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

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— stability — IGPA was working with certain national associationsregarding implementation of the latest WHO stability guidelines.Inter national Pharmaceutical FederationThe International Pharmaceutical Federation (FIP) reported that overthe past year FIP and WHO had established work plans to support theirinvolvement in key strategic collaborative areas of work. FIP’s main prioritywas medicines and strengthening the pharmaceutical workforce. Other areasof importance included the roles and added value of pharmacists in patientsafety, primary health care, noncommunicable diseases and maternal,newborn and child health. FIP continued to collaborate on these projectsrelated to medicines in WHO.In particular the issue of good distribution practices (GDP) is an importantelement in securing the legitimate supply and distribution chain, and also inpreventing the infiltration of counterfeit medical products (see section 8.2).FIP played an active role in the final revision and drafting of the WHO GDPguidelines in September 2009. FIP had produced a WHO/FIP Handbook onDeveloping Pharmacy Practice and is currently working towards a revisionof the FIP/WHO guidelines on good pharmacy practice (GPP). FIP alsoassisted IMPACT in improving the information available to the publicregarding counterfeit medicines and the work of IMPACT.United Nations Children’s FundThe United Nations Children’s Fund (UNICEF) promotes and protectschildren’s rights, especially those of the most vulnerable in the poorestcountries. UNICEF core commitments are health and nutrition, education,water and sanitation, child protection and HIV/AIDS.One of the main activities of UNICEF is the supply of quality medicinesto countries and communities in need; the supply headquarters is locatedin Copenhagen. The Supply Division oversees UNICEF’s global supplyprocurement and logistics operations on behalf of UNICEF and itsprocurement services partners. It ensures that supplies of high quality andgood value reach children and their families quickly.Prequalification of suppliers of pharmaceuticals in UNICEF involves the reviewof submitted documentation and/or GMP inspections to ensure compliance withWHO GMP guidelines using a technical questionnaire developed by WHO. Thetechnical questionnaire covers manufacturing sites, dosage forms and productsof interest, export experience and licence to manufacture pharmaceuticals.Local authorities are invited to participate in GMP inspections. There are alsojoint inspections with WHO and other partners.Decisions are based on the regulatory environment in the country of originand prior experience of UNICEF, GMP inspection by UNICEF or by a6
epresentative selected by UNICEF. Contract manufacture is only acceptedif the subcontractor is also approved by UNICEF. Inspections are carried outprimarily by UNICEF staff who check compliance with WHO GMP guidelines.During 2003–2009, 145 GMP inspections carried out in 47 companies failed(32%). In case of failure a detailed GMP inspection report is forwarded to thecompany with a request to respond within one month.In case of prequalification of vaccines, HIV, malaria and tuberculosisproducts:— products have to be prequalified by WHO and listed on the WHO website;— the supplier has to confirm to UNICEF that the products are identical tothose assessed by WHO/UNICEF; and— UNICEF’s purchase is traced in WHO/UNICEF GMP inspections.2.1.2 Pharmacopoeial Discussion GroupThe Pharmacopoeial Discussion Group (PDG), which consists of theEuropean Pharmacopoeia, Japanese Pharmacopoeia and United StatesPharmacopeia, met in association with the Expert Working Groups of theInternational Conference on Harmonisation (ICH) from 8 to 12 June 2009in Yokohama, Japan. The Secretary of this Expert Committee participatedas an observer for WHO.The experts recommended reviews of the following general methods againstexisting related International Pharmacopoeia (Ph.Int.) texts and addingthose not yet included in the Ph.Int. for future adoption:• Test for extractable volume of parenteral preparations (General Chapter);• Test for particulate contamination: sub-visible particles (General Chapter);• Disintegration test;• Dissolution test (General Chapter) (pending availability of final text);• Sterility test (General Chapter);• Microbiological examination of non-sterile products; and• Acceptance criteria for pharmaceutical preparations and substances forpharmaceutical use (General Chapter).The Committee recommended that the following should be considered foradoption:• Microbiological examination of non-sterile products:— Microbial enumeration tests (General Chapter);— Tests for specified microorganisms (General Chapter); and• Tablet friability (General Chapter).The Secretariat informed the experts that preliminary discussions had alreadybeen held with the PDG members, based on previous recommendations7
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 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
Page 84 and 85:
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
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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
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
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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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