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European Convention for the protection of vertebrate animals used for ... Pertussis vaccine (acellular): serological potency assay (same animals as for D&T vaccine) ...

No evidence for the presence of B19 genotypes 2 and 3 in Dutch blood donations ... Identification of two new unique' mutations in B19 genotype 1 isolates ...

EDQM: Recent developments Dr Claude Coune Head of the Publication and IT Department

Objective of Data Integrity What is Data Integrity? Regulatory Requirement Data Integrity Principles ALCOA, + Principles Basic Data Integrity Expectations Data Integrity examples and WL Implementation

Definition for Reference standard Requirements Guidelines Pharmacopiea Types of Reference Standards GMP- ICH Q7 SOP for handling of Reference Standards Qualification of Secondary Standards Assigning Potency, Storage and Use Documents & Records

Presented by: Isabel Chicharo MDMS Lead Data Officer Controlled Term Lists in use by eAF Container category; Country Quantity operator; Units of Measurement; MRL ...

We at Raaj GPRAC (Global Pharma Regulatory Affairs Consultants) in Thane, India offer pharma consulting, regulatory affairs services. We also conduct various workshops and seminars on pharma courses. Our Pharmaceutical Education arm conducts 6 months diploma courses in CTD/eCTD and regulatory affairs, also we conduct fast track pharma courses, distance learning programs for working professional and part time courses pertaining to Pharma and Biotech industry for students and working professionals.

GVK BIO offers long term Contract Manufacturing services right from strategic partnerships in development, validations, DMF filing and commercial manufacturing of Active Pharmaceutical Ingredients (APIs)/advanced intermediates to APIs.

Visit: http://sunilhealthcare.com/products/, Sunil Healthcare Limited is known as the India’s second largest EHG Capsules manufacturers in India and all over the world. We are the world’s best manufacturer of capsules with an annual production of 10.25 billion capsules in our fully automatic production lines. We are ISO and GMP certified unit for dealing in the array.

Are you obsessed with the benefits of Gelatin Capsules and looking for the hygienic products? Visit: http://sunilhealthcare.com, Sunil Healthcare Limited is the most renowned name in the array of manufacturing capsules in India and the international countries. To place an order, you can leave an enquiry or simply make a call.

Farmson is the pioneer and leading manufacturer of API Paracetamol / Acetaminophen based in India with a strong global presence and dominant position in the domestic market.

Title: The role of the European Pharmacopoeia in the standardisation of the quality of medicines in Europe Author: Szalai Last modified by: SE_EGYGYSZI

Visit: http://sunilhealthcare.com/products, Sunil Healthcare Limited, as one of the largest capsule manufacturer in India, offered you HPMC Capsules in a number of specifications that meet up your requirements at its best. You can tell your requirements by posting an email or sending enquires.

Title: Slide 1 Author: plamen peikov Last modified by: name1 Created Date: 6/16/2005 7:12:31 AM Document presentation format: On-screen Show Company

International Regulatory Cooperation on regulation. of herbal medicines 29 ... in order to facilitate the implementation of the Common Effective Preferential ...

Legislation, Registration and Control Procedures for Veterinary Medicinal Products in the European Union

Title: Universit degli Studi di Pavia Dip.to di Medicina Legale, Scienze Forensi e Farmaco-Tossicologiche Sezione di Scienze Farmacologiche e Tossicologiche Piazza ...

API manufacturer in third country. US willing to inspect AP1 AP2 and share the report with EU ... Abbreviations. EMEA- European Medicines Agency ...

(PHARMACEUTICALS EXPORT PROMOTION COUNCIL) Set up by Ministry of Commerce and Industry GOVERNMENT OF INDIA Export Opportunities for Pharma & Herbal Industry

Ceasing dependence on inspection means you must understand your processes so ... Ceasing dependence on inspection forces you to reduce variability.' Conclusion. 30 ...

* DRUG MASTER FILES- INTRODUCTION 1 DEFINITION- A Drug Master File (DMF) is a submission to the Regulatory Agencies of information, ... (CMC) of a drug product ...

Jarosz Regulatory Services, Inc (www.jrsweb.com) ... Use of preservatives. Type of packaging. Pack sizes. Sterilization process ...

CONTR LE DE QUALITE DES MEDICAMENTS Direction des laboratoires et des Contr les Pr. Pierre-Antoine BONNET Directeur scientifique Site Montpellier-Vendargues

CEP : Certificate of Suitability to the Monographs. of the European Pharmacopoeia, ... CEP. 1. 1993?? ??? ??. 2. '?????? ????'?? ??? ? ??? ?? ????? ...

Title: Slide 1 Author: scorrei2 Last modified by: pwalsh Created Date: 9/6/2006 5:39:08 PM Document presentation format: On-screen Show Company: Schering-Plough

PharmDev: Development of formulation/process, container-closure, compatibility, comparability ... Container-closure (FDA guideline) Sub-modules for diluents and ...

Quality Management for 21st Century S. Srinivasan CEO & Managing Director Matrix Laboratories Limited * Indian Pharmaceutical Companies geared up for global ...

Area between the two curves grows. Technology Curve (Pharma-Investment-Linked) ... to be reimbursed 100% (children, pregnant women, chronic diseases.) apprx. ...

... received from US FDA for Cephalexin API and Cefazolin sterile API; Australian ... Cephalexin capsules and Ceftriaxone Inj. ; more expected ...

Legislation, Registration and Control Procedures for Veterinary Medicinal Products in the European Union

SHOW CASING A.P. FAPCCI Seminar on Meeting Global Outsourcing Requirement PRESENTATION By DR.P.V.APPAJI M.Pharm, Ph.D EXECUTIVE DIRECTOR PHARMEXCIL

... Measures for prevention Article 18 ... Arial Trebuchet MS Verdana Times Times New Roman FOD_Volksgezondheid Slide 1 FAMHP Serialization : what good is it?

MA Application Dossier? ?? ??? ???. 2. MA ???? Format Change. From 1st July 2003, ... to generate and compile different registration dossiers for all three regions. ...

Requirements for manufacture. Manufacturing authorisation issued by national ... Inspection of manufacture. The European Medicines Regulatory Networking Model ...

UT, XUT, CORE, XCOR, CF, XCF, HR, XHR, ST and XST. ... You also have the option of searching UT, CORE, CF, HR and ST. appl data files. ...

extensor tendon injuries extensor tendon injuries extensor tendons are predisposed to laceration 1. due to superficial location on dorsum of hand 2.

CHMP Committee for Medicinal Products for Human Use ... All steps covering aseptic processing or sterilization to be validated ...

Help create effective legislative machinery to reduce the number of counterfeits ... of medicines prospects for the harmonisation of the Russian Pharmacopoeia with ...

The Role Of EMEA In Furthering The Development Of Innovative Products For Animal ... Novel indications e.g. improving clinical signs of anaemia ...

Bob Tribe Former Chairman of PIC/S Benefits of PIC/S Membership for the Philippines * * * * * * * * * * * * * * * * * * * World Health Organization ...

Montelukast sodium substantially free from sulfoxide and cis isomer' ... It has been brought to the attention of the IMB and other Health Authorities as ...

Case study on pyrogenicity. The long way to regulatory acceptance of ... Eppendorf-vial. 100 l fresh human whole blood (single/pool blood) 1000 l saline ...

Vision To be the global leader in pharmaceutical manufacturing by process ... market share with large volumes in ... which encompassed Indian ...

... in the mid-long term (brucellosis, tuberculosis, some antiparasitic vaccines... be responsible for monitoring progress and undertaking an annual review ...

... employs 3000 people across plants, research centre, field and ... Mn - Orchid continues to be one of the fastest growing pharmaceutical companies in India. ...

GLOBAL OPPORTUNITIES FOR HERBALS & ROLE OF PHARMEXCIL IN EXPORT PROMOTION ... Preparation of dossiers for submission to the regulatory affairs Payment of ...

European Association of Establishments for Veterinary Education Association Europenne des Etablissem

Serologicals enables the development of Life Science Products ... Life Science Research. Surgery involving tissue repair. Medical Device ...

Directives 2001/82/EC and 2001/83/EC. Articles 50(f) and 46(f) ... Increase in number of audits will lead to unmanageable burdens for AS manufacturers ...

F r die USP existiert ein Vorschlag f r die allgemeine Monographie 1226 ' ... Monographien, basierend auf validierten Dossiers, werden von mindestens 2 OMCL ...

see Annex I of Commission Directive 2003/63/EC of 25 June 2003, amending ... Section C of Annex I, and the various processes of dividing up, packaging or ...

Estamos en la era de la calidad, y es esta la que nos dar una ventaja ... Cuanta m s inversi n de tiempo, mayor calidad, ... Government of British Columbia ...

Deleted guinea pig test for diphtheria (residual toxin and irreversibility of diphtheria toxoid) ... Vaccination serological test in mice or guinea pigs ...

European Partnership for Alternative Approaches to ... Paediatrics. Orphans. 141/2000. Legal framework for medicinal products. Pharmaceutical legislation ...

5 mice and 2 guinea pigs. 20 to 30 fertilized eggs. No. No ... Neurovirulence (monovalent harvest): Monkey. Tg mice. OPV. Only on seeds. Only on first lots ...

Aarti Pharmalabs Ltd specializes in the clinical phase and commercial production of APIs and NCEs, intermediates, regulatory starting materials, key building blocks and xanthine derivatives. Our offerings include process R&D, analytical method development and validations, stability studies, scale-up and process optimization, process validations and commercial production. The quality and purity of our products have enabled us to be the leading Active Pharmaceutical ingredients manufacturers in India.