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

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Consequent to the development of a new monograph for Quinine bisulfatetablets, a revision of the published text for the quinine sulfate dosageform adopted in October 2008 was required to add an additional identitytest allowing the differentiation between the two sulfate forms of quininepossibly used in tablet formulations.A revision of the published text of the following antimalarial dosage formwas thus presented to the Expert Committee for discussion. The revisedmonograph was adopted, subject to inclusion of the comments receivedduring the public inquiry and those made during the discussion:• Quinine sulfate tablets3.3.3 Antituberculosis medicinesRevisions of the published texts of the following antibiotics’ activesubstances, for which an International Chemical Reference Substance (ICRS)was no longer available and thus a new method for assay was needed, werepresented for discussion (see paragraph 3.4.2 for antibiotics), together witha new monograph for the corresponding dosage form. The monographs wereadopted, subject to inclusion of the agreed changes, based on the commentsreceived during the public inquiry and those made during discussion:APIs• Amikacin• Amikacin sulfateDosage form• Amikacin injectionNew monographs for the following antibiotics active substances anddosage form for which an ICRS was still available, and thus included anassay by a microbiological method, were also presented for discussion.The monographs were adopted, subject to inclusion of the agreed changes,based on the comments received during the public inquiry and those madeduring discussion:APIs• Kanamycin monosulfate• Kanamycin acid sulfateDosage form• Kanamycin injectionFor the Kanamycin injection monograph, the issue of the determinationof the conversion factor from international units (IU) to micrograms wasraised. The Expert Committee recommended that this monograph becirculated again for comment on this specific aspect.24
3.3.4 Other medicinesOxytocinA draft proposal for oxytocin was initially sent out for comment in 2007and presented for discussion at the forty-second meeting of the ExpertCommittee in October 2008. A revised draft monograph, reflecting thecomments received and the Expert Committee’s recommendations, wasrecirculated for comment in January 2009. The new comments receivedwere discussed during the consultation on specifications for medicines andquality control laboratory issues in June 2009, paying special attention tothe following aspect of the monograph:• limits for assayA revised text was presented to the Expert Committee for discussion. Themonograph was adopted, subject to inclusion of the agreed changes, basedon the comments received during the public inquiry and those made duringthe discussion.Oxytocin injectionA draft proposal for Oxytocin injection was initially sent out for comment in2007 and presented for discussion at the forty-second meeting of the ExpertCommittee in 2008. A revised draft monograph, reflecting the commentsreceived and the Expert Committee’s recommendations, was recirculatedfor comment in January 2009. The new comments received were discussedduring the consultation on specifications for medicines and quality controllaboratory issues in June 2009, paying special attention to the aspects of themonograph presented below.Storage/stability/pHThe storage of Oxytocin injection was a matter of concern since thisinjection was widely used in developing countries with hot climatesand where refrigeration was not available. It was used by a range ofhealth professionals and health providers (e.g. midwives) as well as inemergency situations. <strong>WHO</strong> was actively promoting its use by “skilledattendants” for the prevention and treatment of postpartum haemorrhageas part of “Making Pregnancy Safer” (http://www.who.int/making_pregnancy_safer/en/) (Millennium Development Goals for maternal andchild health).The draft monograph circulated in 2007 recommended a storagetemperature of between 2°C and 8°C (i.e. in a refrigerator) in line with therecommendations of the major manufacturers. This aspect of the monographwas reviewed by the Secretariat in light of current debate on stability ofOxytocin formulations.25
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 34 and 35: — requests for priority medicines
Page 36 and 37: • Fluconazole capsules• Flucona
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
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
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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
Page 292:
The Expert Committee on on Specific
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