Upload File

edqm conference certification procedure 1992-2012: 20 ...asmf. consequence: guideline will lead to...

  • Home
  • Documents
  • EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
27
EDQM Conference Certification Procedure 1992-2012: 20 Years of Experience Workshop 3 Quality of Antibiotics and Fermentation Products

Upload: others

Post on 30-Mar-2020

11 views

Category:

Documents


0 download

Report

TRANSCRIPT

Page 1: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs

EDQM Conference

Certification Procedure

1992-2012: 20 Years of Experience

Workshop 3

Quality of Antibiotics and Fermentation Products

Page 2: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 3: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 4: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 5: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 6: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 7: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 8: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 9: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 10: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 11: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 12: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 13: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 14: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 15: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 16: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 17: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 18: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 19: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 20: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 21: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 22: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 23: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 24: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 25: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 26: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs
Page 27: EDQM Conference Certification Procedure 1992-2012: 20 ...ASMF. Consequence: Guideline will lead to retrospective application for API manufacturer. -Limiting scope to only new APIs

The CombiStats User Manual - EDQM

Harmonised Technical Guidance for ASMF …esubmission.ema.europa.eu/eASMF/ASMF eCTD Guideline v2.0.pdfused (e.g. for responses to lists of questions). Please consult EMA Pre-submission

Guideline on ASMF Procedure - Draft V3

European Pharmacopoeia Reference Standards...THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE (EDQM) 2 ©2019 EDQM, Council of Europe. All rights …

ASMF eCTD Guideline - Europaesubmission.ema.europa.eu/eASMF/ASMF eCTD Guideline .pdfFor information on eCTD format requirements in CEP submissions please refer to EDQM. 2. General

ASMF Guidelines Rev3

IPA/EDQM/IPC Technical Conference - ipapharma.org - EDQM pdf/Nandkumar Chodankar-CT… · IPA/EDQM/IPC Technical Conference ... Only Specific File Formats are Allowed: PDF, SAS EXPORT,

EDQM SYMPOSIUM ON MICROBIOLOGY · EDQM SYMPOSIUM ON MICROBIOLOGY 10-11 October 2017 EDQM, ... microorganism ... Goverde,M.,VandenHeuvel,ER,

EDQM & European Pharmacopoeia: State-of-the-art Science ... · 3 ©2019 EDQM, Council of Europe. All rights reserved. … EDQM Conference in Tallinn 2016 Discussion focused on the

ASMF Procedure

EDQM Conference New technologies & their impact on … · EDQM Conference New technologies & their impact on the ... (i.e. during processing of critical quality and ... The ability

EDQM & European Pharmacopoeia: State-of-the-art Science ... · Nice to meet you ~10 Synthon CEPs ~15 Synthon ASMFs in the EU ASMF Worksharing procedure A lot of additional external

Pharmacopoeial Discussion Group Meeting EDQM · Meeting Highlights . May 25-26, 2016 . EDQM . Strasbourg, France . 1. Harmonisation Topics Signed-off 1.1. Excipients 1.1.1. New 1.1.1.1

The EDQM anti-counterfeiting Traceability service …...The EDQM anti-counterfeiting Traceability service for medicines GS1 Healthcare conference 1-3 April 2014, Seoul François-Xavier

Briefing Pack EDBC-EDQM

EDQM Workshop Bluetongue Vaccines · 1 EDQM Workshop Bluetongue Vaccines 19 February 2013 Strasbourg, France 19/02/13 ©2013 EDQM, Council of Europe. ... Efficacy of vaccination campaign

ASMF 01-00-2012- AP

THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE (EDQM) · 2019-10-14 · THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE (EDQM) 2 ©2019 EDQM,

ASMF Worksharing Procedure

API Inspections: the EDQM experience 29 March 2010 Florence Benoit-Guyod, EDQM Inspector Certification of substances Division, EDQM

ANNUAL REPORT 2010 - EDQM€¦ · 2010 also saw a strengthening of EDQM’s international collaboration. In May 2010, the EDQM took over responsibility for the establishment, production

CALL FOR TENDERS - EDQM

© AL IPA/EDQM/IDMA Symposium 2007, All rights reserved The Ph. Eur. policy on impurities Dr Andrea Lodi Deputy Head, Laboratory Department, EDQM, Council

Harmonised Technical Guidance for ASMF Submissions in …esubmission.ema.europa.eu/eASMF/ASMF eCTD Guideline v2.1.pdf · This guidance should be used in case submission in electronic

EDQM PAT Proceedings, 2004

EUROPEANPHARMACOPOEIA10.5 INDEX - EDQM

Gary Condran EDQM International Conference Bureau of ... · EDQM International Conference 19-20 September 2017 1 Gary Condran Associate Director Bureau of Pharmaceutical Sciences,

Information on the Certification Procedure Dr P. Poukens-Renwart Certification of Substances Division, EDQM P.Poukens-Renwart, 05/09/09 ©2009 EDQM, Council

Session 2 Different Approaches to BSM - EDQM · 1 EDQM SYMPOSIUM Blood Supply Management 1 October 2012 Strasbourg, France Session 2 Different Approaches to BSM

EDQM-AO-2020-Framework contract for the provision of

IGDRP Quality Working Group (WG) · IGDRP Quality Working Group (WG) 13th May, 2015 EDQM Strasbourg, FRANCE 1 The IGDRP Working groups have been identified. These are: • An ASMF/DMF

Technical Guide for the Elaboration of Monographs EDQM

Compilation of EDQM Non-Compliance Report Observations … · 2021. 1. 6. · Compilation of EDQM Non-Compliance Report Observations (2012-2015) ... Manipulation and falsification

What’s most recent in EDQM Inspections - EDQM pdf/Andrew McMath - EDQM... · What’s most recent in EDQM Inspections ? IPA-EDQM-IPC Technical Conference Mumbai, 28 – 29 January

ANNUAL REPORT 2011 - EDQM - European Directorate for … · European Pharmacopoeia state- ... United States Pharmacopoeia, ... In 2011, the EDQM organised and participated in a number