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

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— requests for priority medicines recommended in <strong>WHO</strong> specific diseaseprogrammes.After discussion, the Expert Committee adopted the following new workprogramme.Additions to the 2009 work plan are indicated below in bold.Updated new work programmeMedicines used in the treatment of HIV/AIDS and relatedconditionsAPI• AtazanavirDosage forms• Atazanavir capsules• Didanosine capsules• Efavirenz tablets• Emtricitabine capsules• Emtricitabine oral solution• Ritonavir capsules• Ritonavir oral solution• Stavudine powder for oral solution• Zidovudine tabletsFixed-dose combinations• Lopinavir and ritonavir caspules• Lopinavir and ritonavir oral solutionDosage forms, including those for paediatric use, as available for:• Efavirenz + emtricitabine + tenofovir• Lamivudine + stavudine• Lamivudine + stavudine + efavirenz• Lamivudine + stavudine + nevirapine• Lamivudine + zidovudine + efavirenz• Tenofovir + emtricitabineMedicines used in malaria treatmentAPI• Piperaquine phosphateDosage forms• Mefloquine tablets (used in co-blisters)20
Fixed-dose combinations• Artemether and lumefantrine capsules• Artemether and lumefantrine dispersible tablets• Artesunate and amodiaquine tablets• Artesunate, sulfadoxine and pyrimethamine tablets• Sulfadoxine and pyrimethamine tablets (used in co-blisters)Dosage form, including that for paediatric use, as available for:• Dihydroartemisinin + piperaquine phosphateRevision• Artemisinin derivatives (APIs and dosage forms) (see http://www.who.int/medicines/publications/pharmacopoeia/mon_mal/en/index.html)Medicines used in tuberculosis treatmentAPIs• p-Aminosalicylic acid• Capreomycin• Levofloxacin• Ofloxacin• TerizidoneDosage forms• p-Aminosalicylic acid granules• Capreomycin powder for injection• Ethionamide tablets• Levofloxacin tablets• Ofloxacin tablets• Protionamide tablets• Terizidone tabletsAnti-infectives (antibacterials, antiprotozoal, antifungal,antiviral and antimycobacterial agents, anthelmintics)APIs• Ceftriaxone sodium• Fluconazole• IvermectinDosage forms• Albendazole chewable tablets• Amoxicillin oral suspension• Ceftriaxone injection• Doxycycline dispersible tablets21
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 30 and 31: services/expertcommittees/pharmprep
Page 32 and 33: • Sodium pertechnetate ( 99m Tc)
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
Page 88 and 89:
Quality Assurance, National Institu
Page 90 and 91:
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
Page 100 and 101:
the value of the specified property
Page 102 and 103:
pharmaceutical productAny material
Page 104 and 105:
standard uncertaintyUncertainty of
Page 106 and 107:
1.4 The laboratory should maintain
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(g) the procurement, preparation an
Page 110 and 111:
on consecutively numbered pages wit
Page 112 and 113:
sufficiently competent and that the
Page 114 and 115:
practices for pharmaceutical microb
Page 116 and 117:
9.5 There should be a written contr
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Storage10.13 Stocks of reagents sho
Page 120 and 121:
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
Page 130 and 131:
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
Page 140 and 141:
First-stage laboratory (cont.)Ultra
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Medium-sized laboratory (cont.)Ultr
Page 144 and 145:
© World Health OrganizationWHO Tec
Page 146 and 147:
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
Page 152 and 153:
4. Making sure that all production
Page 154 and 155:
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
Page 166 and 167:
provide material meeting specificat
Page 168 and 169:
8.17 Materials to be reprocessed or
Page 170 and 171:
8.5 Contamination control8.50 Resid
Page 172 and 173:
9.44 Packaging and labelling facili
Page 174 and 175:
11.17 Primary reference standards s
Page 176 and 177:
11.53 Normally the first three comm
Page 178 and 179:
12.22 A validation report that cros
Page 180 and 181:
during process development or for b
Page 182 and 183:
analytical methods, facilities, sup
Page 184 and 185:
14.42 Fresh and recovered solvents
Page 186 and 187:
17.11 All agents, brokers, traders,
Page 188 and 189:
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
Page 194 and 195:
19.82 Expiry and retest dating as d
Page 196 and 197:
deviationDeparture from an approved
Page 198 and 199:
quality control (QC)Checking or tes
Page 200 and 201:
yield, theoreticalThe quantity that
Page 202 and 203:
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
Page 210 and 211:
design conditionDesign condition re
Page 212 and 213:
4.3 The toxicological data availabl
Page 214 and 215:
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
Page 220 and 221:
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
Page 226 and 227:
using an established pharmacopoeial
Page 228 and 229:
4.6.1 Clean rooms and clean-air dev
Page 230 and 231:
connected by manifold to a single p
Page 232 and 233:
4.10 Appropriate alert and action l
Page 234 and 235:
the heating, ventilation and air-co
Page 236 and 237:
5. St erilization5.1 Whenever possi
Page 238 and 239:
The reading of the independent temp
Page 240 and 241:
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
Page 254 and 255:
forwarding agentA person or entity
Page 256 and 257:
that the product is or may be count
Page 258 and 259:
5.2 The distributor or the organiza
Page 260 and 261:
7.4 National regulations relating t
Page 262 and 263:
procedures in place to ensure docum
Page 264 and 265:
9.12 Pharmaceutical products should
Page 266 and 267:
10.11 Vehicles, containers and equi
Page 268 and 269:
— date of dispatch;— complete b
Page 270 and 271:
13.7 Written procedures should be i
Page 272 and 273:
14.11 Mechanisms should exist to al
Page 274 and 275:
17.4 Recalled pharmaceutical produc
Page 276 and 277:
20.2 The number of ports of entry i
Page 278 and 279:
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
Page 284 and 285:
Appendix 2Variations to the product
Page 286 and 287:
BackgroundA contract research organ
Page 288 and 289:
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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