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Documents 1 API Assessment: Common Deficiencies Isabel Ortega and Antony Fake WHO Prequalification of...

Slide 11 API Assessment: Common Deficiencies Isabel Ortega and Antony Fake WHO Prequalification of Medicines Programme Assessors training, Copenhagen January 2012 Slide 2…

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Good Manufacturing PracticesPurpose and Principles of GMPTony Gould2 | PQ Workshop, Abu Dhabi | October 2010Why GMP?Provides a high level assurance that medicines are manufactured…

Health & Medicine 1 3 gmp-purpose-principles-guidelines

1. Good Manufacturing Practices Purpose and Principles of GMP 2. 2 | PQ Workshop, Abu Dhabi | October 2010 Why GMP? Provides a high level assurance that medicines are…

Documents 1 XXXXXXXXXXXXXXXXXXX, Malaysia, XXXXXX September, 2011 1 3.2.S.3.2 Impurities, Malaysia, 29...

Slide 1 1 XXXXXXXXXXXXXXXXXXX, Malaysia, XXXXXX September, 2011 1 3.2.S.3.2 Impurities, Malaysia, 29 September 2011 Options for submitting API data to support FPP prequalification…

Documents WHO Prequalification of Medicines Programme Raul Kiivet, MD, PhD Manager, Prequalification of...

Slide 1WHO Prequalification of Medicines Programme Raul Kiivet, MD, PhD Manager, Prequalification of Medicines Programme Quality Assurance and Safety: Medicines (QSM) Department…

Documents WHO Prequalification of Diagnostics – Tips for Success AIDS 2012 Satellite Session 25 July 2012,.....

Slide 1 WHO Prequalification of Diagnostics – Tips for Success AIDS 2012 Satellite Session 25 July 2012, Washington DC Gaby Vercauteren Diagnostics & Laboratory Technology…

Documents APPENDIX 6 Regulatory Control of API_30062014 (3)

1 APPENDIX 6: GUIDELINE ON REGULATORY CONTROL OF ACTIVE PHARMACEUTICAL INGREDIENTS (APIs) (Version 2.2) Outline: 1. Introduction 2. Definition 2.1 Definition of Active Pharmaceutical…

Documents API Assessment: Common Deficiencies

Slide 1 1 API Assessment: Common Deficiencies Isabel Ortega and Antony Fake WHO Prequalification of Medicines Programme Assessors training, Copenhagen January 2012 World…

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Generic Name : Physical Characteristics : Dosage Form : Product Dossier : Artemether & Lumefantrine Brand Name : Strength : 20 mg + 120 mg Pharmacopoeia : Therapeutic…