The International Pharmacopeia Overview

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The International Pharmacopeia Overview Caroline Mendy Technical Officer - Quality Assurance and Safety: Medicines Quality of Active Pharmaceutical Ingredients, Beijing, March 2010

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The International Pharmacopeia – Ph. Int Scope WHO Expert Committee on Specifications for Pharmaceutical Preparations WHO consultative methodology 4 th Edition - APIs monographs elements What's new

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National/Regional Pharmacopeias Medicines for a particular market Legally restricting "official" Preparation by a national or provincial power

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The International Pharmacopeia A couple dates… The historical backdrop of the International Pharmacopeia goes back 1874… 1948 First World Health Assembly settled Expert Committee on Unification of Pharmacopeia 1950 WHA affirmed distribution of Pharmacopeia Internationalis (Ph.Int)

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The International Pharmacopeia Monographs and necessities for: Active Pharmaceutical Ingredients (APIs) Finished measurement frames General strategies/writings e.g. disintegration testing, tablets Completed with: General notification Supplementary data, e.g. General rules for Chemical Reference Substances Infrared reference spectra

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The International Pharmacopeia Scope since 1975 Model Lists of Essential Medicines Essential solutions are chosen with due respect to sickness commonness, prove on viability and wellbeing, and near cost-adequacy. Drugs suggested and details required by WHO Programs e.g. treatment rules for Malaria, TB, HIV/AIDS and for kids!

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The International Pharmacopeia execution: "prepared for use" by Member States "The Ph.Int [… ] is proposed to serve as source material for reference or adjustment by any WHO Member State wishing to build up pharmaceutical necessities. The pharmacopeia, or any piece of it, should have legitimate status, at whatever point a national or provincial power explicitly brings it into proper legislation." [Reference to World Health Assembly determination WHA3.10 , WHO Handbook of Resolutions and Decisions, Vol. 1, 1977, p. 127]

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How does the Ph.Int work? The Ph.Int depends on the work and choices of the WHO Expert Committee on Specifications for Pharmaceutical Preparations Aim in the course of the most recent 60 years: "to advance quality affirmation and quality control of pharmaceuticals"

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What is the WHO Expert Committee? Official Advisory Body to Director-General of WHO Governed through standards and strategies ( Ref . WHO Manual) Participation to Expert Committee (EC) gatherings: Voting individuals ("Experts") chose from WHO Panel of Experts Technical counsels Observers : - universal associations , -NGOs , -proficient affiliations…

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Outcome of the WHO Expert Committee? Report Summary of examinations Recommendations to WHO + Member States Presentation to WHO Governing Bodies for definite remarks, underwriting and usage by Member States  WHO specialized direction

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WHO Expert Committee Report Includes: Important redesign on the Ph.Int Proposed new work arrange Specifications for prescriptions (new received writings, corrections… ) Reference material (embraced International Chemical Reference Substances, Infrared Reference Spectra)

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WHO Consultative technique This procedure is intended to guarantee wide discussion and straightforwardness amid monograph improvement and to make the received writings accessible in an auspicious way.

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WHO takes the necessary steps … with Partners (1) Within WHO… WHO infection programs ( Stop TB, Roll-Back Malaria, HIV/AIDS, Tropical Neglected Diseases, programs on Children, Women's Health… ) Prequalification Program – A United Nations Program oversaw by WHO With Regulatory Bodies… National/Regional administrative powers Regional/Interregional administrative gatherings ( ASEAN, ICH... )

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WHO takes the necessary steps … with Partners (2) With Organizations and Associations… International associations ( UNAIDS, UNICEF, IAEA, World Bank… ) International expert and different affiliations , NGOs ( incl. industry, shopper affiliations: IFPMA-IGPA-WSMI, IPEC, FIP, WMA, MSF… ) With Standard-setting Bodies… Pharmacopeia Commissions and Secretariats (e.g. Brazilian, BP, IP, JP, Ph.Eur , Ch.P, USP , and PDG )

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WHO takes the necessary steps … with Partners (3) With "recognized" Experts… WHO Expert Panel on The International Pharmacopeia and Pharmaceutical Preparations (official selection handle) Specialists from all regions for particular activities (administrative, college, industry… ) With "recognized" Laboratories… National/Regional Quality control research facilities WHO Collaborating Centers (official assignment prepare)

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Scheme and connections WHO Expert Committee on Specifications for Pharmaceutical Preparations WHO needs Public request WHO Secretariat Partners Collaborating labs Industry

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WHO Procedure for the planning of medication Quality Control determinations (1) … ..or why it takes so long… . Step 1 : Identification of particular pharmaceutical items for which Quality Control (QC) determinations should be created, affirmation by all WHO parties concerned (counting Department of Essential Medicines and Pharmaceutical Policies (EMP) particular illness programs and the Prequalification Program) Step 2* : Provision of contact subtle elements from makers of the above items in a joint effort with all gatherings concerned Step 3* : Contact makers for arrangement of QC details and tests Step 4 : Identify and contact QC research centers for coordinated effort in the venture (2-3 labs relying upon what number of pharmaceutical items have been distinguished in step 1), Contract for lab work

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WHO Procedure for the planning of medication Quality Control details (2) … ..or why it takes so long… . Step 5 : Prepare the agreement for drafting the particulars and undertaking the fundamental research center work Step 6 : Search for data on QC details accessible in the general population area Step 7 : Laboratory testing , advancement and approval of QC Specifications Step 8 : Support WHO Collaborating Center in the foundation of International Chemical Reference Substances Step 9 : Follow the consultative procedure , mailing of draft determinations to Expert Panel and authorities

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WHO Procedure for the readiness of medication Quality Control details (3) … ..or why it takes so long… . Step 10 : Discussion of remarks with contract research centers, WHO Collaborating Centers, extra lab testing to confirm as well as approve details Step 11 : Consultation to talk about the remarks and test outcomes got as criticism Step 12 : distribution for remarks Step 13 : as step 10 Step 14 : Present the drafts to the WHO Expert Committee on Specifications for Pharmaceutical Preparations for conceivable formal appropriation , … if not embraced reiteration of steps 11 to 13 as regularly as essential

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WHO Procedure for the readiness of medication Quality Control determinations (4) … ..or why it takes so long… . … If embraced continue to step 15 Step 15 : Incorporate all progressions concurred amid the dialog prompting to selection together with any publication focuses. Where essential, likewise assess any further remarks that may in any case be gotten because of remark due dates for recycled writings (Step 12 and past) falling not long after the meeting. Step 16 : In all cases, affirm the altered content by correspondence with the applicable specialists or potentially contract research center before making it accessible on the WHO Medicines site. Step 17 : Make "final texts" accessible on the Medicines site to give clients, for example, PQ assessors and makers with the affirmed details ahead of time of the following distribution date.

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Manufacturer's association Dialog from the early phases of improvement of the draft monograph to the last content… Samples, Reference material Documentation Discussion on diagnostic issues when significant Comments on draft(s)

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Requirements for tests

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Requirements for details (1) Manufacturer's documentation is kept secret Description, Chemistry, Solubility, Storage, Labeling Definition, with data on polymorphism if important Identification Assay Specific tests (sulfated fiery debris, optical revolution, misfortune on drying… ) Related substances

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Requirements for determinations (2) Precise depiction of explanatory strategies Impurities (synthetic names, structures, source) Any applicable data on Performance testing (e.g. disintegration) Stability Validation of expository strategies

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Comments on drafts Different conceivable channels to speak with the Secretariat as remarks might be gotten straightforwardly from the makers via the universal producers affiliations (opportunity is then given to different makers to remark on drafts) ex: rundown of pollutions, Manufacture segment…

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The International Pharmacopeia current: 4 th Edition + 1 st Supplement Consolidated in 2 Volumes: -Vol. 1: pharmaceutical substances (An O) -Vol. 2: pharmaceutical substances (P-X) + dose frames + radiopharmaceuticals + techniques for investigation + reagents 1 st Supplement: new necessities and updates Available in Publication , CD-ROM and Online

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4 th Edition – (1) 4 th Edition Monographs on antiretrovirals (ARVs) Revision of existing monographs Improved presenta