IQの目的

IQ（Installation Qualification）は初期の適格性評価で、構造設備等が必要とされ期待されたサービス内容を持つことの確認をおこなうことである。日本語では、据付時適格性評価と呼ばれる。

PIC/S GMP Annex 15のIQ定義は下記の通りである。

据付時適格性評価（IQ）
施設、システム、装置の据付時や変更時に、承認された設計や製造業者の提案に適合することを検証し、文書化すること。

IQは、プロセスで使用する機器つまり構造設備が正しく据え付けられたか否かを確認する活動である。
事前にIQ計画書を作成しておき、チェックリスト等に従って下記を確認する。

  • 機器の設計概要（IQの配慮事項の列挙）
  • 据付条件
  • 校正、予防保全、洗浄スケジュール
  • 安全性概要
  • サプライヤの文書、印刷物、図面およびマニュアル
  • ソフトウェアの文書（CSVを含む）
  • スペアパーツのリスト
  • 環境条件

このようにIQでは、構造設備そのものが正しく据え付けられたかを確認すると同時に、サプライヤが作成した文書類をチェックしなければならない。
つまり、構造設備を運用していく中で実施しなければならない保守作業・校正等が文書により適切に記載されており問題がないことを確認しなければならない。
また、万が一構造設備を再設置しなければならないような際に、再度適切に据え付けられるかどうかを文書で確認しておかなければならない。
なお、上記の作業のうち、いつかはサプライヤの社内で行われることがある。
構造設備のユーザである製薬企業は、当該構造設備が使用に適したものかどうかという評価、チャレンジ、テスト等に責任を負う。

PIC/S GMP Annex 15では、OQは通常IQの後に実施されるが、装置の複雑さによっては、同時にIOQとして実施しても構わないとしている。
また一般にIOQはサプライヤに実施を委託することが可能である。 ただし、最終責任は製薬企業が持たなければならない。

お役立ち動画

関連商品

[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS（手順書）ひな形　医薬品関連” ]

Related post

Comment

  1. allergy pills for rash best generic allegra best allergy pills for adults

  2. strongest sleeping pills online provigil 200mg drug

  3. order generic deltasone 20mg order prednisone 40mg generic

  4. pain relief without stomach upset purchase lincomycin generic

  5. prescription medication for severe acne buy generic retino online medication to clear acne

  6. doctor prescribed allergy medication seroflo ca skin allergy tablets list

  7. anti nausea medication from pharmacy order famotidine sale

  8. brand isotretinoin 40mg buy accutane generic buy accutane 20mg pills

  9. best sleep aids for seniors purchase phenergan without prescription

  10. cheap amoxicillin for sale amoxicillin order online buy amoxil online

  11. azithromycin over the counter azithromycin without prescription buy azithromycin 500mg for sale

  12. neurontin 600mg pill buy cheap neurontin

  13. order azipro 250mg sale buy azipro online oral azithromycin

  14. purchase furosemide pills furosemide 100mg cost

  15. cost prednisolone order prednisolone sale prednisolone 10mg drug

  16. buy deltasone sale purchase prednisone pills

  17. order amoxicillin order amoxil 500mg generic order amoxicillin 250mg sale

  18. buy doxycycline 100mg online cheap order doxycycline 100mg sale

  19. albuterol price buy ventolin pills order ventolin inhalator online cheap

  20. buy generic augmentin over the counter augmentin cost

  21. buy generic synthroid 150mcg synthroid 150mcg cost generic synthroid 150mcg

  22. levitra tablet vardenafil 10mg price

  23. clomiphene 50mg sale brand serophene clomiphene over the counter

  24. order rybelsus 14 mg pill semaglutide price buy semaglutide generic

  25. order semaglutide 14 mg pills order rybelsus 14 mg generic rybelsus 14mg for sale

  26. order deltasone 10mg without prescription deltasone 5mg pills prednisone 40mg over the counter

  27. isotretinoin 10mg pills buy generic accutane for sale order isotretinoin generic

  28. buy ventolin 2mg order ventolin sale albuterol buy online

  29. cheap amoxil pill buy amoxicillin cheap amoxil without prescription

  30. buy cheap generic augmentin order augmentin 1000mg online buy generic clavulanate

  31. azithromycin 250mg oral order azithromycin 500mg without prescription azithromycin 250mg generic

  32. buy generic synthroid for sale levothyroxine usa buy synthroid sale

  33. buy prednisolone 40mg for sale brand prednisolone 20mg oral omnacortil

  34. serophene without prescription serophene generic clomiphene price

  35. oral gabapentin buy gabapentin online cheap buy gabapentin 600mg online

  36. female viagra cvs real viagra pills viagra 50mg generic

  37. furosemide 40mg usa furosemide without prescription buy furosemide diuretic

  38. semaglutide oral buy semaglutide tablets cheap semaglutide 14 mg

  39. poker online sites play blackjack online for real money online blackjack best

  40. order vardenafil pill levitra 10mg pill vardenafil pills

  41. pregabalin uk how to get lyrica without a prescription lyrica 75mg pills

  42. hydroxychloroquine 200mg us plaquenil 400mg oral buy hydroxychloroquine 400mg pill

  43. triamcinolone price order triamcinolone 10mg pill triamcinolone pills

  44. cheap cialis 20mg buy tadalafil 20mg sale order generic cialis 20mg

  45. buy clarinex generic buy clarinex pill buy clarinex 5mg generic

  46. cheap cenforce 100mg generic cenforce 50mg buy cenforce 100mg sale

  47. claritin 10mg canada purchase claritin pills generic loratadine

  48. buy chloroquine 250mg generic chloroquine 250mg cheap aralen 250mg usa

  49. dapoxetine 60mg pills misoprostol 200mcg cheap order misoprostol 200mcg without prescription

  50. buy metformin generic buy glucophage 1000mg online cheap glycomet 1000mg ca

  51. where can i buy xenical cost diltiazem diltiazem for sale online

  52. norvasc drug order amlodipine 5mg pills order amlodipine 5mg online cheap

  53. buy generic acyclovir over the counter buy zyloprim 100mg pills zyloprim 300mg tablet

  54. buy zestril 5mg sale zestril 2.5mg tablet buy lisinopril medication

  55. buy crestor 10mg sale zetia 10mg over the counter buy generic zetia over the counter

  56. order prilosec 10mg sale purchase omeprazole generic buy omeprazole pill

  57. motilium price oral tetracycline 500mg buy cheap sumycin

  58. purchase metoprolol online generic metoprolol 100mg buy generic metoprolol

  59. flexeril drug buy ozobax sale purchase baclofen generic

  60. atenolol generic atenolol us atenolol 100mg cost

  61. cost toradol order colcrys pills colcrys 0.5mg sale

  62. depo-medrol us methylprednisolone 16mg online medrol 8 mg without prescription

  63. pay for assignment pay for assignment essays done for you

  64. inderal 10mg ca inderal 10mg for sale clopidogrel price

  65. order methotrexate generic methotrexate tablet buy warfarin tablets

  66. oral meloxicam 7.5mg mobic drug order celebrex 100mg without prescription

  67. buy metoclopramide 20mg for sale purchase reglan online order cozaar 25mg generic

  68. buy generic flomax for sale celebrex oral purchase celecoxib sale

  69. buy esomeprazole pills for sale buy nexium 40mg without prescription topamax 100mg for sale

  70. how to buy zofran ondansetron sale buy aldactone online cheap

  71. purchase imitrex sale buy levaquin 500mg pills buy levofloxacin generic

  72. order zocor without prescription simvastatin 10mg without prescription buy valtrex sale

  73. purchase dutasteride pills buy dutasteride without a prescription cheap ranitidine 150mg

  74. finpecia medication brand finasteride 1mg buy fluconazole 100mg generic

  75. acillin ca vibra-tabs online order amoxil without prescription

  76. cipro 1000mg us – bactrim cheap where can i buy clavulanate

  77. baycip online buy – cephalexin ca augmentin 1000mg oral

  78. buy ciplox no prescription – tinidazole 500mg cheap erythromycin online order

  79. flagyl oral – buy terramycin without prescription buy zithromax online cheap

  80. buy ivermectin tablets – sumycin cheap order sumycin 500mg online

  81. valacyclovir 500mg oral – order diltiazem 180mg order zovirax 800mg pill

  82. purchase ampicillin pill purchase ampicillin for sale order amoxil online cheap

  83. purchase lasix – generic tacrolimus 1mg captopril ca

  84. glucophage 1000mg price – generic cefadroxil 500mg order lincomycin pill

  85. buy zidovudine for sale – epivir online order zyloprim pills

  86. buy clozapine medication – order ramipril 5mg online cheap famotidine brand

  87. buy quetiapine pills – buy sertraline 50mg generic cheap eskalith pills

  88. anafranil 50mg price – buy remeron pills for sale order sinequan generic

  89. buy atarax generic – buy sarafem online brand endep 25mg

  90. buy augmentin medication – zyvox 600mg tablet ciprofloxacin 1000mg for sale

  91. amoxicillin over the counter – buy cefadroxil 250mg ciprofloxacin 1000mg over the counter

  92. purchase zithromax without prescription – buy ciplox medication buy ciplox 500mg generic

  93. order cleocin 150mg – buy generic cefpodoxime 200mg cheap chloromycetin sale

  94. oral stromectol cost – order levofloxacin cefaclor 250mg cost

  95. purchase albuterol inhalator – advair diskus inhalator uk theophylline cheap

  96. medrol 16mg tablet – fml-forte cost azelastine brand

  97. desloratadine over the counter – flixotide brand order ventolin 2mg pills

  98. order generic glyburide 5mg – buy glyburide 2.5mg without prescription order forxiga generic

  99. order glucophage 1000mg online cheap – order glycomet 500mg generic order acarbose 25mg sale

  100. buy prandin medication – order empagliflozin 10mg generic order jardiance 25mg sale

  101. semaglutide 14 mg over the counter – cost rybelsus order DDAVP online

  102. order lamisil generic – terbinafine over the counter buy cheap generic grifulvin v

  103. buy ketoconazole medication – mentax price buy sporanox 100mg online

  104. purchase famciclovir generic – valaciclovir order buy valcivir pills

  105. order lanoxin 250mg pills – lanoxin ca lasix 40mg canada

  106. buy metoprolol – cozaar 25mg oral order generic nifedipine 30mg

  107. microzide 25 mg generic – order amlodipine 5mg for sale buy bisoprolol pills

  108. purchase nitroglycerin sale – buy generic combipres cheap diovan

  109. rosuvastatin pills suspicious – zetia anyhow caduet buy quill

  110. simvastatin blame – lipitor practical atorvastatin remember

  111. buy viagra professional shake – eriacta grass levitra oral jelly online parlour

  112. dapoxetine three – fildena clean cialis with dapoxetine cigar

  113. cenforce appear – brand viagra online intelligence brand viagra online badge

  114. brand cialis inner – apcalis skill penisole lean

  115. brand cialis white – penisole express penisole extra

  116. cialis soft tabs guy – tadarise joe viagra oral jelly online simple

  117. cialis soft tabs explanation – cialis soft tabs hole viagra oral jelly memory

  118. cenforce honest – cialis tadalafil brand viagra online paint

  119. priligy steer – fildena strain cialis with dapoxetine swarm

  120. acne medication sudden – acne medication variety acne treatment scarce

  121. inhalers for asthma snatch – asthma medication better inhalers for asthma gesture

  122. uti treatment morrow – uti treatment hoarse treatment for uti amaze

  123. prostatitis medications firm – prostatitis pills mr prostatitis medications member

  124. loratadine medication fog – loratadine substance loratadine medication century

  125. valtrex online property – valacyclovir online wet valtrex honest

  126. dapoxetine small – dapoxetine sacrifice dapoxetine farmer

  127. claritin pills mask – loratadine medication trade loratadine platform

  128. ascorbic acid blossom – ascorbic acid slop ascorbic acid disturb

  129. promethazine counter – promethazine scene promethazine fruit

  130. biaxin utmost – clarithromycin pills rabbit cytotec period

  131. florinef subject – pantoprazole hill prevacid pills understand

  132. aciphex 20mg canada – rabeprazole 20mg brand domperidone price

  133. bisacodyl usa – dulcolax 5mg without prescription how to buy liv52

  134. buy eukroma paypal – cerazette without prescription order duphaston 10mg

  135. buy bactrim 480mg pills – purchase keppra buy tobrex generic

  136. fulvicin 250mg for sale – buy generic gemfibrozil 300mg buy gemfibrozil 300 mg generic

  137. forxiga generic – doxepin us buy acarbose

  138. dimenhydrinate order online – brand dimenhydrinate 50mg buy risedronate 35mg generic

  139. order enalapril 10mg pills – buy xalatan sale buy generic zovirax

  140. order monograph pills – order monograph 600mg online cilostazol order

  141. feldene 20mg ca – purchase piroxicam sale exelon pills

  142. nootropil 800 mg without prescription – sustiva 10mg brand sinemet online

  143. buy hydroxyurea online cheap – order hydroxyurea without prescription robaxin usa

TOP