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The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines.

Standards are developed by the Committee through worldwide consultation and an international consensusbuilding process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource generic finished pharmaceutical product: quality part.

The World Health Organization was established in as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHOs constitutional functions is to provide objective and reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications.

The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world. To respond to the needs of Member States at all levels of development, WHO publishes practical manuals, handbooks and training material for specific categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and state-of-the-art consensus reports that offer technical advice and recommendations for decision-makers.

These books are closely tied to the Organizations priority activities, encompassing disease prevention and control, the development of equitable health systems based on primary health care, and health promotion for individuals and communities.

Progress towards better health for all also demands the global dissemination and exchange of information that draws on the knowledge and experience of all WHOs Member countries and the collaboration of world leaders in public health and the biomedical sciences.

To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its publications and encourages their translation and adaptation.

By helping to promote and protect health and prevent and control disease throughout the world, WHOs books contribute to achieving the Organizations principal objective the attainment by all people of the highest possible level of health. The WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects.

Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated policy of WHO. The International Pharmacopoeia, fourth edition. Volume 1: general notices; monographs for pharmaceutical substances AO Volume 2: monographs for pharmaceutical substances PZ ; monographs for dosage forms and radiopharmaceutical preparations; methods of analysis; reagents.

This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization. WHO technical report series ; no. Pharmaceutical preparations - standards. Technology, Pharmaceutical - standards. Drug industry - legislation.

Quality control. World Health Organization. World Health Organization All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.

Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.

Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication.

However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the policies of the World Health Organization.

Printed in Italy. General policy 2. Quality control specifications and tests 3. Quality control national laboratories 5. Prequalification of active pharmaceutical ingredients Prequalification of quality control laboratories Regulatory guidance Nomenclature, terminology and databases Annex 1 The International Pharmacopoeia Updating mechanism for the section on radiopharmaceuticals.

Annex 4 Assessment tool based on the model quality assurance system for procurement agencies: aidememoire forinspection. Annex 5 Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities. Annex 6 Guidelines on submission of documentation for a multisource generic finished pharmaceutical product: quality part. Kristensen, Vedbaek, Denmark Ms G.

Temporary advisers Dr M. Professor S. Bawazir had to leave urgently on 15 October. Hirschhorn, who was designated CoChairperson, took over the proceedings as Chairperson. Hirschhorn, who was designated Co-Chairperson, took over the proceedings as Chairperson from 15October as Professor S. Bawazir had to leave urgently on that date. Studer,4 Basel, Switzerland Dr J. Unable to attend. Torano, GlaxoSmithKline, England. Unable to attend: European Commission, Brussels, Belgium. Participated via audio connection for certain agenda items.

Schmidt, QSM Mr. Hagelstein Ms T. Burkard Intern. Bawazir, Dr L. Cargill, Dr A. Nasiri Kapour Chali, Professor T. Dekker, Dr X. Ge, Ms M. Hirschhorn, Professor J. Hoogmartens, Professor S. Jin, Dr B. Li, Dr L. Paleshnuik, Dr S. Parra, Dr J. Prakash, Ms L. Slamet and Dr J. Welink reported no conflict of interest. Professor J. Dressman reported that she was involved in a European Union EU research project partially related to biowaiver, under a grant issued to the University of Frankfurt, with no personal value.

Professor H. Kristensen reported that he has provided testimonies as an independent expert on questions on validity and for infringement of patients at courts in Denmark, Norway and Sweden. In all cases testimony is related to drug formulations. No items conflicted with the subjects of the meeting. Mahlangu reported that she would receive an out-of-pocket allowance from her current employer, the Medicines Control Authority of Zimbabwe, in accordance with the travel allowances schedule for sponsored travel.

The declarations of interest were presented to the Expert Committee for information. There were no comments from Committee members or advisers. Dr Kieny thanked the experts for their valuable contributions to the work of WHO, noting that standard-setting continues to be a pillar of WHO's activities and priorities and that the Expert Committee structure is the backbone of WHO's standardsetting process.

She stressed that the numerous and practical outputs emanating from the Expert Committee, developed as international guidelines and ready for implementation, enable countries to move forward towards their goals of universal health coverage, including access to safe quality medical products for their people. Referring to the ongoing WHO reform process, Dr Kieny pointed out that health systems including essential medicines and universal health coverage are one of the six priority categories of the Organization.

In addition one of WHOs leadership priorities is to increase access to essential high-quality and affordable medical products. She noted that the work of the Expert Committee had contributed in many ways to assisting national and regional authorities, including through development and guidance in the area of quality control laboratories, development of techniques for routine quality assurance and also in cases of suspect medicines.

The mechanism established an open-ended working group, which met in mid, to identify the actions, activities and behaviour that result in SSFFC medical products. She pointed out that that a number of activities outlined in the workplan of the Member State mechanism related to the Expert Committees agenda, including detection technologies, good practices in distribution for active pharmaceutical ingredients APIs , products and terminology used by this Expert Committee.

Participants were reminded that they participated in the meeting in their personal capacity as experts and not as representatives of their employing organizations. The meeting elected Professor S. Bawazir as Chairperson, Ms M. Hirschhorn as Co-Chairperson, and Dr S. Parra and Dr A. The process of guidelines development was explained. The open session of the meeting, held during the morning of Monday, 14 October , was opened by Mr C.

He stated that the open session had been organized to respond to the interest expressed by Member States during the meetings of the World Health Assembly and Executive Board, especially in connection with the quality of medicines, with a focus on prevention and control of SSFFC medical products. He noted that the aim of the session was to provide more information on this Expert Committee in an open and transparent manner.


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