WHO Technical Report Series, No. 957 - Multiple Choices - World ...

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WHO Library Cataloguing-in-Publication Data:Forty-fourth report of the WHO Expert Committee on specifi cations for pharmaceuticalpreparations.(WHO technical report series; no. 957)1. Pharmaceutical preparations — standards. 2. Technology, Pharmaceuticals — standards.3. Drug industry — legislation. 4. Quality control. I. World Health Organization. II. Series.ISBN 978 92 4 120957 1 (NLM classifi cation: QV 771)ISSN 0512-3054© World Health Organization 2010All rights reserved. Publications of the World Health Organization can be obtained fromWHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland(tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requestsfor permission to reproduce or translate WHO publications—whether for sale or fornoncommercial distribution—should be addressed to WHO Press, at the above address(fax: +41 22 791 4806; e-mail: permissions@who.int).The designations employed and the presentation of the material in this publication do notimply the expression of any opinion whatsoever on the part of the World Health Organizationconcerning the legal status of any country, territory, city or area or of its authorities, orconcerning the delimitation of its frontiers or boundaries. Dotted lines on maps representapproximate border lines for which there may not yet be full agreement.The mention of specifi c companies or of certain manufacturers’ products does not implythat they are endorsed or recommended by the World Health Organization in preference toothers of a similar nature that are not mentioned. Errors and omissions excepted, the namesof proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by the World Health Organization to verifythe information contained in this publication. However the published material is beingdistributed without warranty of any kind, either expressed or implied. The responsibility forthe interpretation and use of the material lies with the reader. In no event shall the WorldHealth Organization be liable for damages arising from its use.This publication contains the collective views of an international group of experts and doesnot necessarily represent the decisions or the stated policy of the World Health Organization.Typeset in SwitzerlandPrinted in Switzerlandii
Contents1. Introduction 12. General policy 32.1 International collaboration 32.1.1 International organizations, agencies andnongovernmental organizations 3European Directorate for the Quality of Medicinesand HealthCare 3European Medicines Agency 4The Global Fund to Fight AIDS, Tuberculosis and Malaria 4Groupement International de la RépartitionPharmaceutique — European Associationof Pharmaceutical Full-line Wholesalers 4International Federation of PharmaceuticalManufacturers and Associations 5International Generic Pharmaceutical Alliance 5International Pharmaceutical Federation 6United Nations Children’s Fund 62.1.2 Pharmacopoeial Discussion Group 72.1.3 International Conference on Harmonisation 82.1.4 International Conference of Drug Regulatory Authorities 82.2 Cross-cutting issues in pharmaceuticals — qualityassurance issues 92.2.1 Herbal medicines 92.2.2 Biologicals and vaccines 102.2.3 Blood products 112.2.4 Essential medicines 112.2.5 Regulatory support 132.2.6 HIV-related activities 142.3 Counterfeit medicines 143. Quality control — specifications and tests 163.1 The International Pharmacopoeia 163.2 Current work plan and future work programme 193.3 Specifi cations for medicines, including children’s medicines 233.3.1 Medicines for HIV and related conditions 233.3.2 Antimalarial medicines 233.3.3 Antituberculosis medicines 243.3.4 Other medicines 253.4 Revision of texts of The International Pharmacopoeia 263.4.1 Antimalarials: artemisinin derivatives 263.4.2 Antibiotics 273.4.3 Other medicines 283.4.4 Heparin 283.5 Review of published general monographs for dosage forms 293.6 General policy topics and general revision issues 303.7 Radiopharmaceuticals 33iii
Page 1 and 2: WHO Technical Report Series957WHO E
Page 3: This report contains the collective
Page 7: Annex 1WHO good practices for pharm
Page 11 and 12: International Generic Pharmaceutica
Page 13: Declarations of interestMembers of
Page 16 and 17: implementation of guidelines and st
Page 18 and 19: various WHO activities, including t
Page 20 and 21: — stability — IGPA was working
Page 22 and 23: of the Expert Committee. The PDG pa
Page 24 and 25: The Expert Committee encouraged cou
Page 26 and 27: and Use of Essential Medicines at i
Page 28 and 29: Future work would include improving
Page 30 and 31: services/expertcommittees/pharmprep
Page 32 and 33: • Sodium pertechnetate ( 99m Tc)
Page 34 and 35: — requests for priority medicines
Page 36 and 37: • Fluconazole capsules• Flucona
Page 38 and 39: Consequent to the development of a
Page 40 and 41: Bearing in mind the application of
Page 42 and 43: 3.4.3 Other medicinesMebendazoleThe
Page 46 and 47: • those for which the strength is
Page 48 and 49: and the elaboration of 30 monograph
Page 50 and 51: 4. Quality control — internationa
Page 52 and 53: The Committee noted the final repor
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The following changes were made to
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The revised guidance text was prese
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The Expert Committee endorsed the a
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implementation of internationally a
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On the topic of risk analysis, the
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comments received and who had draft
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9. Prequalificationof priority esse
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Table 2Inspections carried out sinc
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comply with specifications and none
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the list. Failure of a manufacturer
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containing quality assurance termin
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11. Miscellaneous11.1 WHO Model Lis
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— update the entry for Canada, as
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The activities discussed during thi
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• Technetium ( 99m Tc) mertiatide
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Transfer of technology• Continue
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AcknowledgementsSpecial acknowledge
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Quality Assurance, National Institu
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76Affairs, Healthcare Distribution
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Europe, Snaith, England; Dr K. Mori
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80Polish Pharmaceutical Society, Wa
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General considerationsThe WHO Exper
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National pharmaceutical quality con
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the value of the specified property
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pharmaceutical productAny material
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standard uncertaintyUncertainty of
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1.4 The laboratory should maintain
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(g) the procurement, preparation an
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on consecutively numbered pages wit
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sufficiently competent and that the
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practices for pharmaceutical microb
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9.5 There should be a written contr
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Storage10.13 Stocks of reagents sho
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11.14 In the case that the result o
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12.12 When the equipment, instrumen
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(c) a full description of the medic
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Purpose15.2 The analytical workshee
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also serves to establish acceptance
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transfer of the required number of
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its concentration may be also reque
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21.2 General rules for safe working
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11. Supplementary guidelines in goo
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Evaluation and reporting of results
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First-stage laboratory (cont.)Ultra
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Medium-sized laboratory (cont.)Ultr
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© World Health OrganizationWHO Tec
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14.5 Returns15. Complaints and reca
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This guide covers APIs that are man
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2. Quality management2.1 Principles
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4. Making sure that all production
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4. Buildings and facilities4.1 Desi
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4.4 Containment4.40 Dedicated produ
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— when appropriate, instructions
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6. Documentation and records6.1 Doc
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• a complete list of raw material
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— the signature of the person who
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provide material meeting specificat
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8.17 Materials to be reprocessed or
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8.5 Contamination control8.50 Resid
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9.44 Packaging and labelling facili
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11.17 Primary reference standards s
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11.53 Normally the first three comm
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12.22 A validation report that cros
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during process development or for b
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analytical methods, facilities, sup
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14.42 Fresh and recovered solvents
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17.11 All agents, brokers, traders,
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18. Specific guidance for APIs manu
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18.24 See ICH Guideline Q5D (3) for
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its development. Section 19 provide
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19.82 Expiry and retest dating as d
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deviationDeparture from an approved
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quality control (QC)Checking or tes
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yield, theoreticalThe quantity that
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Thirty-fourth report. Geneva, World
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Appendix 2General notes: additional
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© World Health OrganizationWHO Tec
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2.3 In general these manufacturing
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design conditionDesign condition re
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4.3 The toxicological data availabl
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6.7 Where air is delivered through
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Figure 1Typical airflow pattern for
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pressure than the supply system. (A
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11.12 All exhaust points outside th
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References1. Quality assurance of p
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WHO good manufacturing practices fo
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using an established pharmacopoeial
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4.6.1 Clean rooms and clean-air dev
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connected by manifold to a single p
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4.10 Appropriate alert and action l
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the heating, ventilation and air-co
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5. St erilization5.1 Whenever possi
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The reading of the independent temp
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throughout the load. The informatio
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8.3 The air classification required
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with a high neck, should be worn. T
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where this difference is important,
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References1. Good manufacturing pra
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1. IntroductionDistribution is an i
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The document does not specifically
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forwarding agentA person or entity
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that the product is or may be count
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5.2 The distributor or the organiza
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7.4 National regulations relating t
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procedures in place to ensure docum
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9.12 Pharmaceutical products should
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10.11 Vehicles, containers and equi
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— date of dispatch;— complete b
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13.7 Written procedures should be i
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14.11 Mechanisms should exist to al
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17.4 Recalled pharmaceutical produc
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20.2 The number of ports of entry i
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References1. WHO guide to good stor
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• if any fraud or omissions by th
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Appendix 1Summary of key product in
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Appendix 2Variations to the product
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BackgroundA contract research organ
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3.1.7 monitor3.1.8 the study direct
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11.5 Preparation and labelling of r
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The Expert Committee on on Specific
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