DOCUMENT RESOURCES FOR EVERYONE
Documents 1-2_SterilisationValidationQualification

Sterilization - validation, qualification requirements Mrs Robyn Isaacson 1 Manufacture of sterile medicines – Sterilization - Overview Objectives – Discuss definition…

Documents EU requirements for quality of APIs in Marketing Authorisation Application Latest developments...

Slide 1EU requirements for quality of APIs in Marketing Authorisation Application Latest developments Maryam MEHMANDOUST, PhD ANSM, France Current Challenges in Global Regulatory…

Documents EDQM Certification scheme: Common deficiencies observed in new chemical applications Dr...

Slide 1EDQM Certification scheme: Common deficiencies observed in new chemical applications Dr P.Poukens-Renwart Certification of Substances Division, EDQM & HealthCare…

Documents biological investigetional product

1 2 3 18 February 2010 EMA/CHMP/BWP/534898/2008 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on the Requirements for Quality Documentation Concerning…

Health & Medicine ICH Q8 " PHARMACEUTICAL DEVELOPMENT"

Slide 1 ICH GUIDELINES PRESENTED BY: DR. TALHA MAHMOOD BACKGROUND ICH established in 1990 as joint industry/ regulatory project to improve through harmonization the efficiency…

Documents ASEAN Guideline Stability FIX

5th Draft ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT Version 6.0 Update revision : May 2013 Document Control Version Date 1.0 July 2004 (8th ACSQ PPWG Meeting; Bangkok)…

Documents ASMF 01-00-2012- AP

Cambrex Profarmaco Milano S.r.l. EMTRICITABINE ACTIVE SUBSTANCE MASTER FILE Ed. 01.00/2012-ASMF NEW SUBMISSION OCTOBER 2012 Cambrex Profarmaco Milano S.r.l. Emtricitabine,…

Documents API Stability Lynda Paleshnuik Training workshop: Assessment of Interchangeable Multisource...

Slide 1API Stability Lynda Paleshnuik Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009 Slide 2 Assessment of Interchangeable Multisource…

Documents Introduction to WHO Prequalification of Medicines Programme Essential requirements Dr Milan Smid and...

Slide 1Introduction to WHO Prequalification of Medicines Programme Essential requirements Dr Milan Smid and many team colleagues WHO Prequalification of Medicines Programme…

Documents AJPTR Pharmaceutical Packaging Technology

REVIEW ARTICLE Am. J. PharmTech Res. 2012; 2(5) ISSN: 2249-3387 Please cite this article in press as: Thakkar A et al., Pharmaceutical Packaging Technology . American Journal…