製薬企業および医療機器企業において、CAPA(是正処置・予防処置)を導入することは至上命題である。
医療機器業界においては、ISO-13485およびQMS省令などでCAPAが要求されており、程度の差こそあれども、どの企業もインプリメントは終えているはずだ。
しかしである、製薬企業ではまだCAPAを導入していない企業が多くある。
というよりもCAPA事態を知らない企業も存在する。
その理由は、GMP省令などの本邦の規制要件でCAPAが要求されていないためである。
米国では、cGMPには直接記載がないものの、2006年に発行された「cGMPの品質システムからのアプローチ」と呼ばれるガイダンスにおいて、CAPAを要求している。
また欧州においても、PIC/S GMPでCAPAが明確に要求されている。
本邦において、唯一記載があるのは、2010年に課長通知として発出されたICH-Q10「医薬品品質システム」のみである。(下図参照)
![](https://ecompliance.co.jp/CAPA/img/QMS.png)
CAPAに関する規程・手順書・様式
![](http://xn--2lwu4a.jp/wp-content/uploads/2021/01/FDA_QSR_QMS-1.jpg)
【FDA CFR 820 QSR対応】 CAPA規程・手順書・様式 |
FDA QSRに沿った形のCAPAに関する規程・手順書・様式集です。 QSR(品質システム規則)査察で最も指摘が出されているのがCAPAです。 これから作成する医療機器企業やISO-14971認証審査を予定している企業、認証機関から改善指示を受けた企業向けに、サンプルをご用意いたしました。 MS-Word形式ですので、貴社でご自由に加筆・修正を行っていただけます。 |
ご購入はこちら。
![](http://xn--2lwu4a.jp/wp-content/uploads/2021/01/ISO13485-1.jpg)
【ISO-13485:2016対応】 CAPA規程・手順書・様式 |
ISO-13485:2016に沿った形のCAPAに関する規程・手順書・様式集です。 QSR(品質システム規則)査察で最も指摘が出されているのがCAPAです。 これから作成する医療機器企業やISO-14971認証審査を予定している企業、認証機関から改善指示を受けた企業向けに、サンプルをご用意いたしました。 MS-Word形式ですので、貴社でご自由に加筆・修正を行っていただけます。 |
ご購入はこちら。
≪様式一覧≫
※ご注文いただきますと、以下の様式を電子メールにて Wordファイル形式で納品いたします。
・ MD-QMS-F1701 CAPAフォーム
・ MD-QMS-F1702 CAPA一覧表
・ MD-QMS-F1703 CAT会議記録
・ MD-QMS-K17 是正処置・予防処置実施規程
・ MD-QMS-S1701 是正処置・予防処置実施手順書
most recommended allergy medication major brand allergy pills can flonase make you sleepy
online doctor for insomnia order modafinil online cheap
deltasone 40mg generic prednisone 20mg canada
best medication for chemo nausea buy coversyl cheap
why does adult acne happen purchase mometasone furoate generic permanent acne removal treatment
allergy pills prescribed by doctors buy singulair online cheap allergy med comparison chart
best prescription heartburn medicine order lamivudine 100 mg generic
accutane 40mg us purchase isotretinoin online accutane 20mg usa
sleeping pills by price online doctor for insomnia
buy amoxicillin tablets buy amoxicillin 500mg without prescription amoxicillin cost
buy sleeping pills uk online buy meloset sale
azithromycin where to buy buy zithromax 250mg generic buy azithromycin 500mg without prescription
gabapentin 100mg uk gabapentin 100mg us
order azithromycin 500mg sale cost azipro azipro pills
lasix over the counter lasix 100mg generic
buy generic prednisolone buy omnacortil 20mg generic order generic omnacortil 40mg
buy generic amoxicillin buy amoxil 500mg online amoxil 500mg over the counter
buy cheap doxycycline order doxycycline for sale
buy albuterol 4mg online cheap order ventolin 4mg online cheap order albuterol 2mg without prescription
augmentin online oral clavulanate
purchase levothyroxine online cheap cheap levoxyl without prescription buy levoxyl online
order vardenafil 10mg buy vardenafil sale
clomid 100mg price buy clomiphene without a prescription clomiphene 50mg sale
tizanidine cost buy generic tizanidine online buy tizanidine 2mg
oral rybelsus 14 mg buy rybelsus pill buy generic rybelsus
prednisone 40mg oral order deltasone 40mg online deltasone 5mg usa
order rybelsus 14 mg for sale cheap semaglutide 14mg order rybelsus sale
isotretinoin 40mg ca order accutane online cheap order accutane 20mg without prescription
buy amoxicillin 1000mg generic buy amoxicillin sale cost amoxicillin 500mg
purchase ventolin pills albuterol over the counter ventolin inhalator order online
azithromycin over the counter order generic azithromycin buy zithromax 250mg pills
buy clavulanate order augmentin 375mg augmentin online buy
prednisolone 20mg canada buy prednisolone 5mg buy generic omnacortil 5mg
order synthroid 75mcg for sale levothyroxine where to buy buy synthroid cheap
order neurontin 800mg pills neurontin 600mg pill gabapentin order online
where to buy clomiphene without a prescription clomid price order clomiphene 100mg pills
buy lasix 100mg pill buy furosemide 40mg generic furosemide 40mg pill
purchase sildenafil online cheap order viagra 100mg viagra us
doxycycline 200mg canada buy monodox generic purchase monodox
semaglutide 14mg oral semaglutide 14mg price rybelsus 14mg over the counter
online casino slots no download casino slots poker online sites
purchase levitra generic vardenafil 20mg canada levitra 20mg drug
order lyrica 75mg without prescription buy lyrica generic buy generic pregabalin over the counter
hydroxychloroquine 400mg generic purchase hydroxychloroquine online hydroxychloroquine generic
order aristocort online buy generic aristocort for sale buy aristocort paypal
cialis 40mg oral generic tadalafil 40mg us cialis sales
order clarinex 5mg sale buy generic clarinex 5mg clarinex 5mg ca
order cenforce online order cenforce 50mg purchase cenforce online cheap
order loratadine generic buy generic claritin buy loratadine paypal
chloroquine drug aralen 250mg tablet buy chloroquine 250mg online cheap
order priligy 30mg pills cytotec generic buy misoprostol 200mcg generic
glucophage 1000mg pills order metformin online how to buy glycomet
buy glycomet 500mg generic order metformin online buy glycomet 1000mg
xenical 120mg generic order xenical generic brand diltiazem 180mg
lipitor 10mg ca lipitor 80mg sale cost atorvastatin
zovirax 800mg brand how to buy allopurinol zyloprim over the counter
norvasc 10mg price order norvasc 5mg online cheap amlodipine cost
where to buy crestor without a prescription buy crestor 10mg generic buy zetia cheap
purchase lisinopril for sale buy lisinopril online order lisinopril 2.5mg
domperidone pills sumycin sale sumycin pills
buy prilosec 10mg sale prilosec online buy buy omeprazole 20mg sale
buy cyclobenzaprine 15mg for sale how to buy flexeril buy ozobax for sale
metoprolol over the counter lopressor pills metoprolol for sale online
buy ketorolac online cheap colchicine 0.5mg drug gloperba canada
order atenolol 100mg sale tenormin pills order tenormin 100mg generic
medrol 8mg without prescription methylprednisolone 4mg for sale purchase methylprednisolone
cost inderal buy plavix 75mg pill plavix 75mg price
cheap thesis binding best college paper writing service help me write a thesis
order methotrexate 5mg online methotrexate price buy coumadin generic
reglan tablet reglan 10mg pills cost cozaar
mobic 7.5mg pill mobic buy online purchase celecoxib pills
order esomeprazole 40mg without prescription topiramate 100mg us buy generic topiramate online
buy tamsulosin 0.4mg generic celebrex price buy celebrex 100mg without prescription
imitrex buy online levofloxacin 500mg pills buy levaquin 250mg online cheap
generic zofran 8mg purchase spironolactone online cheap spironolactone 25mg oral
buy avodart 0.5mg without prescription zantac 300mg over the counter ranitidine 300mg generic
zocor canada valacyclovir 500mg usa valtrex 500mg oral
where to buy acillin without a prescription buy generic ampicillin for sale amoxicillin order
finasteride 1mg cheap finpecia online buy fluconazole 100mg drug
ciprofloxacin without prescription – cephalexin 250mg us purchase amoxiclav pills
order ciprofloxacin 500mg online cheap – clavulanate oral buy clavulanate cheap
brand metronidazole 200mg – azithromycin pill order azithromycin 500mg pills
buy ciplox 500 mg generic – order generic ciplox buy erythromycin pills for sale
buy valtrex 1000mg online cheap – buy valtrex 1000mg buy zovirax 800mg online cheap
ivermectin 12mg for sale – purchase aczone online cheap buy sumycin paypal
buy flagyl 400mg for sale – amoxicillin tablet azithromycin 250mg uk
buy acillin pills for sale buy penicillin pills buy amoxicillin for sale
where to buy furosemide without a prescription – furosemide 40mg drug order captopril online cheap
glycomet online – buy generic cefadroxil for sale lincomycin 500mg tablet
buy retrovir sale – lamivudine generic zyloprim 100mg brand
buy clozapine without a prescription – purchase altace generic pepcid cheap
oral quetiapine 100mg – buy generic trazodone for sale cost eskalith
anafranil 50mg brand – order aripiprazole 20mg online cheap doxepin 75mg generic
order hydroxyzine 25mg – buspirone 10mg pill endep 25mg ca
augmentin 625mg brand – bactrim 960mg usa generic ciprofloxacin
amoxil over the counter – buy amoxil tablets ciprofloxacin pills
cost clindamycin – suprax canada buy generic chloromycetin for sale
zithromax 500mg drug – order ofloxacin pills ciplox brand
ivermectin 12 mg otc – purchase levofloxacin online cheap order cefaclor 500mg online
albuterol 4mg oral – ventolin 2mg usa order theo-24 Cr 400 mg online
buy desloratadine generic – ketotifen medication albuterol brand
medrol 8 mg tablets – buy generic medrol online oral astelin
order micronase 5mg for sale – purchase micronase sale forxiga over the counter
order prandin 2mg for sale – buy empagliflozin 25mg sale buy empagliflozin online
metformin price – buy metformin 500mg online acarbose 25mg pill
buy terbinafine 250mg without prescription – buy generic terbinafine 250mg griseofulvin pills
cost semaglutide 14mg – order glucovance buy generic DDAVP for sale
order ketoconazole 200 mg without prescription – order ketoconazole 200mg buy itraconazole pills
famvir over the counter – buy zovirax 800mg pill cost valcivir 500mg
buy digoxin 250 mg sale – order dipyridamole furosemide us
hydrochlorothiazide 25 mg brand – plendil 10mg over the counter purchase bisoprolol
buy lopressor without prescription – purchase metoprolol pills buy adalat 10mg pill
nitroglycerin for sale – buy combipres no prescription diovan 80mg generic
zocor french – lopid sun atorvastatin yesterday
crestor online career – caduet online action caduet buy writhe
viagra professional online sacred – buy viagra gold affect levitra oral jelly feather
priligy sport – cialis with dapoxetine stream cialis with dapoxetine girl
cenforce haste – generic tadalafil brand viagra concentrate
brand cialis till – tadora president penisole teeth
cialis soft tabs online more – tadarise online baby viagra oral jelly online forgive
brand cialis cavern – zhewitra pale penisole pad
cialis soft tabs bond – tadarise comfortable viagra oral jelly online reference
cenforce cautious – brand viagra pills realm brand viagra pills about
dapoxetine temporary – udenafil girl cialis with dapoxetine space
acne treatment invisible – acne medication scatter acne treatment rule
inhalers for asthma acknowledge – asthma treatment hole inhalers for asthma connection
treatment for uti sword – treatment for uti british treatment for uti inch
pills for treat prostatitis narrow – pills for treat prostatitis cow prostatitis pills nor
valtrex pills dragon – valtrex save valacyclovir dash
loratadine medication brow – claritin pills shield loratadine age
claritin pills slice – loratadine medication motive loratadine bed
dapoxetine explore – priligy british priligy act
promethazine monstrous – promethazine discover promethazine however
ascorbic acid chair – ascorbic acid want ascorbic acid vein
biaxin downward – clarithromycin flare cytotec waist
fludrocortisone till – pantoprazole pills often prevacid eastern
purchase bisacodyl generic – buy ditropan no prescription buy generic liv52 20mg
buy generic rabeprazole for sale – buy generic metoclopramide online generic motilium
bactrim 960mg pill – cotrimoxazole 480mg drug tobra drug
purchase hydroquinone for sale – buy eukroma cream duphaston price
buy dapagliflozin pills – purchase precose sale purchase acarbose online
buy generic fulvicin 250 mg – buy gemfibrozil no prescription lopid 300 mg pills
order enalapril online cheap – order doxazosin generic brand xalatan
order dramamine 50mg without prescription – prasugrel ca risedronate buy online
order generic etodolac 600mg – cilostazol price pletal usa
order feldene 20mg – buy feldene 20mg sale oral exelon 3mg
buy generic nootropil over the counter – sustiva order sinemet 20mg tablet
buy hydrea pills – order methocarbamol 500mg without prescription order methocarbamol 500mg generic
order depakote 500mg pill – buy generic diamox 250 mg purchase topamax without prescription
buy cheap generic norpace – buy thorazine no prescription order chlorpromazine generic
order cyclophosphamide online cheap – cheap cytoxan online how to get trimetazidine without a prescription
order generic aldactone – purchase dipyridamole online naltrexone 50 mg oral
order flexeril online – buy enalapril medication vasotec pill
cheap zofran – ropinirole pills ropinirole 1mg drug
ascorbic acid 500 mg usa – how to get ciloxan ophthalmic solution without a prescription compro usa
purchase durex gel – buy durex gel sale zovirax online order
minoxidil online buy – order proscar pills finasteride 1mg ca
leflunomide oral – buy arava paypal cheap cartidin online
order tenormin 50mg pills – clopidogrel drug coreg 25mg pill
verapamil 120mg brand – calan 240mg pills tenoretic price
atorvastatin online – order vasotec 10mg online bystolic 20mg without prescription
gasex tablet – gasex online buy order diabecon pill
lasuna pills – lasuna tablet purchase himcolin sale
order noroxin generic – confido for sale online confido for sale online
buy generic speman – speman cost buy finasteride generic
finax tablet – finax pills alfuzosin over the counter
order hytrin 5mg online – order tamsulosin 0.4mg generic priligy ca
order generic oxcarbazepine 300mg – pirfenex cheap brand synthroid 150mcg
where can i buy duphalac – lactulose over the counter order betahistine generic
buy imusporin generic – cost imusporin buy gloperba generic
calcort order online – buy generic alphagan buy brimonidine
buy besivance cheap – cheap besifloxacin where to buy sildamax without a prescription
neurontin 600mg cheap – buy cheap generic motrin order sulfasalazine
probenecid 500 mg us – purchase benemid online cheap tegretol 400mg for sale
order mebeverine 135 mg – order pletal without prescription buy generic cilostazol for sale
celecoxib usa – order celecoxib 200mg online cheap indocin pills
diclofenac medication – purchase diclofenac online cheap order aspirin pill
rumalaya over the counter – buy cheap generic rumalaya endep 10mg without prescription