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

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Future work would include improving feedback and identification of needsfor guidance, establishing a pool of regulatory experts and conducting theassessment of medicines regulatory systems in a more systematic wayand for training purposes. The programme intends to establish a networkof centres of excellence in the regulatory affairs area to serve as trainingcentres, design new intervention mechanisms for supporting activities andnew concepts for conducting day-to-day work.2.2.6 HIV-related activitiesThe representative of the HIV Department, Strategic Information and ResearchUnit, gave a short update on how the work of this Expert Committee was usefulto the HIV Department’s activities. The Department published an annualreport entitled “Towards universal access” on progress made in the healthsector to address the HIV epidemic. In the section on access to treatment, itreported on the progress made on prequalification of antiretrovirals by QSM.A QSM quality assessment survey was also included in the 2008 report.2.3 Counterfeit medicinesThe Committee was provided with an update by the Programme Manager ofthe newly created EMP/QSM Anti-Counterfeiting Programme (ACM), whowas also Executive Secretary ad interim of the IMPACT Secretariat.Discussion took place during the Executive Board meeting in January 2009on IMPACT and counterfeit medicines in general. Concerns had been raisedregarding WHO’s role in this area. Two background papers had been preparedby the WHO Secretariat and submitted to the World Health Assembly (oneon the activities of IMPACT and the second on WHO’s activities in the areaof counterfeit (http://apps.who.int/gb/e/e_wha62.html, WHA62: A62/13Counterfeit medical products, and A62/14 Counterfeit medical products:International Medical Products Anti-Counterfeiting Taskforce). Additionalinformation on IMPACT could be found on the web site (http://www.who.int/impact). The Assembly agenda item on counterfeits was subsequentlypostponed to 2010.The Secretariat and Chair for IMPACT continued to be based in WHO.The Director-General of WHO reconfirmed that counterfeit medicines werean important issue for the Organization and that WHO would continue tocollaborate with partners in this field. The WHO Secretariat would work onthe basis that there were no changes to this current situation at least until theWorld Health Assembly in May 2010, during which WHO’s role should beclarified by its Member States.ACM would complete the following activities in 2009:• Revise and update the WHO and IMPACT web sites.14
• Proceed with the joint WHO Expert Committee on Specificationsfor Pharmaceutical Preparations/IMPACT review of the WHO Gooddistribution practices (GDP) for pharmaceutical products, which wasproposed by IMPACT in 2007.• Start the review process of the draft document on Model Legislationdeveloped by IMPACT in 2008, including a revision of the currentdefinition of counterfeit medicines, possibly through the ExpertCommittee.• Plan and implement advocacy, training, country support and enforcementactivities with interested governments in Africa, as far as specified donorfunds were available (mostly from the European Union for African,Caribbean and Pacific countries).• Recruit one technical expert on regulatory matters and pursue thepossibility of FIP arranging the secondment of a communication expert.• Prepare a fund-raising plan for future staff and activities to combatcounterfeit medicines and approach interested donors.In addition to WHO’s work on counterfeit medicines described above, theAssistant Director-General, HSS would continue her two-year mandate aselected Chair of IMPACT and WHO would continue to fulfil the functionsof the IMPACT Secretariat. As such WHO would continue to work withIMPACT, drawing on its technical input and the involvement of a largenumber of stakeholders, whilst clearly distinguishing between documentsprepared by IMPACT and those issued by WHO.Technical documents prepared by IMPACT working groups would be postedon the IMPACT web site, without the WHO logo. These could be reviewed,adapted and ultimately approved as appropriate, through the normal WHOconsultative procedures.The IMPACT web site would be revised and updated. It would includethe proposal for the Draft principles and elements for national legislationagainst counterfeit medical products, inviting comments thereon. A CircularLetter would be prepared to draw Member States’ attention to this draftdocument and the new proposal for the definition of counterfeit medicalproducts contained therein.A direct link to the above-mentioned document was available in thenews section of the IMPACT web site (http://www.who.int/impact/news/BonnMeetingDraftPrinciples.pdf).A proposed revision of the WHO Good Distribution Practices (GDP) forpharmaceutical products was discussed by this Expert Committee with a view toits adoption. The document could be found on the WHO web site at: http://www.who.int/medicines/services/expertcommittees/pharmprep/43rdpharmprep/en/index.html, and also with a direct link: http://www.who.int/medicines/15
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 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
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
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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
Page 290 and 291:
11.5 Preparation and labelling of r
Page 292:
The Expert Committee on on Specific
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