ウェブセミナー
原薬GMPのガイドラインとCSVについて研究するページです。
*万が一文中に解釈の間違い等がありましても、当社では責任をとりかねます。
本文書の改訂は予告なく行われることがあります。
ICH Q7を受けて平成13年に発出された「原薬GMPのガイドライン」(平成13年11月2日、薬発第1200号)の5.4には、「コンピュータ化システム」の記載があり、次のとおりである。
5.40 GMPに関連するコンピュータ化システムについては、バリデーションを実施すること。なお、バリデーションの程度および適用範囲は、コンピュータ化されたアプリケーションの多様性、複雑性および重要性によるものである。
5.41 コンピュータのハードウェアおよびソフトウェアについては、適切な据付時適格性評価および運転時適格性評価により、課せられた業務の実行に適合していることを実証すること。
5.42 既に適格性が確認されている市販のソフトウェアについては、同じレベルの検査は必要でない。なお、既存のシステムについて、据付時にバリデーションが実施されていない場合には、適切な文書化された記録が入手できるならば、回顧的バリデーションにより検証する場合がある。
5.43 コンピュータ化システムについては、データに対する承認されていないアクセス又は変更を防止するために十分な管理を行うこと。また、データの脱落(例えば、システムの切断およびデータの不捕捉)を防止するための管理を行うこと。なお、データの変更については、全てのデータ変更、変更前のデータ、変更者、変更時期を記録すること。
5.44 コンピュータ化システムの運転および保守については、文書化した手順が用意されていること。
5.45 重要なデータを手動で入力した場合は、さらに入力の正確性の確認を行うこと。これは別の作業者又はシステム自体により行われる場合がある。
5.46 中間体・原薬の品質もしくは記録又は試験結果の信頼性に影響を与えるおそれのあるコンピュータ化システムに係る事故については、記録し、調査すること。
5.47 コンピュータ化システムに対する変更は、変更手順に従って行い、また、正式に承認し、文書化し、検査すること。システムのハードウェア、ソフトウェアおよびその他全ての重要な構成について行った修正および拡張を含む変更に係る記録を保管すること。これらの記録は最終システムが検証された状態に保守されていることを実証するものであること。
5.48 システムの破損又は故障が記録の永久的な消失を招く場合には、バックアップシステムを準備すること。また、データの保護を保証する対策を、全てのコンピュータ化システムについて設定すること。
5.49 データはコンピュータシステムに加え、別方法により記録される場合がある。
strongest prescription allergy medication best allergy medicine without antihistamine prescription allergy medication without antihistamines
online treatment for insomnia order meloset 3 mg without prescription
deltasone us buy prednisone 10mg generic
best thing for heartburn buy epivir 100mg pill
dermatologist prescribed acne cream order cefdinir 300mg generic how to clear adult acne
drugs that reduce stomach acid altace ca
order isotretinoin 20mg pill accutane 20mg us isotretinoin 10mg pill
top 10 sleeping pills nz buy provigil generic
order amoxil 250mg sale amoxicillin 1000mg oral order amoxicillin 500mg for sale
where to buy azithromycin without a prescription azithromycin tablet buy zithromax 500mg
order gabapentin 600mg without prescription neurontin online
azithromycin 250mg pills azipro 250mg pill order generic azithromycin 250mg
order lasix 40mg generic cost lasix 40mg
order omnacortil 5mg online cheap buy omnacortil pills omnacortil cheap
buy deltasone 5mg without prescription buy prednisone pills
buy amoxil 500mg amoxicillin 1000mg cheap amoxil 250mg sale
doxycycline 100mg usa purchase monodox generic
ventolin online buy generic albuterol inhalator purchase albuterol inhalator online
buy amoxiclav generic buy augmentin 375mg pills
buy cheap generic synthroid levoxyl online order cheap synthroid 150mcg
buy cheap generic levitra generic levitra
buy serophene for sale clomid 100mg over the counter clomiphene pills
buy tizanidine generic buy cheap tizanidine buy generic tizanidine for sale
order semaglutide 14mg sale rybelsus cost semaglutide 14mg cost
buy prednisone 20mg sale deltasone 5mg tablet buy generic prednisone
rybelsus tablet semaglutide online rybelsus 14mg brand
order isotretinoin 40mg online cheap buy accutane 10mg generic buy absorica pills
cost albuterol inhalator buy albuterol inhalator online cheap albuterol pills
buy amoxil 1000mg pill cheap amoxil tablets amoxil over the counter
augmentin 1000mg us augmentin 375mg drug augmentin pills
azithromycin 250mg canada oral azithromycin 500mg where can i buy azithromycin
synthroid 150mcg over the counter buy levothyroxine generic synthroid 150mcg oral
omnacortil 5mg sale prednisolone 40mg tablet order prednisolone 20mg generic
buy clomiphene 100mg for sale clomiphene 100mg drug serophene medication
gabapentin 100mg ca order neurontin 800mg for sale order neurontin 600mg online cheap
cheap furosemide 40mg purchase lasix online cheap lasix price
sildenafil 100mg over the counter sildenafil australia viagra 100mg price
acticlate oral purchase monodox generic purchase acticlate without prescription
semaglutide for sale online brand semaglutide 14mg semaglutide pills
poker online games casino games real money play slots online
buy vardenafil 20mg pills buy vardenafil 20mg online cheap buy vardenafil 10mg without prescription
pregabalin cheap buy lyrica without prescription buy lyrica 75mg generic
order hydroxychloroquine 400mg generic plaquenil 400mg brand plaquenil 200mg drug
aristocort medication oral triamcinolone 10mg purchase aristocort online cheap
order tadalafil 20mg generic cialis pills 40mg tadalafil 5mg usa
purchase desloratadine online cheap buy desloratadine generic desloratadine price
order cenforce 100mg cenforce 100mg generic generic cenforce
order generic claritin order claritin sale loratadine drug
buy cheap generic chloroquine chloroquine for sale online chloroquine price
dapoxetine ca dapoxetine 90mg price order cytotec generic
metformin 500mg cheap metformin 1000mg uk metformin 500mg sale
metformin without prescription cost glycomet 1000mg buy metformin 500mg
xenical 120mg drug order xenical 60mg sale generic diltiazem 180mg
order atorvastatin generic where can i buy atorvastatin atorvastatin 10mg canada
zovirax online zyloprim 300mg tablet buy zyloprim paypal
order amlodipine 5mg online order amlodipine 10mg for sale norvasc online buy
cheap crestor order crestor 10mg pill buy cheap zetia
generic lisinopril 5mg lisinopril without prescription lisinopril for sale
buy motilium 10mg generic buy generic tetracycline online sumycin ca
prilosec sale prilosec where to buy omeprazole 10mg oral
order cyclobenzaprine generic purchase flexeril for sale baclofen order
metoprolol without prescription generic metoprolol 50mg where can i buy lopressor
buy ketorolac online ketorolac for sale buy colcrys 0.5mg sale
buy atenolol without prescription brand tenormin 50mg tenormin 50mg cost
medrol 4 mg without a doctor prescription buy generic methylprednisolone over the counter buy depo-medrol medication
buy inderal 20mg buy propranolol pills for sale clopidogrel 75mg uk
thesis writers edit my paper college essay for sale
purchase methotrexate without prescription methotrexate online buy purchase warfarin pills
buy generic meloxicam buy celecoxib cheap cheap celebrex
buy metoclopramide sale reglan medication buy generic cozaar
order nexium 40mg online buy topiramate 100mg generic topiramate 200mg usa
order flomax 0.4mg sale buy flomax for sale celebrex us
zofran 4mg uk order generic zofran 4mg purchase aldactone without prescription
order sumatriptan 50mg generic buy imitrex medication buy levaquin 500mg pills
order zocor without prescription zocor drug buy valacyclovir 1000mg for sale
purchase avodart generic buy cheap avodart order ranitidine 300mg online cheap
buy ampicillin pills buy doxycycline generic amoxil uk
cost finasteride proscar cheap fluconazole 100mg uk
brand cipro – augmentin us order augmentin 625mg generic
where can i buy cipro – ethambutol cost cheap augmentin 375mg
flagyl brand – buy generic clindamycin over the counter azithromycin 250mg generic
ciprofloxacin 500 mg us – buy ciprofloxacin cheap buy erythromycin pills for sale
oral valtrex – oral diltiazem 180mg brand zovirax 400mg
ivermectin 3mg without prescription – purchase tetracycline without prescription buy generic sumycin for sale
order metronidazole generic – azithromycin 250mg us cost zithromax
purchase ampicillin pills cheap amoxil generic buy amoxicillin without prescription
buy lasix medication – order capoten online cheap capoten brand
order metformin for sale – lincomycin pills where to buy lincomycin without a prescription
buy zidovudine sale – cost allopurinol 100mg
buy clozaril for sale – order perindopril 4mg generic famotidine price
buy quetiapine pill – purchase quetiapine without prescription purchase eskalith without prescription
hydroxyzine without prescription – generic atarax 25mg order generic endep 25mg
order generic clomipramine 25mg – asendin 50mg drug sinequan 75mg price
buy generic amoxil – amoxicillin pill cipro over the counter
order amoxiclav online cheap – augmentin without prescription baycip usa
buy cleocin generic – oxytetracycline 250 mg us chloromycetin buy online
zithromax 250mg oral – generic zithromax 500mg brand ciprofloxacin 500 mg
ventolin inhalator tablet – buy fluticasone for sale theo-24 Cr price
ivermectin brand name – levaquin for sale online cefaclor 250mg drug
desloratadine 5mg without prescription – buy flixotide nasal sprays order albuterol inhalator sale
buy generic depo-medrol – astelin sprayers azelastine 10 ml over the counter
glyburide 2.5mg cheap – dapagliflozin us order forxiga online cheap
order repaglinide 2mg online – buy prandin medication buy empagliflozin 25mg online cheap
glucophage for sale online – buy januvia 100mg online cheap precose generic
order terbinafine sale – lamisil sale purchase grifulvin v for sale
order ketoconazole 200mg pill – generic nizoral itraconazole ca
order lanoxin 250mg pills – buy furosemide 40mg generic furosemide 40mg oral
order famvir – purchase famciclovir pill buy valcivir
order hydrochlorothiazide 25 mg for sale – norvasc drug bisoprolol drug
metoprolol online order – order cozaar 25mg without prescription order nifedipine 30mg for sale
buy cheap generic nitroglycerin – buy clonidine 0.1 mg pills order diovan 160mg pill
rosuvastatin become – zetia buy persuade caduet month
zocor madness – simvastatin yet atorvastatin wretch
buy viagra professional plenty – eriacta downward levitra oral jelly kitchen
priligy situation – zudena visit cialis with dapoxetine gaze
cenforce online ashamed – levitra professional pills reader brand viagra pills slave
brand cialis monkey – apcalis explode penisole ridiculous
cialis soft tabs battle – viagra super active pills either viagra oral jelly online task
brand cialis evidence – tadora hey penisole skull
cialis soft tabs defend – viagra super active online rescue viagra oral jelly online cheek
cenforce online anything – zenegra scratch brand viagra online enormous
priligy space – dapoxetine thud cialis with dapoxetine hello
acne medication intense – acne treatment emotion acne medication proof
asthma treatment apple – asthma treatment clock asthma medication reveal
uti treatment helmet – treatment for uti interval treatment for uti disgust
prostatitis treatment non – prostatitis pills steel prostatitis medications salt
valacyclovir online return – valtrex online day valtrex tournament
claritin gloom – loratadine whence claritin scarlet
loratadine quiet – loratadine last loratadine table
dapoxetine entertain – dapoxetine yesterday priligy ill
promethazine type – promethazine range promethazine genuine
ascorbic acid bosom – ascorbic acid frown ascorbic acid top
florinef put – florinef remind lansoprazole unknown
biaxin start – ranitidine deserve cytotec pills endless
bisacodyl canada – cost liv52 order liv52 20mg for sale
rabeprazole online – buy aciphex 20mg sale buy generic motilium online
buy cotrimoxazole online cheap – bactrim 960mg usa tobramycin order
purchase hydroquinone without prescription – desogestrel 0.075 mg over the counter dydrogesterone 10mg for sale
buy forxiga paypal – order generic doxepin 25mg buy acarbose generic
griseofulvin pill – buy dipyridamole pill gemfibrozil 300mg pills
order enalapril 5mg online – order generic enalapril xalatan for sale
dimenhydrinate 50 mg usa – prasugrel brand purchase risedronate pills
piroxicam tablet – rivastigmine 6mg usa rivastigmine order online
cheap monograph 600 mg – pletal 100mg ca order cilostazol sale
hydrea over the counter – hydrea us robaxin pill
cheap piracetam 800mg – purchase sinemet generic buy sinemet 10mg pills
disopyramide phosphate over the counter – lyrica online buy thorazine 100mg sale
divalproex 250mg ca – purchase topamax online brand topiramate 200mg
order cytoxan generic – antivert 25 mg us vastarel oral
order spironolactone 100mg generic – purchase prothiaden online buy revia 50mg without prescription
flexeril cheap – cyclobenzaprine online vasotec 5mg without prescription
zofran 4mg pill – how to buy ondansetron order ropinirole for sale
buy ascorbic acid generic – order ascorbic acid 500 mg for sale cheap compro pills
buy durex gel online – xalatan price order xalatan generic
leflunomide order – buy actonel 35mg online cheap cartidin
minoxidil canada – proscar over the counter buy finasteride 5mg online cheap
order generic tenormin – betapace 40 mg cost carvedilol over the counter
order verapamil 120mg pill – purchase tenoretic pill tenoretic online order
cheap atorlip – enalapril 10mg canada buy nebivolol pills for sale
lasuna online buy – buy generic lasuna himcolin canada
cheap gasex sale – order gasex without prescription diabecon sale
buy speman medication – order fincar pill purchase finasteride online cheap
buy noroxin without a prescription – oral flutamide cheap confido sale
finax sale – order sildenafil 200mg without prescription order alfuzosin pills
terazosin price – order priligy 60mg without prescription order priligy 30mg
buy generic trileptal 600mg – pirfenidone for sale buy levoxyl
buy duphalac sale – lactulose cost oral betahistine
purchase imusporin online cheap – buy gloperba paypal colchicine 0.5mg sale
order generic deflazacort – order generic deflazacort buy generic alphagan for sale
neurontin generic – gabapentin order online order sulfasalazine 500 mg pills
generic besifloxacin – buy besivance generic buy sildamax pill
benemid uk – order etodolac 600mg for sale order carbamazepine online
celebrex 200mg canada – buy generic indocin 50mg indomethacin 50mg pill
order mebeverine without prescription – buy cheap generic etoricoxib order cilostazol
generic voltaren 100mg – buy aspirin medication buy aspirin 75 mg generic
order pyridostigmine 60mg pills – pyridostigmine 60mg usa buy azathioprine 25mg without prescription
rumalaya order online – cheap rumalaya pills buy amitriptyline online
ozobax price – feldene online cheap feldene
buy diclofenac tablets – voveran canada cheap generic nimodipine
buy periactin 4mg online – tizanidine 2mg oral cost tizanidine
buy meloxicam online – buy toradol pills for sale order toradol 10mg generic
order omnicef 300mg pill – buy omnicef 300 mg generic order cleocin sale
artane where to buy – purchase voltaren gel online purchase emulgel
order prednisone 10mg pill – buy zovirax cheap elimite over the counter
isotretinoin 20mg usa – accutane 40mg tablet oral deltasone 20mg
buy permethrin generic – purchase benzac cream retin generic
betamethasone 20 gm without prescription – buy betamethasone 20gm online buy benoquin cream
buy generic flagyl for sale – cenforce sale cenforce online order
augmentin cost – buy cheap generic augmentin order synthroid 75mcg for sale
buy cozaar 50mg sale – cost keflex 500mg order cephalexin 500mg generic
clindamycin price – buy cleocin 150mg buy indomethacin sale
provigil for sale – meloset pills buy meloset 3mg pills
eurax cost – purchase eurax online cheap how to get aczone without a prescription
order zyban sale – buy shuddha guggulu online shuddha guggulu pills
capecitabine 500 mg canada – buy mefenamic acid for sale buy danazol online cheap
progesterone uk – order prometrium 100mg buy clomiphene online cheap
order fosamax 70mg pills – alendronate oral order provera
pill aygestin – brand norethindrone 5 mg buy yasmin pills
estradiol uk – cost letrozole 2.5 mg buy arimidex online
purchase dostinex generic – cheap alesse tablets how to buy alesse
гѓ—гѓ¬гѓ‰гѓ‹гѓійЊ 5mg еј·гЃ• – г‚ўгѓўг‚г‚·г‚·гѓЄгѓі е‰ЇдЅњз”Ё г‚ёг‚№гѓгѓћгѓѓг‚ЇгЃЇи–¬е±ЂгЃ§иІ·гЃ€г‚‹пјџ
シルデナフィル処方 – バイアグラの購入 г‚їгѓЂгѓ©гѓ•г‚Јгѓ« е‰ЇдЅњз”Ё
гѓ—гѓ¬гѓ‰гѓ‹гѓі гЃЉгЃ™гЃ™г‚Ѓ – г‚ўг‚ュテイン гЃ©гЃ“гЃ§иІ·гЃ€г‚‹ г‚ўг‚ュテイン гЃ©гЃ“гЃ§иІ·гЃ€г‚‹