testing of new drug substances and drug products - 06.02.2003
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| ICH Q1B Photostability testing of new active substances and medicinal products - 06.11.1996
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| ICH Q1C Stability testing requirements for new dosage forms - 06.11.1996
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| ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products - 07.02.2002
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| ICH Q1E Evaluation of stability data - 06.02.2003
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| ICH Q1F Stability data package for registration in climatic zones III and IV - 2018
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| ICH Q2 (R1) Validation of analytical procedures text and methodology - 01.11.2005
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| ICH Q3A (R2) Impurities in new drug substances - 25.10.2006
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| ICH Q3B (R2) Impurities in new drug products - 02.06.2006
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| ICH Q3C (R6) Residual solvents - 09.11.2016
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| ICH Q3C (R8) Residual solvents - 25.03.2020
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| ICH Q3D Elemental impurities - 22.03.2019
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| ICH Q4 Pharmacopoeias - 2001
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| ICH Q4A Pharmacopoeial Harmonisation - 2001
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| ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions 01.11.2007
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| 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
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| ICH Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products - 30.11.1995
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| ICH Q5C Stability testing of biotechnological/biological products - 30.11.1995
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| ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products - 16.07.1997
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| ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products - 18.11.2004
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| ICH Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances - 06.10.1999
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| ICH Q6B Specifications: test procedures and acceptance criteria for biotechnological/biological products - 10.03.1999
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| ICH Q7 Good manufacturing practice for active pharmaceutical ingredients - 10.11.2000
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| ICH Q8 (R2) Pharmaceutical development - 01.08.2009
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| ICH Q9 Quality Risk Management - 09.11.2005
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| ICH Q10 Note for Guidance on Pharmaceutical Quality System - 04.06.2008
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| ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) - 01.05.2012
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| ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management - 20.11.2019
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| ICH Q13 EWG - Continuous Manufacturing of Drug Substances and Drug Products - Business Plan - 15.11.2018
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| ICH Q13 EWG - Continuous Manufacturing of Drug Substances and Drug Products - Concept Paper - 15.11.2018
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| ICH Q13 EWG - Continuous Manufacturing of Drug Substances and Drug Products - Work Plan - 25.03.2020
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| ICH Q2(R2)/Q14 EWG - Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation - Business Plan - 15.11.2018
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| ICH Q2(R2)/Q14 EWG - Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation - Concept Paper - 15.11.2018
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| ICH Q2(R2)/Q14 EWG - Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation - Work Plan - 30.04.2020
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| WHO |
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| WHO good manufacturing practices for pharmaceutical products - 2011
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| WHO Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 2009
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| WHO Good Clinical Laboratory Practice - 2009
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