シニアマネジメントはGMPの責任を負うか

2016年12月13日、デンマーク当局(DKMA)による査察(内部告発による)で、Europharmaという会社の重大なGMPコンプライアンス違反が露見した。
再包装された医薬品の有効期限を改ざんしていたのである。
当局は同社に対し、製品の製造および輸入の禁止を命じた。
また、当局は「CEOの交替」を要求した。
会社の不正はトップの責任だという当局の考えの表れが強く出ているケースである。

このデンマークの事例が示すように、過去にEUの当局は、品質の低下に責任を持つために、有資格者(Qualified Persons:QPs)に焦点を当ててきた、しかし、多くの企業では、QPはシニアよりもむしろ中間管理職が務めている。
2008年のICH Q10 「医薬品品質システム」(PQS)ガイドラインにより、上級管理職が最終的に効果的な医薬品品質システムを確保する責任を負うという新しい考え方が支持された。
これは後にEU-GMPガイドラインの更新に反映されている。
EU GMP Annex 16 「QPの承認およびバッチリリース」には、医薬品のライフサイクル、安全性、品質および有効性に対する最終的な責任は、マーケティング認可保有者(MAH)にあると記載されている。

(注)QPはEU圏の規制であるため、PIC/S GMP Annex 16は存在せず欠番である。

しかし、QPは、マーケティング認証(MA)の要件およびGMPの要件に従って、認証が行われる加盟国における有効な法律に従って、個々のバッチが製造され、チェックされていることを保証する責任がある。

デンマークの当局(DKMA)は、この上級管理責任を面白いやり方で強化する行動をとった、つまりCEOを引責辞任させたのである。

今まではQPに責任を着せがちだったが、PQS(Pharmaceutical Quality System)の最終責任はシニアマネジメントにあるということである。

Related post

Comment

  1. best allergy pill does allegra require a prescription prescription vs over the counter

  2. doctor prescribed allergy medication strongest over the counter allergy does benadryl make you sweat

  3. really strong sleeping pills buy phenergan 25mg

  4. prescription for sleep aids order meloset 3mg

  5. buy prednisone 20mg order prednisone 20mg generic

  6. order prednisone 20mg pills buy prednisone 10mg generic

  7. heartburn covered by medicaid where to buy avapro without a prescription

  8. best prescription medication for reflux coversyl sale

  9. antibiotics for pimple pills where to buy avlosulfon without a prescription dermatologist specializes in acne

  10. buy acne pills online aczone online buy acne treatments that work uk

  11. allergy medication primary name ventolin inhalator over the counter allergy pills over the counter

  12. anti nausea medication brand names natural ways to get rid of acid reflux

  13. best otc heartburn med order famotidine sale

  14. order accutane pills isotretinoin 10mg cheap oral isotretinoin 20mg

  15. isotretinoin 10mg brand cheap isotretinoin 20mg order accutane 20mg generic

  16. doctor sleep online free phenergan price

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

  18. what is the strongest sleeping pill strong dangerous sleeping pills

  19. amoxil 250mg over the counter buy amoxil 250mg without prescription buy amoxil tablets

  20. prescription sleep meds for elderly order provigil pill

  21. zithromax 500mg usa cheap zithromax buy azithromycin 500mg online cheap

  22. neurontin for sale gabapentin 600mg uk

  23. zithromax pill order zithromax 250mg generic order azithromycin 500mg online cheap

  24. gabapentin price order gabapentin 600mg

  25. brand azipro buy azithromycin tablets order azipro pill

  26. buy furosemide paypal purchase furosemide pill

  27. buy azithromycin sale azithromycin online order azithromycin 500mg cheap

  28. buy furosemide online cheap order generic furosemide

  29. buy prednisolone 5mg sale cheap prednisolone 40mg buy omnacortil no prescription

  30. order omnacortil 40mg brand prednisolone 40mg prednisolone price

  31. prednisone 5mg price buy prednisone 10mg online cheap

  32. amoxil 500mg tablet amoxicillin 1000mg us order generic amoxicillin 500mg

  33. order vibra-tabs for sale cost doxycycline 100mg

  34. amoxil 1000mg sale amoxil 500mg tablet purchase amoxicillin online cheap

  35. vibra-tabs for sale online vibra-tabs order online

  36. buy ventolin 2mg pills ventolin inhalator medication albuterol pill

  37. order ventolin 2mg online cheap order albuterol inhaler generic asthma pills

  38. order augmentin sale order augmentin without prescription

  39. augmentin 375mg sale augmentin 625mg price

  40. order levothroid online where to buy synthroid without a prescription levothroid pills

  41. buy synthroid 75mcg generic levothyroxine usa buy synthroid sale

  42. buy vardenafil 10mg sale how to buy vardenafil

  43. order levitra 20mg generic purchase levitra for sale

  44. purchase serophene pills clomid us order clomiphene 100mg without prescription

  45. order clomiphene 50mg pill buy clomiphene 100mg online where to buy clomiphene without a prescription

  46. purchase tizanidine pill zanaflex over the counter tizanidine over the counter

  47. tizanidine generic buy zanaflex medication tizanidine over the counter

  48. rybelsus drug buy semaglutide pills for sale oral rybelsus 14mg

  49. order rybelsus 14mg online rybelsus 14mg price order semaglutide 14 mg online cheap

  50. deltasone order online deltasone 40mg canada order deltasone 40mg sale

  51. order deltasone purchase prednisone generic buy prednisone 10mg online

  52. rybelsus pill rybelsus usa buy semaglutide pills for sale

  53. buy semaglutide online semaglutide 14mg brand semaglutide drug

  54. buy isotretinoin no prescription order isotretinoin 10mg for sale buy accutane 20mg sale

  55. order isotretinoin 10mg pill brand accutane 40mg purchase absorica generic

  56. buy asthma pills buy generic ventolin over the counter purchase albuterol inhalator generic

  57. buy amoxil 250mg pills cheap amoxicillin for sale amoxicillin 500mg pill

  58. buy generic amoxil for sale amoxil 500mg for sale amoxil order

  59. albuterol brand purchase ventolin sale oral ventolin 2mg

  60. buy augmentin sale augmentin ca amoxiclav usa

  61. azithromycin pills order azithromycin 500mg buy generic azithromycin over the counter

  62. purchase azithromycin for sale azithromycin 500mg cost azithromycin 250mg brand

  63. augmentin sale amoxiclav canada augmentin 375mg drug

  64. levothroid ca levothyroxine tablets synthroid 150mcg uk

  65. omnacortil 10mg tablet buy prednisolone 10mg cheap prednisolone 10mg

  66. oral prednisolone 20mg omnacortil 10mg cost omnacortil order online

  67. order levothroid pill buy levothyroxine pill buy generic levoxyl

  68. buy clomid 100mg online order clomid 100mg for sale clomiphene price

  69. neurontin price neurontin drug order neurontin for sale

  70. how to get gabapentin without a prescription generic gabapentin 100mg generic gabapentin 100mg

  71. clomiphene 100mg price buy clomid online cheap clomiphene where to buy

  72. sildenafil online order sildenafil online viagra online buy

  73. lasix 100mg tablet where to buy furosemide without a prescription buy lasix without prescription

  74. furosemide uk oral lasix 100mg furosemide cost

  75. overnight delivery viagra sildenafil 50mg brand viagra 100mg oral

  76. brand semaglutide 14mg rybelsus 14mg pills semaglutide price

  77. doxycycline oral how to buy doxycycline how to get doxycycline without a prescription

  78. Hi, I think your site might be having browser compatibility issues. When I look at your website in Safari, it looks fine but when opening in Internet Explorer, it has some overlapping. I just wanted to give you a quick heads up! Other then that, fantastic blog!

  79. order vibra-tabs sale acticlate brand buy doxycycline tablets

  80. semaglutide 14 mg us rybelsus online order semaglutide 14mg drug

  81. casino games free world series of poker online slots free

  82. buy generic vardenafil for sale levitra order levitra pill

  83. free slot machine games no deposit free spins casino casino world

  84. vardenafil 20mg without prescription cheap vardenafil order levitra for sale

  85. lyrica over the counter order lyrica 75mg online cost lyrica

  86. lyrica 75mg ca order generic lyrica generic lyrica 150mg

  87. buy plaquenil 400mg for sale buy plaquenil 200mg online buy hydroxychloroquine generic

  88. plaquenil price hydroxychloroquine us buy generic hydroxychloroquine 400mg

  89. order triamcinolone for sale buy aristocort 4mg pill aristocort 10mg price

  90. cost triamcinolone order triamcinolone 4mg triamcinolone price

  91. order cialis 5mg generic cheap cialis generic cialis 10mg brand

  92. order tadalafil 5mg for sale purchase tadalafil online cialis 5mg uk

  93. clarinex sale buy generic desloratadine buy desloratadine no prescription

  94. order desloratadine pill clarinex 5mg us clarinex 5mg usa

  95. cenforce tablet cenforce 100mg sale cenforce 100mg canada

  96. order cenforce 100mg for sale buy generic cenforce 50mg cenforce order

  97. buy claritin tablets purchase loratadine for sale claritin 10mg oral

  98. order loratadine 10mg pill claritin canada claritin pills

  99. order aralen 250mg sale aralen 250mg uk aralen 250mg brand

  100. chloroquine 250mg uk order chloroquine 250mg online aralen canada

  101. priligy 90mg cheap purchase misoprostol pills order cytotec online

  102. buy dapoxetine 60mg online order misoprostol sale misoprostol price

  103. order glucophage for sale order glycomet 500mg sale buy glycomet 1000mg without prescription

  104. orlistat cost generic diltiazem 180mg diltiazem pills

  105. order glucophage 500mg buy glucophage 1000mg online cheap buy glucophage 500mg generic

  106. orlistat 60mg canada diltiazem tablet diltiazem over the counter

  107. oral lipitor 10mg lipitor 20mg over the counter buy lipitor sale

  108. order amlodipine 5mg without prescription amlodipine 10mg canada buy generic amlodipine over the counter

  109. zovirax 400mg cheap order allopurinol 300mg sale order allopurinol 300mg for sale

  110. acyclovir sale zovirax 800mg ca buy generic zyloprim over the counter

  111. amlodipine cost order norvasc generic buy amlodipine 10mg online cheap

  112. zestril oral lisinopril over the counter zestril 10mg without prescription

  113. crestor us ezetimibe for sale online order zetia 10mg online cheap

  114. order crestor 10mg pills buy ezetimibe paypal ezetimibe online buy

  115. lisinopril 5mg canada purchase prinivil pill buy zestril 2.5mg pill

  116. purchase omeprazole without prescription oral omeprazole 10mg buy prilosec 20mg generic

  117. buy motilium 10mg pill domperidone uk buy sumycin online cheap

  118. brand domperidone 10mg domperidone order online tetracycline price

  119. buy prilosec no prescription buy omeprazole 10mg prilosec oral

  120. lopressor 100mg uk metoprolol 50mg ca purchase lopressor generic

  121. buy cyclobenzaprine 15mg lioresal cheap buy lioresal medication

  122. buy flexeril paypal baclofen price order baclofen online

  123. Thank you so much for providing individuals with an exceptionally breathtaking chance to read from this web site. It really is so lovely and packed with a lot of fun for me and my office peers to visit your web site nearly thrice in a week to read through the newest issues you will have. Of course, we’re certainly happy concerning the cool principles served by you. Selected 3 points on this page are really the most suitable we’ve ever had.

  124. buy lopressor paypal metoprolol 100mg ca brand lopressor

  125. buy atenolol 100mg online oral atenolol generic tenormin 100mg

  126. toradol 10mg pill order colchicine 0.5mg sale how to buy colchicine

  127. toradol 10mg oral buy ketorolac sale order colcrys 0.5mg generic

  128. order tenormin 50mg generic order atenolol 100mg online cheap tenormin generic

  129. buy generic depo-medrol online depo-medrol uk buy cheap generic methylprednisolone

  130. buy methylprednisolone no prescription buy medrol online where can i buy depo-medrol

  131. buy an essay online buy thesis paper how to write my thesis

  132. inderal 20mg cost clopidogrel oral clopidogrel brand

  133. buy inderal tablets clopidogrel 75mg for sale clopidogrel 75mg without prescription

  134. write thesis speechwriters buying an essay

  135. methotrexate for sale buy coumadin 5mg without prescription buy warfarin pills for sale

  136. purchase methotrexate for sale order methotrexate 10mg online cheap coumadin 5mg cheap

  137. meloxicam 7.5mg usa buy mobic 7.5mg pill celecoxib generic

  138. purchase reglan online purchase maxolon online buy cozaar 25mg pills

  139. how to get maxolon without a prescription buy metoclopramide 20mg generic losartan 50mg sale

  140. purchase mobic sale order mobic 15mg pill buy celebrex 200mg for sale

  141. flomax price tamsulosin pills celebrex 100mg over the counter

  142. tamsulosin 0.4mg without prescription celebrex 100mg over the counter celebrex medication

  143. order generic esomeprazole 40mg buy topiramate medication order topiramate 200mg generic

  144. buy generic nexium for sale purchase topiramate sale topamax 100mg usa

  145. buy generic zofran order zofran 8mg without prescription order spironolactone 100mg pills

  146. oral sumatriptan 25mg buy levaquin 500mg online levofloxacin cheap

  147. buy imitrex 25mg for sale order levofloxacin 250mg pill buy levofloxacin online

  148. buy zofran sale buy zofran without a prescription order spironolactone 100mg pill

  149. order zocor 10mg generic how to buy valtrex order valtrex 500mg without prescription

  150. where to buy avodart without a prescription purchase dutasteride pill order zantac 150mg

  151. buy cheap avodart ranitidine 150mg uk order ranitidine 300mg online

  152. simvastatin 20mg pills buy valacyclovir 500mg generic buy valacyclovir generic

  153. cost proscar 5mg proscar 5mg for sale diflucan 100mg tablet

  154. purchase ampicillin generic monodox online amoxil where to buy

  155. acillin brand buy ampicillin medication order amoxil

  156. order finasteride 5mg online cheap how to get fluconazole without a prescription purchase diflucan for sale

  157. cipro for sale online – keflex without prescription augmentin 375mg price

  158. order cipro 1000mg generic – order keflex 250mg online order augmentin 625mg online

  159. buy cipro 1000mg generic – buy septra online augmentin 625mg cheap

  160. buy cipro 500mg online cheap – buy generic cephalexin augmentin canada

  161. purchase metronidazole online cheap – cleocin canada brand azithromycin

  162. order metronidazole pill – cefaclor uk buy zithromax generic

  163. ciplox cheap – chloramphenicol price erythromycin 250mg cheap

  164. brand ciplox 500mg – amoxicillin 250mg drug
    erythromycin 500mg pill

  165. valacyclovir 1000mg usa – purchase nemasole generic order zovirax 400mg

  166. valacyclovir 1000mg generic – valtrex buy online buy zovirax medication

  167. ivermectin 3mg oral – sumycin brand buy sumycin sale

  168. ivermectin for humans walmart – how to get aczone without a prescription order tetracycline 500mg sale

  169. order metronidazole 400mg without prescription – oxytetracycline 250 mg cheap buy azithromycin 250mg without prescription

  170. brand metronidazole 400mg – buy generic cefaclor 500mg cost azithromycin

  171. buy ampicillin generic doxycycline order online cheap amoxicillin generic

  172. ampicillin without prescription ampicillin online order buy amoxil generic

  173. I like the valuable info you provide in your articles. I will bookmark your weblog and check again here regularly. I am quite certain I’ll learn plenty of new stuff right here! Good luck for the next!

  174. cheap furosemide 100mg – buy atacand 16mg pill buy generic capoten 25mg

  175. furosemide 100mg sale – coumadin price order capoten for sale

  176. buy glucophage 1000mg for sale – lamivudine drug lincocin uk

  177. buy generic retrovir for sale – zyloprim tablet order zyloprim sale

  178. buy metformin 1000mg for sale – lincomycin online lincocin 500mg pills

  179. zidovudine 300 mg canada – brand rulide 150 mg zyloprim price

  180. buy clozaril 50mg pill – frumil cost pepcid price

  181. buy clozaril pills for sale – purchase aceon pill famotidine tablet

  182. quetiapine price – order bupron SR for sale buy cheap generic eskalith

  183. order seroquel 100mg without prescription – buy seroquel generic cheap generic eskalith

  184. atarax 25mg ca – hydroxyzine over the counter purchase endep without prescription

  185. order anafranil 25mg sale – purchase amoxapine for sale buy sinequan 25mg pills

  186. anafranil 25mg pills – order citalopram 40mg online sinequan 25mg cheap

  187. buy hydroxyzine sale – buy sarafem 40mg for sale endep over the counter

  188. amoxicillin for sale online – cheap erythromycin buy ciprofloxacin pills

  189. purchase amoxiclav pill – buy cheap acillin where can i buy cipro

  190. buy clavulanate tablets – cipro sale brand ciprofloxacin 500mg

  191. cheap generic amoxil – order cephalexin 125mg for sale cheap ciprofloxacin

  192. clindamycin sale – buy cheap doxycycline cheap chloromycetin

  193. What Is Sugar Defender? Sugar Defender is a natural blood sugar support formula created by Tom Green. It is based on scientific breakthroughs and clinical studies.

  194. You are a very clever person!

  195. cleocin 150mg for sale – buy terramycin medication chloromycetin for sale online

  196. zithromax sale – tindamax buy online buy ciplox online cheap

  197. What Is Puravive? Puravive is a natural weight loss supplement that is known to boost the metabolic processes of the body.

  198. azithromycin 500mg price – tetracycline 500mg generic buy ciprofloxacin online cheap

  199. FitSpresso is a natural weight loss supplement that will help you maintain healthy body weight without having to deprive your body of your favorite food or take up exhausting workout routines.

  200. albuterol price – order seroflo online theophylline 400 mg over the counter

  201. stromectol coronavirus – ivermectin 6mg online buy cefaclor 250mg for sale

  202. buy ivermectin pills – order eryc 500mg generic buy cefaclor 250mg pill

  203. get allergy pills online – order promethazine 25mg without prescription theo-24 Cr 400 mg canada

  204. Hi my friend! I wish to say that this article is awesome, great written and include approximately all significant infos. I would like to look more posts like this .

  205. desloratadine online – beclamethasone price order ventolin 2mg online cheap

  206. Thanks for another informative site. Where else could I get that kind of information written in such an ideal means? I’ve a challenge that I am just now operating on, and I have been on the look out for such info.

  207. buy medrol for sale – buy singulair 5mg for sale astelin buy online

  208. cost desloratadine – beclamethasone buy online allergy tablets

  209. buy methylprednisolone tablets – order claritin sale buy astelin nasal spray for sale

TOP