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

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Dr H.V. Hogerzeil, Director, Essential Medicines and Pharmaceutical Policies,WHO, Geneva, SwitzerlandDr L. Rägo, Coordinator, Quality Assurance and Safety: Medicines, WHO, Geneva,SwitzerlandDr S. Kopp, Manager, Medicines Quality Assurance Programme, Quality Assuranceand Safety: Medicines, WHO, Geneva, Switzerland (Secretary)Ms C. Mendy, Medicines Quality Assurance Programme, Quality Assurance andSafety: Medicines, WHO, Geneva, SwitzerlandDr R. Balocco, Manager, International Nonproprietary Names Programme, QualityAssurance and Safety: Medicines, WHO, Geneva, SwitzerlandDr A. Gould, Manager, Prequalifi cation Programme, Quality Assurance and Safety:Medicines, WHO, Geneva, SwitzerlandDr R. Kuwana, Prequalifi cation Programme, Quality Assurance and Safety:Medicines, WHO, Geneva, SwitzerlandDr M. Mehmandoust, Prequalifi cation Programme, Quality Assurance and Safety:Medicines, WHO, Geneva, SwitzerlandMr D. Mubangizi, Prequalifi cation Programme, Quality Assurance and Safety:Medicines, WHO, Geneva, SwitzerlandMs J. Sabartova, Prequalifi cation Programme, Quality Assurance and Safety:Medicines, WHO, Geneva, SwitzerlandDr I. Streipa, Prequalifi cation Programme, Quality Assurance and Safety: Medicines,WHO, Geneva, Switzerland, WHO, Geneva, SwitzerlandMr W.Z. Worku, Prequalifi cation Programme, Quality Assurance and Safety:Medicines, WHO, Geneva, SwitzerlandDr Hua Yin, Prequalifi cation Programme, Quality Assurance and Safety: Medicines,WHO, Geneva, SwitzerlandDr A. van Zyl, Head, Inspections, Prequalifi cation Programme, Quality Assuranceand Safety: Medicines, WHO, Geneva, SwitzerlandDr S. Azatyan, Manager, Medicines Regulatory Support Programme, WHO,Geneva, SwitzerlandMr J. Hetzke, Health Systems and Services, WHO, Geneva, SwitzerlandMs Y. Maruyama, Traditional Medicine, WHO, Geneva, SwitzerlandDr C. Ondari, Coordinator, Medicines Access and Rational Use, WHO, Geneva,SwitzerlandDr F. Renaud Théry, HIV Systems Strengthening, WHO, Geneva, SwitzerlandDr D.J. Wood, Coordinator, Quality, Safety and Standards Programme, WHO,Geneva, Switzerlandx
Declarations of interestMembers of the WHO Expert Committee on Specifications forPharmaceutical Preparations reported the following:Professor Saleh A. Bawazir, Professor Theo G. Dekker, Ms Nilka M. GuerreroRivas, Professor Jos Hoogmartens, Professor Jin Shaohong, Dr JohnH.McB. Miller, Dr Justina A. Molzon and Mr Eshetu WondemagegnehuBiwota reported no conflict of interest.Temporary and special advisers reported the following:Professor Ivan Addae-Mensah, Dr Simon Mills, Ms Marie-LouiseRabouhans, Dr Birgit Schmauser, Dr Saranjit Singh and Mr Deryck Smith,reported no conflict of interest.Mr Robert Tribe reported that he was a consultant with two commercialentities and was the owner of another one.Mr Martin FitzGerald, attending as an observer, reported that he wasLegal Adviser with the European Association of Pharmaceutical Full-Line Wholesalers; Dr Piotr Kozarewicz (representative of the EuropeanMedicines Agency) reported that he was employed by two differentpharmaceutical companies in Poland from September 2003 until June 2006.Other participants reported no conflict of interest.xi
Page 1 and 2: WHO Technical Report Series957WHO E
Page 3 and 4: This report contains the collective
Page 5 and 6: Contents1. Introduction 12. General
Page 7: Annex 1WHO good practices for pharm
Page 11: International Generic Pharmaceutica
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
Page 54 and 55: The following changes were made to
Page 56 and 57: The revised guidance text was prese
Page 58 and 59: The Expert Committee endorsed the a
Page 60 and 61: implementation of internationally a
Page 62 and 63:
On the topic of risk analysis, the
Page 64 and 65:
comments received and who had draft
Page 66 and 67:
9. Prequalificationof priority esse
Page 68 and 69:
Table 2Inspections carried out sinc
Page 70 and 71:
comply with specifications and none
Page 72 and 73:
the list. Failure of a manufacturer
Page 74 and 75:
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
Page 96 and 97:
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
Page 186 and 187:
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
Page 204 and 205:
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
Page 290 and 291:
11.5 Preparation and labelling of r
Page 292:
The Expert Committee on on Specific
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