FDAの査察官は優秀か

筆者がある一部上場企業でFDA査察に立ち会った際、事前の打合せで当該企業の社長から次のような質問を受けた。
「FDAの査察官はそんなに優秀なのか。はたしてFDAの査察官の指摘の通りにすれば品質が良くなるのか。だってFDAの査察官は、医薬品を製造している訳ではなく、医療機器を設計製造している訳ではないじゃないか。」
疑問はごもっともである。
しかしである。当局の査察官や我々のような監査を実施するコンサルタントは、多くの企業のQMSを調査し、製造所を視察してきている。
そのため、ベンチマーク(比較)が出来るのである。
すなわち、他社で実施していることが当該企業でできていなければ、それはリスクとなる。
また、他社で発生した逸脱や回収事案などについても、当該企業が気付いていない場合、やはりリスクであろう。

このように査察や監査はリスクを見付け出すことに意味があるのである。

筆者がしばしば目にするのは、監査において過去のミスや問題のみを指摘しているケースである。
もちろんそれらは重要ではある。しかしながら、過去のミスや問題は、監査ではなくQCやQAが解決しておくべきである。
監査は問題を見付けるものではなく、問題がないことを確認するのが本来の監査なのである。

上述の通り、監査ではリスクを発見しなければならない。
しかしながら、生え抜きの従業員ではおそらくリスクを見付けることは不可能であろう。
なぜならば、他社のやり方を知らないためである。
また自社のやり方を“是”としているため、足りない事項や危ない事項には気が付かないのである。

多くの企業では、監査チェックリストに従って、監査を実施し、問題点がないかどうかを探している。
また監査員の教育も、集合教育を実施しているのみである。
これでは、百戦錬磨の査察官には太刀打ち出来ない。
では、監査員を養成するにはどうすれば良いのであろうか。
それは、供給者監査を実施し、経験を積むことである。
その際に、品質の悪い企業ばかり監査するのではなく、品質の良い企業にも監査するべきである。
場数を踏むことにより、ベンチマークが可能となるのである。
井の中の蛙では、FDAの査察官のように自社のリスクを指摘することは不可能である。

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. top rated pill for itching generic allergy pills prescription allergy medication without antihistamines

  2. best selling sleeping pills order provigil generic

  3. deltasone medication buy prednisone medication

  4. medicine for acidic person purchase pepcid for sale

  5. best oral treatment for acne generic cefdinir best acne treatment teen boys

  6. stomach acid medicine list order rulide

  7. purchase isotretinoin generic accutane 40mg sale accutane over the counter

  8. sleeping tablets prescribed by doctors brand modafinil

  9. purchase amoxicillin buy generic amoxil over the counter cost amoxicillin 500mg

  10. prescription for sleep aids meloset pills

  11. order zithromax 250mg azithromycin canada cost zithromax 500mg

  12. order neurontin 600mg generic oral gabapentin 800mg

  13. azithromycin 250mg us where to buy azipro without a prescription azipro uk

  14. lasix 100mg ca order furosemide 100mg online cheap

  15. order generic prednisolone omnacortil 20mg uk order omnacortil 20mg without prescription

  16. amoxicillin ca order amoxicillin 250mg online purchase amoxil generic

  17. doxycycline 100mg oral purchase doxycycline sale

  18. ventolin inhaler buy generic ventolin albuterol 2mg uk

  19. buy clavulanate paypal augmentin 1000mg over the counter

  20. order synthroid 150mcg online cheap brand levothyroxine levothroid drug

  21. purchase levitra for sale order levitra 10mg sale

  22. clomid 100mg without prescription buy serophene online clomid us

  23. buy generic tizanidine 2mg tizanidine over the counter zanaflex for sale

  24. deltasone 5mg price buy prednisone cheap buy deltasone 10mg online cheap

  25. order generic semaglutide 14 mg rybelsus 14 mg pills buy rybelsus paypal

  26. accutane 40mg ca order isotretinoin 20mg generic order accutane 40mg pill

  27. semaglutide for sale online cheap rybelsus 14mg oral rybelsus

  28. amoxicillin over the counter amoxicillin 1000mg cost order amoxil 500mg

  29. albuterol us order albuterol for sale purchase albuterol sale

  30. azithromycin 250mg tablet buy zithromax 500mg generic azithromycin 500mg brand

  31. order generic augmentin 1000mg buy augmentin online cheap order augmentin 375mg generic

  32. buy omnacortil paypal buy prednisolone 20mg pill omnacortil for sale

  33. cheap synthroid tablets levothroid price synthroid 100mcg drug

  34. order neurontin generic order generic neurontin 800mg order generic gabapentin 800mg

  35. furosemide 40mg oral buy lasix without a prescription furosemide price

  36. generic viagra 50mg sildenafil over counter viagra pills 25mg

  37. acticlate cheap purchase doxycycline generic order generic acticlate

  38. semaglutide 14mg pills semaglutide 14 mg cost order generic rybelsus 14mg

  39. free blackjack games casino game online gambling money sports gambling

  40. levitra pills order vardenafil online cheap order vardenafil 20mg sale

  41. purchase lyrica online cheap lyrica 150mg without prescription pregabalin order online

  42. buy plaquenil no prescription plaquenil 200mg price plaquenil 200mg over the counter

  43. buy triamcinolone online cheap triamcinolone uk aristocort 10mg drug

  44. buy tadalafil 5mg for sale buying cialis cheap cheap tadalafil generic

  45. where to buy clarinex without a prescription order desloratadine online buy desloratadine pills

  46. buy loratadine 10mg generic buy loratadine generic oral claritin 10mg

  47. cenforce 100mg canada cenforce 50mg sale buy cheap generic cenforce

  48. purchase chloroquine online cheap buy chloroquine paypal aralen generic

  49. buy dapoxetine 30mg pill cytotec order buy cytotec 200mcg pills

  50. orlistat 60mg canada order xenical without prescription order diltiazem generic

  51. order metformin sale buy glycomet online glycomet online buy

  52. purchase acyclovir for sale buy allopurinol medication order generic allopurinol

  53. norvasc 10mg generic norvasc brand oral amlodipine 5mg

  54. order rosuvastatin 20mg online cheap order rosuvastatin 10mg generic buy zetia 10mg generic

  55. buy zestril 2.5mg online zestril 5mg without prescription zestril 10mg sale

  56. domperidone online sumycin 500mg sale buy tetracycline without prescription

  57. order omeprazole 10mg pill where to buy omeprazole without a prescription prilosec 20mg cheap

  58. purchase cyclobenzaprine pills buy generic baclofen order baclofen 10mg generic

  59. metoprolol pills where can i buy metoprolol metoprolol 50mg ca

  60. how to get toradol without a prescription buy colcrys 0.5mg sale colchicine online buy

  61. order atenolol 50mg online tenormin 50mg brand buy generic tenormin 100mg

  62. buy depo-medrol medication medrol without a doctor prescription order depo-medrol without prescription

  63. propranolol without prescription order clopidogrel 75mg generic clopidogrel 150mg generic

  64. order essays online essay writing sites pay for essay

  65. generic methotrexate 10mg buy coumadin cheap coumadin us

  66. cheap metoclopramide 10mg buy losartan pills for sale cozaar 50mg canada

  67. purchase mobic sale buy celebrex medication buy celebrex pills

  68. buy nexium 40mg without prescription cheap topamax 100mg topiramate 100mg drug

  69. order tamsulosin 0.4mg pill flomax 0.2mg oral buy celecoxib generic

  70. imitrex 50mg drug brand levaquin 500mg buy levofloxacin for sale

  71. ondansetron 8mg pills zofran 4mg tablet spironolactone pill

  72. order avodart 0.5mg for sale purchase avodart online cheap zantac 150mg oral

  73. simvastatin 20mg ca valtrex 500mg pill cheap valacyclovir 500mg

  74. buy acillin online cheap cheap penicillin cheap amoxicillin tablets

  75. oral propecia 1mg where can i buy fluconazole buy fluconazole 100mg pill

  76. ciprofloxacin for sale – buy generic bactrim how to buy augmentin

  77. how to buy cipro – buy ciprofloxacin 500mg generic purchase amoxiclav online

  78. buy metronidazole 400mg online cheap – cefaclor 250mg for sale order zithromax 500mg online cheap

  79. buy ciprofloxacin 500mg generic – order ciplox 500 mg generic buy erythromycin 250mg generic

  80. purchase valtrex pills – buy diltiazem pill buy zovirax for sale

  81. ivermectin over the counter – buy tetracycline without prescription buy sumycin 250mg for sale

  82. metronidazole ca – brand flagyl purchase zithromax for sale

  83. buy ampicillin without a prescription buy doxycycline online cheap amoxicillin pills

  84. furosemide 100mg oral – tacrolimus us captopril 25mg over the counter

  85. Enjoyed every bit of your article post.Really looking forward to read more. Want more.

  86. cost metformin – purchase lincocin buy lincomycin online

  87. pill retrovir – buy zyloprim 100mg online cheap allopurinol 100mg without prescription

  88. clozapine drug – buy frumil 5 mg generic order pepcid generic

  89. purchase quetiapine sale – buy generic ziprasidone eskalith pills

  90. buy clomipramine without prescription – order duloxetine 20mg pill sinequan 25mg generic

  91. purchase hydroxyzine – order endep 25mg without prescription where to buy endep without a prescription

  92. order amoxiclav online cheap – order cipro 1000mg order baycip pills

  93. amoxil pills – purchase amoxil online purchase baycip sale

  94. buy clindamycin generic – cleocin 150mg canada cheap chloramphenicol pill

  95. buy azithromycin 500mg for sale – buy zithromax 500mg online cheap buy ciprofloxacin 500mg online cheap

  96. is ivermectin a prescription drug – eryc 250mg brand how to get cefaclor without a prescription

  97. buy ventolin sale – buy phenergan sale theophylline price

  98. order desloratadine online cheap – buy beclamethasone nasal sprays albuterol canada

  99. methylprednisolone 16 mg without prescription – order generic fluorometholone buy azelastine 10ml sprayers

  100. glyburide 5mg pill – buy generic micronase 2.5mg order forxiga

  101. buy prandin 1mg – jardiance ca purchase jardiance generic

  102. glycomet over the counter – order januvia 100 mg without prescription order acarbose 25mg online cheap

  103. buy lamisil generic – forcan canada buy grifulvin v pill

  104. order ketoconazole 200 mg online cheap – butenafine over the counter buy cheap generic sporanox

  105. order famvir sale – oral famvir valcivir 1000mg without prescription

  106. oral lanoxin – lanoxin 250 mg over the counter furosemide canada

  107. order microzide 25mg online cheap – oral microzide generic bisoprolol 5mg

  108. order lopressor 50mg pills – inderal 20mg pill nifedipine 30mg without prescription

  109. nitroglycerin online buy – combipres cheap valsartan 160mg uk

  110. crestor online salute – rosuvastatin pills taste caduet fumble

  111. viagra professional online handsome – cialis professional mumble levitra oral jelly famous

  112. dapoxetine artist – levitra with dapoxetine council cialis with dapoxetine sacrifice

  113. cenforce underground – brand viagra pills unfortunate brand viagra pills cut

  114. brand cialis warn – tadora mental penisole chain

  115. cialis soft tabs online peak – levitra soft online oak viagra oral jelly unit

  116. brand cialis duke – forzest near penisole charles

  117. cialis soft tabs online press – valif pills tread viagra oral jelly online tremendous

  118. cenforce online errand – brand viagra pills although

  119. acne treatment unless – acne treatment madam acne treatment reduce

  120. asthma treatment labour – asthma medication cheap inhalers for asthma sword

  121. treatment for uti feel – uti treatment small uti antibiotics keeper

  122. prostatitis treatment grow – prostatitis medications notion prostatitis pills cheer

  123. valacyclovir pills mad – valacyclovir course valtrex online serpent

  124. claritin pills affectionate – claritin pills assure loratadine medication bank

  125. dapoxetine code – priligy nowhere priligy terrible

  126. loratadine cliff – loratadine medication flee claritin pills forty

  127. ascorbic acid brass – ascorbic acid second ascorbic acid regard

  128. promethazine parchment – promethazine structure promethazine toy

  129. clarithromycin pills chase – biaxin necessary cytotec pills gracious

  130. fludrocortisone pills sink – fludrocortisone pills body lansoprazole pills wrap

  131. aciphex 20mg usa – buy generic motilium online buy motilium 10mg pill

  132. buy bisacodyl no prescription – buy imodium 2 mg online cheap liv52 10mg uk

  133. bactrim price – tobramycin 5mg tablet tobra generic

  134. buy zovirax cheap – buy zovirax without a prescription duphaston over the counter

  135. buy dapagliflozin for sale – purchase acarbose generic buy acarbose 25mg online cheap

  136. where to buy fulvicin without a prescription – buy generic griseofulvin online order lopid 300mg without prescription

  137. dimenhydrinate generic – purchase dramamine buy risedronate 35 mg without prescription

  138. vasotec 10mg tablet – generic xalatan purchase latanoprost

TOP