- 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 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
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• Technetium ( 99m Tc) mertiatide
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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
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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
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The Expert Committee on on Specific