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

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services/expertcommittees/pharmprep/170909Clean_GDP-counterfeits-QAS08252Rev1.pdfThe planned IMPACT meetings (subject to resources) were as follows:— regional meeting in South Africa (9–10 November 2009);— annual meeting of IMPACT Planning Group including all IMPACTChairs and Co-Chairs (January 2010);— Open Forum for WHO Member States and interested parties, involvingIMPACT partners (January 2010);— Working Group meetings (January 2010); and— annual IMPACT meeting (after the World Health Assembly in May2010).The Committee was pleased to note the continued cooperation with otherWHO departments and programmes.3. Quality control — specifications and tests3.1 The International PharmacopoeiaFollowing the publication of the First Supplement to the Fourth Edition,the Expert Committee was informed that the final texts for the monographsadopted at the forty-second and forty-third meetings in October 2007 and2008 had been made available to users of the WHO Medicines web siteand that they were ready to be included in the forthcoming issue of TheInternational Pharmacopoeia (Ph.Int.). While the format of this futurepublication was still to be defined (electronic, CD-ROM or book), atentative table of contents of about 45 texts for inclusion in this publicationwas discussed and adopted.Provisional list of contents for the forthcoming publicationof The International PharmacopoeiaMonographs adopted at the forty-second meetingof the Expert Committee in October 2007Pharmaceutical substances• Lumefantrine• Zinc sulfateDosage forms• Artemether and lumefantrine tablets• Magnesium sulfate injection• Rifampicin and isoniazid dispersible tablets• Rifampicin, isoniazid and ethambutol tablets16
• Rifampicin, isoniazid and pyrazinamide dispersible tablets• Zinc sulfate oral solution (paediatric)• Zinc sulfate tablets (paediatric)Monographs adopted at the forty-third meeting of the ExpertCommittee in October 2008Pharmaceutical substances• Emtricitabine• Mebendazole (revision of published monograph)• Nevirapine (revision of published monograph)• Oseltamivir phosphateDosage forms• Artemether and lumefantrine oral suspension• Mebendazole chewable tablets (revision of published monograph formebendazole tablets)• Chloroquine sulfate oral solution• Cycloserine capsules• Efavirenz capsules• Efavirenz oral solution• Ethambutol hydrochloride tablets (revision of published monograph)• Nevirapine oral suspension• Nevirapine tablets• Quinine sulfate tablets• Zidovudine, lamivudine and nevirapine tabletsRadiopharmaceuticalsGeneral monograph and related texts• General monograph• Methods of analysis• Supplementary information• Individual monographs• Fludeoxyglucose ( 18 F) injection• Gallium citrate ( 67 Ga) injection• Iobenguane ( 123 I) injection• Iobenguane ( 131 I) injection• Samarium ethylene diamine tetramethylene phosphonate complex ( 153 Sm)injection• Sodium iodide ( 131 I) capsules• Sodium iodide ( 131 I) injection• Sodium iodide ( 131 I) solution• Sodium iothalamate ( 125 I) injection17
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 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 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
Page 76 and 77: 11. Miscellaneous11.1 WHO Model Lis
Page 78 and 79: — update the entry for Canada, as
Page 80 and 81:
The activities discussed during thi
Page 82 and 83:
• Technetium ( 99m Tc) mertiatide
Page 84 and 85:
Transfer of technology• Continue
Page 86 and 87:
AcknowledgementsSpecial acknowledge
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Quality Assurance, National Institu
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76Affairs, Healthcare Distribution
Page 92 and 93:
Europe, Snaith, England; Dr K. Mori
Page 94 and 95:
80Polish Pharmaceutical Society, Wa
Page 96 and 97:
General considerationsThe WHO Exper
Page 98 and 99:
National pharmaceutical quality con
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the value of the specified property
Page 102 and 103:
pharmaceutical productAny material
Page 104 and 105:
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
Page 114 and 115:
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
Page 128 and 129:
also serves to establish acceptance
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transfer of the required number of
Page 132 and 133:
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
Page 148 and 149:
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
Page 180 and 181:
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
Page 190 and 191:
18.24 See ICH Guideline Q5D (3) for
Page 192 and 193:
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
Page 206 and 207:
© World Health OrganizationWHO Tec
Page 208 and 209:
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
Page 216 and 217:
Figure 1Typical airflow pattern for
Page 218 and 219:
pressure than the supply system. (A
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11.12 All exhaust points outside th
Page 222 and 223:
References1. Quality assurance of p
Page 224 and 225:
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
Page 242 and 243:
8.3 The air classification required
Page 244 and 245:
with a high neck, should be worn. T
Page 246 and 247:
where this difference is important,
Page 248 and 249:
References1. Good manufacturing pra
Page 250 and 251:
1. IntroductionDistribution is an i
Page 252 and 253:
The document does not specifically
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forwarding agentA person or entity
Page 256 and 257:
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
Page 262 and 263:
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
Page 272 and 273:
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
Page 280 and 281:
• if any fraud or omissions by th
Page 282 and 283:
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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