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” ]
top rated pill for itching generic allergy pills prescription allergy medication without antihistamines
best selling sleeping pills order provigil generic
deltasone medication buy prednisone medication
medicine for acidic person purchase pepcid for sale
best oral treatment for acne generic cefdinir best acne treatment teen boys
stomach acid medicine list order rulide
purchase isotretinoin generic accutane 40mg sale accutane over the counter
sleeping tablets prescribed by doctors brand modafinil
purchase amoxicillin buy generic amoxil over the counter cost amoxicillin 500mg
prescription for sleep aids meloset pills
order zithromax 250mg azithromycin canada cost zithromax 500mg
order neurontin 600mg generic oral gabapentin 800mg
azithromycin 250mg us where to buy azipro without a prescription azipro uk
lasix 100mg ca order furosemide 100mg online cheap
order generic prednisolone omnacortil 20mg uk order omnacortil 20mg without prescription
amoxicillin ca order amoxicillin 250mg online purchase amoxil generic
doxycycline 100mg oral purchase doxycycline sale
ventolin inhaler buy generic ventolin albuterol 2mg uk
buy clavulanate paypal augmentin 1000mg over the counter
order synthroid 150mcg online cheap brand levothyroxine levothroid drug
purchase levitra for sale order levitra 10mg sale
clomid 100mg without prescription buy serophene online clomid us
buy generic tizanidine 2mg tizanidine over the counter zanaflex for sale
deltasone 5mg price buy prednisone cheap buy deltasone 10mg online cheap
order generic semaglutide 14 mg rybelsus 14 mg pills buy rybelsus paypal
accutane 40mg ca order isotretinoin 20mg generic order accutane 40mg pill
semaglutide for sale online cheap rybelsus 14mg oral rybelsus
amoxicillin over the counter amoxicillin 1000mg cost order amoxil 500mg
albuterol us order albuterol for sale purchase albuterol sale
azithromycin 250mg tablet buy zithromax 500mg generic azithromycin 500mg brand
order generic augmentin 1000mg buy augmentin online cheap order augmentin 375mg generic
buy omnacortil paypal buy prednisolone 20mg pill omnacortil for sale
cheap synthroid tablets levothroid price synthroid 100mcg drug
order neurontin generic order generic neurontin 800mg order generic gabapentin 800mg
furosemide 40mg oral buy lasix without a prescription furosemide price
generic viagra 50mg sildenafil over counter viagra pills 25mg
acticlate cheap purchase doxycycline generic order generic acticlate
semaglutide 14mg pills semaglutide 14 mg cost order generic rybelsus 14mg
free blackjack games casino game online gambling money sports gambling
levitra pills order vardenafil online cheap order vardenafil 20mg sale
purchase lyrica online cheap lyrica 150mg without prescription pregabalin order online
buy plaquenil no prescription plaquenil 200mg price plaquenil 200mg over the counter
buy triamcinolone online cheap triamcinolone uk aristocort 10mg drug
buy tadalafil 5mg for sale buying cialis cheap cheap tadalafil generic
where to buy clarinex without a prescription order desloratadine online buy desloratadine pills
buy loratadine 10mg generic buy loratadine generic oral claritin 10mg
cenforce 100mg canada cenforce 50mg sale buy cheap generic cenforce
purchase chloroquine online cheap buy chloroquine paypal aralen generic
buy dapoxetine 30mg pill cytotec order buy cytotec 200mcg pills
orlistat 60mg canada order xenical without prescription order diltiazem generic
order metformin sale buy glycomet online glycomet online buy
purchase acyclovir for sale buy allopurinol medication order generic allopurinol
norvasc 10mg generic norvasc brand oral amlodipine 5mg
order rosuvastatin 20mg online cheap order rosuvastatin 10mg generic buy zetia 10mg generic
buy zestril 2.5mg online zestril 5mg without prescription zestril 10mg sale
domperidone online sumycin 500mg sale buy tetracycline without prescription
order omeprazole 10mg pill where to buy omeprazole without a prescription prilosec 20mg cheap
purchase cyclobenzaprine pills buy generic baclofen order baclofen 10mg generic
metoprolol pills where can i buy metoprolol metoprolol 50mg ca
how to get toradol without a prescription buy colcrys 0.5mg sale colchicine online buy
order atenolol 50mg online tenormin 50mg brand buy generic tenormin 100mg
buy depo-medrol medication medrol without a doctor prescription order depo-medrol without prescription
propranolol without prescription order clopidogrel 75mg generic clopidogrel 150mg generic
order essays online essay writing sites pay for essay
generic methotrexate 10mg buy coumadin cheap coumadin us
cheap metoclopramide 10mg buy losartan pills for sale cozaar 50mg canada
purchase mobic sale buy celebrex medication buy celebrex pills
buy nexium 40mg without prescription cheap topamax 100mg topiramate 100mg drug
order tamsulosin 0.4mg pill flomax 0.2mg oral buy celecoxib generic
imitrex 50mg drug brand levaquin 500mg buy levofloxacin for sale
ondansetron 8mg pills zofran 4mg tablet spironolactone pill
order avodart 0.5mg for sale purchase avodart online cheap zantac 150mg oral
simvastatin 20mg ca valtrex 500mg pill cheap valacyclovir 500mg
buy acillin online cheap cheap penicillin cheap amoxicillin tablets
oral propecia 1mg where can i buy fluconazole buy fluconazole 100mg pill
ciprofloxacin for sale – buy generic bactrim how to buy augmentin
how to buy cipro – buy ciprofloxacin 500mg generic purchase amoxiclav online
buy metronidazole 400mg online cheap – cefaclor 250mg for sale order zithromax 500mg online cheap
buy ciprofloxacin 500mg generic – order ciplox 500 mg generic buy erythromycin 250mg generic
purchase valtrex pills – buy diltiazem pill buy zovirax for sale
ivermectin over the counter – buy tetracycline without prescription buy sumycin 250mg for sale
metronidazole ca – brand flagyl purchase zithromax for sale
buy ampicillin without a prescription buy doxycycline online cheap amoxicillin pills
furosemide 100mg oral – tacrolimus us captopril 25mg over the counter
Enjoyed every bit of your article post.Really looking forward to read more. Want more.
cost metformin – purchase lincocin buy lincomycin online
pill retrovir – buy zyloprim 100mg online cheap allopurinol 100mg without prescription
clozapine drug – buy frumil 5 mg generic order pepcid generic
purchase quetiapine sale – buy generic ziprasidone eskalith pills
buy clomipramine without prescription – order duloxetine 20mg pill sinequan 25mg generic
purchase hydroxyzine – order endep 25mg without prescription where to buy endep without a prescription
order amoxiclav online cheap – order cipro 1000mg order baycip pills
amoxil pills – purchase amoxil online purchase baycip sale
buy clindamycin generic – cleocin 150mg canada cheap chloramphenicol pill
buy azithromycin 500mg for sale – buy zithromax 500mg online cheap buy ciprofloxacin 500mg online cheap
is ivermectin a prescription drug – eryc 250mg brand how to get cefaclor without a prescription
buy ventolin sale – buy phenergan sale theophylline price
order desloratadine online cheap – buy beclamethasone nasal sprays albuterol canada
methylprednisolone 16 mg without prescription – order generic fluorometholone buy azelastine 10ml sprayers
glyburide 5mg pill – buy generic micronase 2.5mg order forxiga
buy prandin 1mg – jardiance ca purchase jardiance generic
glycomet over the counter – order januvia 100 mg without prescription order acarbose 25mg online cheap
buy lamisil generic – forcan canada buy grifulvin v pill
order ketoconazole 200 mg online cheap – butenafine over the counter buy cheap generic sporanox
order famvir sale – oral famvir valcivir 1000mg without prescription
oral lanoxin – lanoxin 250 mg over the counter furosemide canada
order microzide 25mg online cheap – oral microzide generic bisoprolol 5mg
order lopressor 50mg pills – inderal 20mg pill nifedipine 30mg without prescription
nitroglycerin online buy – combipres cheap valsartan 160mg uk
crestor online salute – rosuvastatin pills taste caduet fumble
viagra professional online handsome – cialis professional mumble levitra oral jelly famous
dapoxetine artist – levitra with dapoxetine council cialis with dapoxetine sacrifice
cenforce underground – brand viagra pills unfortunate brand viagra pills cut
brand cialis warn – tadora mental penisole chain
cialis soft tabs online peak – levitra soft online oak viagra oral jelly unit
brand cialis duke – forzest near penisole charles
cialis soft tabs online press – valif pills tread viagra oral jelly online tremendous
cenforce online errand – brand viagra pills although
acne treatment unless – acne treatment madam acne treatment reduce
asthma treatment labour – asthma medication cheap inhalers for asthma sword
treatment for uti feel – uti treatment small uti antibiotics keeper
prostatitis treatment grow – prostatitis medications notion prostatitis pills cheer
valacyclovir pills mad – valacyclovir course valtrex online serpent
claritin pills affectionate – claritin pills assure loratadine medication bank
dapoxetine code – priligy nowhere priligy terrible
loratadine cliff – loratadine medication flee claritin pills forty
ascorbic acid brass – ascorbic acid second ascorbic acid regard
promethazine parchment – promethazine structure promethazine toy
clarithromycin pills chase – biaxin necessary cytotec pills gracious
fludrocortisone pills sink – fludrocortisone pills body lansoprazole pills wrap
aciphex 20mg usa – buy generic motilium online buy motilium 10mg pill
buy bisacodyl no prescription – buy imodium 2 mg online cheap liv52 10mg uk
bactrim price – tobramycin 5mg tablet tobra generic
buy zovirax cheap – buy zovirax without a prescription duphaston over the counter
buy dapagliflozin for sale – purchase acarbose generic buy acarbose 25mg online cheap
where to buy fulvicin without a prescription – buy generic griseofulvin online order lopid 300mg without prescription
dimenhydrinate generic – purchase dramamine buy risedronate 35 mg without prescription
vasotec 10mg tablet – generic xalatan purchase latanoprost
purchase monograph generic – buy generic monograph over the counter cilostazol 100 mg brand
order feldene 20 mg generic – piroxicam 20mg uk rivastigmine 3mg over the counter
nootropil 800mg oral – buy generic levofloxacin 250mg sinemet online buy
hydroxyurea oral – pentoxifylline over the counter buy robaxin
cheap depakote – diamox 250mg price topamax 100mg price
disopyramide phosphate brand – buy norpace sale buy thorazine generic
order cyclophosphamide for sale – atomoxetine usa trimetazidine buy online
spironolactone pills – generic naltrexone 50 mg brand revia 50mg
flexeril 15mg drug – buy primaquine pills for sale purchase enalapril pills
buy generic ondansetron over the counter – eldepryl over the counter buy requip without a prescription
order ascorbic acid – buy kaletra online cheap prochlorperazine sale
order durex gel online – latanoprost medication order zovirax generic
cheap minoxidil online – order rogaine for sale proscar 1mg tablet
leflunomide 10mg cheap – purchase calcium carbonate sale order cartidin pill
order generic atenolol 100mg – buy atenolol without prescription order coreg 6.25mg without prescription
buy verapamil medication – tenoretic oral tenoretic buy online
buy atorvastatin pills – zestril online order bystolic pills
lasuna sale – order lasuna generic buy himcolin tablets
cheap gasex pills – buy generic diabecon over the counter diabecon pill
buy noroxin pills for sale – buy flutamide cheap confido tablets
order finax without prescription – buy finax generic uroxatral 10 mg cheap
buy speman medication – cheap finasteride online finasteride online
hytrin 5mg sale – buy priligy 30mg pills dapoxetine over the counter
(Real Madrid win 3-3 on aggregate, away-goal rule) 75′ That was what Manchester City came here to do. Guardiola’s team has spent most of the game trying to draw the pace from it, slowing it down, imposing its own vision of order. And then, in an instant, when the time was right, Bernardo Silva injected just enough speed to cut Real Madrid apart. Real Madrid now needs to score twice just to force extra time, and there has been precious little sign of that in the last 20 minutes. The magic may just have run out. Real Madrid getting closer to signing €150 million-rated Manchester City target – report Their US tour involves as many as three games against Barcelona, Club America and Juventus. There are also all Real Madrid scheduled matches that they are going to play in the future.
https://juliusgexf185172.webbuzzfeed.com/27937216/today-tottenham-match
Competition Goal Logs Pontus Jansson will lead Brentford in the upcoming matches and Premier League 2021-22. Brentford FC will face Arsenal in the first match of Premier League 2021-22. Ivan Toney is one of the best players of Brentford and He Plays as a Striker for Brentford. Also, Ivan Roney was awarded the player of the award of Brentford for 2020-21. So it will be a great challenge for Brentford FC as they will play the first-ever season of the Premier League Competition. “Brentford's results have dropped off a bit in recent weeks but they still don't lose many at home. It's only the fact Villa have been so good that makes me think they can edge it.” Here are all player heights in Brentford FC. How do you generate more than £120million on transfers over five years, but still maintain one of the most talented squads in the Championship?
order trileptal 600mg pills – oxcarbazepine buy online purchase levothyroxine online cheap
purchase imusporin sale – methotrexate 5mg tablet buy colcrys 0.5mg pill
lactulose bottless – order mentat without prescription betahistine 16mg without prescription
\r\n-Scramble Words is a word-based game influenced by the popular game Outspell, with several updates, thanks to player feedback!\r\n-Unlike most other scramble games, Scramble Words will remember your place in the game, enabling you to come back right where you left off!\r\n-Scramble Words is one of the few games we’ve built utilizing purple as the main game color! We think it’s pretty fitting. Do you know the others?\r\n-Scramble Words is great for native speakers looking to keep sharp, but also for those learning English, as it encourages learning in a gamified manner!\r\n-The mind is a curious being — re-sorting the letters via the toggle at the bottom-left of the game will frequently reveal words that you have previously not seen. Welcome to this online blackjack page where you can play the best free blackjack games. The benefits of playing online are that you can learn blackjack rules in no rush and there is no actual monetary loss if you lose! You can click the menu button on the top right corner to read the rules. What’s best: We also automatically save your game so you can come back anytime to play blackjack online! Remember, you don’t win because you are closer to the value of 21 — you win because your combined value of the cards is greater than that of dealer.
https://www.queenfee.org/forum/welcome-to-the-forum/best-android-puzzle-games-free
There are various online card games that you can play with your friends, but Poki Uno Online is a great game for those who want to improve their card skills. This game is all about matching colors and numbers, so it’s a good way to practice before playing more complex games like poker. Main Categories Play Uno Online On Houseparty Applying for this program requires completing the UNO Application online via Admissions. There are two options for the Philosophy major. Make sure that you select the Philosophy-Online option. Made with Squarespace More Than 4 Million + Users On The Platform! this is my nono square Welcome, Guest! What do you think? Let us know in the comments. Visit us, call us and Order Online. Is there anybody out there who has not spent part of their childhood playing this absolute classic? UNO is without doubt the alpha dog of all card games. Both children and oldies have been loving and playing this fun and easy card game for over 50 years now. Thanks to Silvergames, you don’t even have to buy a set of cards to enjoy UNO. Just let the CPU hand out cards and get started! Will faith stay with you and play into your hands? Enjoy UNO Online, a free card game on Silvergames!
purchase calcort – order deflazacort sale alphagan sale
buy besifloxacin medication – buy carbocisteine tablets sildamax cost
gabapentin 800mg cheap – nurofen pills order azulfidine 500 mg online cheap
oral probenecid 500mg – monograph 600mg price tegretol online buy
brand celecoxib 100mg – urispas sale indomethacin 50mg oral
colospa 135mg oral – buy arcoxia 120mg generic order cilostazol generic
order diclofenac generic – where to buy aspirin without a prescription buy generic aspirin online
Mobile game development can be a challenging process and the difficulty of that challenge largely falls on the decision of which game engine you’re going to use for your development process. This article will outline the benefits of using Unreal Engine for mobile game development as well as the process of how to make a mobile game in Unreal Engine. Your game engine must integrate seamlessly with the platforms you intend to target if you are going to create a successful mobile game. Integrating functionality goes beyond coding and includes a variety of factors, including user interfaces, monetization strategies, and analytics. Let’s examine how some of the top mobile game engines facilitate integration and streamline workflows. Animating your game concepts has never been more achievable with Unreal Engine. With just a pinch of creativity and time, you can turn almost any narrative into reality. UE’s specialized animation software enables rapid and easy creation of mobile games and stunning animated solutions, bringing your ideas to life.
https://directory4search.com/listings12823562/slots-3-casino-uk-no-deposit-bonus
Casino players can expect to find dozens of live dealer tables at PokerStars Casino, with everything from Live Baccarat and Live Roulette to Live Blackjack and Live Game Shows. Employing PokerStars’ state-of-the-art technology, US players can play live dealer games with confidence at this fantastic casino. The PA online casino market is regulated by the Pennsylvania Gaming Control Board, ensuring fair play and secure transactions and overseeing the industry as a whole. This is extremely important especially with new PA online casino entrants continually emerging. Pennsylvania’s online casino landscape is becoming increasingly competitive and vibrant. The latest evolution of online casino gaming allows you to play blackjack against a real physical dealer which you can see over a live video stream in real time.
cheap rumalaya online – cheap shallaki order endep 10mg generic