品質リスクマネジメントの要点
ICH Q9 「品質リスクマネジメントに関するガイドライン」が発出されたのは、2006年9月1日である。
つまりリスクの高い医薬品業界において、20世紀中はリスクマネジメントに関する標準やガイドラインがなかったのである。
食品業界においてはHACCP(ハセップ)と呼ばれるリスクマネジメント手法が1970年代からあった。
また医療機器業界においては 国際規格であるISO 14971が1990年代から存在した。
しばしば”クスリ”を逆に読めば”リスク”と言われる。
しかしながら、20世紀における医薬品の製造は、なんらかのガイドラインもなく人の経験と勘に頼っていたのである。
品質リスクマネジメントは、要員の経験と勘に頼るのではなく、科学的なリスクマネジメントを実施することが重要である。
品質リスクマネジメントにおいては、医薬品の「品質」における欠陥が患者に及ぼす「健康被害」を管理する。
医療機器におけるリスクマネジメントは、当該機器の故障が患者やユーザに直接影響を与えるのに対して、医薬品の製造におけるリスクは、何らかの失敗事象が医薬品の品質に結果をもたらし、欠陥を持った医薬品が患者に投薬された際に何らかの健康被害を及ぼすと言った、いわば間接的なリスクマネジメントである。
これが「リスクマネジメント」ではなく「品質リスクマネジメント」と呼ばれる所以である。
つまり、医療機器等におけるリスクマネジメントはダイレクト(直接的)であるのに対して、医薬品におけるリスクマネジメントは品質を介して患者に健康被害を与えると言った、インダイレクト(間接的)なリスクマネージメントである。
製造所における構造設備等の欠陥(故障、操作ミス等)が医薬品の品質に及ぼす影響を抽出するのである。
なお、ICH-Q9は、医薬品のライフサイクル全般(開発、製造、配送、査察及び承認申請/審査)をカバーしている。
つまり製薬企業のみならず規制当局も遵守義務があるのである。
また医薬品製造のみならず医薬品の開発もその適用範囲に含まれる。
品質リスクマネジメントは、医薬品品質システムと表裏一体をなし、ライフサイクルモデル(PDCA)を基本としなければならない。
つまり、品質リスクマネジメントは、決して医薬品品質システムの1プロセスではない。
また、品質リスクマネジメントを実施する専門部署を設置する訳ではない。
さらに、品質リスクマネジメントを実施するSOPを1冊作成する訳でもない。
規制対象のすべての既存部門のすべての既存SOPに品質リスクマネジメントの概念を入れ込まなければならないのである。
品質リスクマネジメントでは、医薬品製造における「医薬品の品質に欠陥を生じさせるリスク」を適切にマネジメント(管理)し、患者への健康被害を防止することが目的である。
例えば、
・構造設備の故障
・ヒューマンエラー
・ソフトウェアのバグ
・データインテグリティの欠陥
等である。
一方において、いたずらにコンプライアンスコストをはね上げ、結果的に患者負担を増大させないことに留意しなければならない。
リスクベースドアプローチをとること。
改正 GMP 省令においては、品質リスクマネジメント責任者を設置することとなった。(改正GMP省令 第3条の4 第2項)
構造設備における品質リスクマネジメントでは、故障、操作ミス(ヒューマンエラー)などの失敗事象に対して、主にFMEAを使用する。
設備導入時に実施すること。適格性評価(クオリフィケーション)におけるOQでFMEAを使用し、リスクコントロールを検証(リスクが十分に低減したことを確認)すること。
自動化装置(コンピュータ化システム)では、CSVを実施し品質リスクを低減すること。
関連商品
[blogcard url=”https://ecompliance.co.jp/SHOP/GMP-12.html” title=”【GMP省令対応】品質リスクマネジメント規程・手順書・様式” ]
[blogcard url=”https://ecompliance.co.jp/SHOP/EL-111.html” title=”【セミナービデオ】【医薬品】品質リスクマネジメントの具体的な実施方法セミナー 【品質リスクマネジメント手順書配布・実習付き】” ]
[blogcard url=”https://ecompliance.co.jp/SHOP/191120P.html” title=”【VOD】製薬企業における品質リスクマネジメントセミナー” ]
[blogcard url=”https://ecompliance.co.jp/SHOP/O091.html” title=”【VOD】【医薬品】品質リスクマネジメントの具体的な実施方法セミナー 【品質リスクマネジメント手順書配布・実習付き】” ]
[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS(手順書)ひな形 医薬品関連” ]
I am curious to find out what blog system you’re utilizing?
I’m experiencing some minor security issues with my
latest site and I’d like to find something more safe.
Do you have any suggestions?
Hmm it appears like your website ate my first comment (it was extremely long) so I guess I’ll just sum it up what I submitted and say, I’m thoroughly
enjoying your blog. I as well am an aspiring blog blogger but I’m still
new to everything. Do you have any suggestions for newbie blog writers?
I’d really appreciate it.
After looking over a handful of the articles on your website,
I honestly like your way of blogging. I added it to my bookmark website list and will be checking back soon. Please check out my web
site too and tell me your opinion.
Can I simply say what a relief to find a person that actually understands
what they’re talking about on the internet.
You definitely know how to bring a problem to light and make it important.
More and more people need to read this and understand this side of your story.
I was surprised that you are not more popular because you definitely possess the gift.
I think the admin of this website is genuinely working hard
in favor of his website, since here every data is quality based data.
When I originally commented I clicked the “Notify me when new comments are added” checkbox and now each
time a comment is added I get three emails with the same comment.
Is there any way you can remove people from that service?
Cheers!
I think this is among the most vital information for me.
And i’m glad reading your article. But want to remark on some general things,
The web site style is perfect, the articles is really great :
D. Good job, cheers
Hello, Neat post. There is a problem with your web site in internet explorer, may test this?
IE nonetheless is the market leader and a large element of people will pass over your fantastic writing because of this problem.
I have been surfing online more than 2 hours today, yet I never found
any interesting article like yours. It’s pretty worth enough for
me. In my opinion, if all web owners and bloggers made good content as you did, the web
will be much more useful than ever before.
Great article.
I used to be recommended this blog via my cousin. I am now not positive
whether or not this submit is written by means of him as nobody else recognise such distinctive approximately my
trouble. You are amazing! Thank you!
If you are going for best contents like I do, just pay
a quick visit this site all the time because it offers feature contents, thanks
I like the helpful information you provide in your articles.
I’ll bookmark your weblog and check again here regularly.
I’m quite sure I’ll learn lots of new stuff right here!
Good luck for the next!
These are really wonderful ideas in on the topic of blogging.
You have touched some pleasant factors here.
Any way keep up wrinting.
Hello, i think that i saw you visited my website so i came to
“return the favor”.I’m trying to find things to improve my website!I suppose its ok to use a few of your ideas!!
Hi there! Would you mind if I share your blog with my myspace group?
There’s a lot of people that I think would really appreciate your content.
Please let me know. Many thanks
Hey outstanding blog! Does running a blog like this take
a lot of work? I’ve no knowledge of coding however I had been hoping to start my own blog soon.
Anyway, should you have any ideas or tips for new blog owners please share.
I understand this is off topic but I simply wanted to
ask. Kudos!
It’s going to be finish of mine day, but before ending I am reading this fantastic paragraph to increase my experience.
It’s really a nice and useful piece of information. I’m glad that you shared this useful
information with us. Please stay us informed like
this. Thank you for sharing.
Hi there, everything is going nicely here and ofcourse every one
is sharing data, that’s genuinely fine, keep up writing.
I am regular reader, how are you everybody?
This article posted at this web site is actually pleasant.
This paragraph gives clear idea designed for the new users of blogging, that in fact how to do blogging and site-building.
Hi there all, here every one is sharing such familiarity, thus it’s
fastidious to read this weblog, and I used to pay a
visit this blog everyday.
We stumbled over here coming from a different web
address and thought I might check things out. I like what I see
so now i’m following you. Look forward to looking over your web page
yet again.
Usually I do not learn article on blogs, but I would like
to say that this write-up very forced me to try and do it!
Your writing style has been amazed me. Thanks, very great article.
Howdy! I could have sworn I’ve been to this website before but after reading through some of the post I realized it’s new to me.
Nonetheless, I’m definitely glad I found it and
I’ll be bookmarking and checking back often!
Hurrah, that’s what I was seeking for, what a data!
present here at this website, thanks admin of this website.
Admiring the commitment you put into your site and detailed information you offer.
It’s good to come across a blog every once in a while that isn’t the same old rehashed information. Excellent read!
I’ve saved your site and I’m including your RSS feeds to my Google account.
I’m not sure why but this site is loading very slow for me.
Is anyone else having this issue or is it a problem on my end?
I’ll check back later on and see if the problem still
exists.
Good information. Lucky me I recently found your website by
accident (stumbleupon). I’ve saved as a favorite for later!
My partner and I stumbled over here by a different page and thought I might check things out.
I like what I see so i am just following you.
Look forward to exploring your web page again.
Aw, this was a really good post. Taking a few minutes and actual effort to create a very good article… but what can I say… I
put things off a whole lot and never manage to get nearly anything done.
Paragraph writing is also a excitement, if
you be acquainted with afterward you can write if not it is difficult to write.
Does your website have a contact page? I’m having trouble locating it but, I’d like to send you an e-mail.
I’ve got some recommendations for your blog you might be interested
in hearing. Either way, great site and I look forward to seeing it expand over time.
Hi, its pleasant post about media print, we all know media
is a impressive source of facts.
This is my first time visit at here and i am in fact impressed to read everthing at one place.
Hi, i believe that i noticed you visited my web site thus
i came to return the choose?.I’m trying to find things to improve my site!I assume
its adequate to make use of some of your ideas!!
Currently it looks like WordPress is the top blogging platform available right now.
(from what I’ve read) Is that what you’re using on your blog?
Hello! This post could not be written any better!
Reading this post reminds me of my old room
mate! He always kept talking about this. I will forward this write-up to him.
Fairly certain he will have a good read.
Many thanks for sharing!
When some one searches for his vital thing, therefore he/she desires to be
available that in detail, so that thing is maintained over here.
I think the admin of this website is truly working hard in support
of his web site, as here every information is quality based stuff.
Thanks for ones marvelous posting! I truly enjoyed reading it, you
happen to be a great author.I will be sure to bookmark
your blog and will come back later on. I want to encourage continue your great posts, have a nice weekend!
With havin so much content and articles do you ever run into
any problems of plagorism or copyright infringement? My site has a lot of exclusive content
I’ve either written myself or outsourced but it appears a lot of it is popping
it up all over the web without my agreement. Do you know any solutions to help reduce content
from being stolen? I’d genuinely appreciate it.
Pretty part of content. I simply stumbled upon your web site and in accession capital to say
that I acquire in fact enjoyed account your blog posts.
Anyway I’ll be subscribing to your augment and even I success you get admission to constantly fast.
It’s an awesome post for all the online visitors; they will take benefit from it I am sure.
Good write-up. I certainly love this site. Thanks!
Hi my loved one! I want to say that this post is amazing, great written and come with approximately all
vital infos. I would like to peer more posts like this
.
Nice blog right here! Additionally your web site lots up very fast!
What web host are you using? Can I am getting your associate hyperlink to your host?
I wish my website loaded up as fast as yours lol
It is in point of fact a great and useful piece of information. I¦m happy that you just shared this helpful info with us. Please stay us up to date like this. Thanks for sharing.
Super-Duper site! I am loving it!! Will come back again. I am bookmarking your feeds also.
Just a smiling visitor here to share the love (:, btw great layout. “Reading well is one of the great pleasures that solitude can afford you.” by Harold Bloom.
This is a very good tips especially to those new to blogosphere, brief and accurate information… Thanks for sharing this one. A must read article.
I would like to thnkx for the efforts you have put in writing this blog. I am hoping the same high-grade blog post from you in the upcoming as well. In fact your creative writing abilities has inspired me to get my own blog now. Really the blogging is spreading its wings quickly. Your write up is a good example of it.
Thank you for sharing excellent informations. Your site is so cool. I am impressed by the details that you¦ve on this web site. It reveals how nicely you perceive this subject. Bookmarked this web page, will come back for more articles. You, my pal, ROCK! I found simply the info I already searched everywhere and simply couldn’t come across. What an ideal web-site.
I think other site proprietors should take this web site as an model, very clean and wonderful user genial style and design, as well as the content. You are an expert in this topic!
An fascinating discussion is price comment. I feel that it is best to write more on this matter, it may not be a taboo subject however typically persons are not sufficient to speak on such topics. To the next. Cheers
Lottery Defeater Software? Lottery Defeater is a software application created to help people win lotteries
Perfectly composed content material, Really enjoyed studying.
Once I originally commented I clicked the -Notify me when new comments are added- checkbox and now each time a remark is added I get 4 emails with the identical comment. Is there any way you possibly can remove me from that service? Thanks!
Hiya, I am really glad I’ve found this info. Today bloggers publish only about gossips and internet and this is really annoying. A good website with exciting content, this is what I need. Thank you for keeping this website, I will be visiting it. Do you do newsletters? Can not find it.
This is really interesting, You are a very skilled blogger. I have joined your rss feed and look forward to seeking more of your fantastic post. Also, I’ve shared your site in my social networks!
I cling on to listening to the reports talk about getting free online grant applications so I have been looking around for the most excellent site to get one. Could you advise me please, where could i get some?
I am usually to running a blog and i actually appreciate your content. The article has actually peaks my interest. I am going to bookmark your site and preserve checking for new information.
Renew is a nutritional supplement that activates your metabolism and promotes healthy sleep.
Dead composed content, thankyou for selective information.
Puravive is a natural weight loss supplement and is said to be quite effective in supporting healthy weight loss.
I really appreciate this post. I have been looking all over for this! Thank goodness I found it on Bing. You have made my day! Thanks again
I would like to thnkx for the efforts you’ve put in writing this blog. I am hoping the same high-grade site post from you in the upcoming as well. Actually your creative writing abilities has inspired me to get my own blog now. Really the blogging is spreading its wings rapidly. Your write up is a good example of it.
Ikaria Lean Belly Juice is a dietary supplement that helps in losing weight.
I went over this site and I conceive you have a lot of great information, saved to my bookmarks (:.
Nice read, I just passed this onto a friend who was doing a little research on that. And he actually bought me lunch because I found it for him smile So let me rephrase that: Thank you for lunch! “There are places and moments in which one is so completely alone that one sees the world entire.” by Jules Renard.
What is Gluco6 Supplement? Gluco6 is a blend of doctor-formulated ingredients promising to help users develop healthy blood sugar ranges.
But wanna admit that this is very useful, Thanks for taking your time to write this.
I have been exploring for a little bit for any high-quality articles or weblog posts in this kind of house . Exploring in Yahoo I finally stumbled upon this site. Studying this information So i am glad to express that I’ve a very just right uncanny feeling I discovered just what I needed. I so much certainly will make sure to don’t overlook this website and give it a glance regularly.
What Is Java Burn? Java Burn is an herbal weight loss formula that comes in the form of sachets of fine powder.
Lottery Defeater: What Is It? A software tool called Lottery Defeater was created to raise the odds of winning lottery tickets.
I am glad to be a visitor of this utter website! , thanks for this rare information! .
I want foregathering useful info, this post has got me even more info! .
Hi , I do believe this is an excellent blog. I stumbled upon it on Yahoo , i will come back once again. Money and freedom is the best way to change, may you be rich and help other people.
I was wondering if you ever thought of changing the layout of your blog? Its very well written; I love what youve got to say. But maybe you could a little more in the way of content so people could connect with it better. Youve got an awful lot of text for only having 1 or two pictures. Maybe you could space it out better?
Its like you read my thoughts! You seem to understand so much approximately this, like you wrote the e book in it or something. I think that you could do with a few to pressure the message house a bit, however other than that, this is magnificent blog. An excellent read. I’ll certainly be back.
What Is FitSpresso? FitSpresso is a dietary supplement that is made to support healthy fat-burning in the body
Pretty! This was a really wonderful post. Thank you for your provided information.
Hey, you used to write fantastic, but the last few posts have been kinda boring… I miss your super writings. Past several posts are just a bit out of track! come on!
Greetings! I know this is kinda off topic but I was wondering which blog platform are you using for this site? I’m getting tired of WordPress because I’ve had issues with hackers and I’m looking at options for another platform. I would be great if you could point me in the direction of a good platform.
you’ve gotten an ideal blog here! would you like to make some invite posts on my blog?
I have been absent for some time, but now I remember why I used to love this web site. Thanks, I’ll try and check back more often. How frequently you update your site?
Good ?V I should definitely pronounce, impressed with your website. I had no trouble navigating through all the tabs and related info ended up being truly simple to do to access. I recently found what I hoped for before you know it in the least. Reasonably unusual. Is likely to appreciate it for those who add forums or anything, web site theme . a tones way for your customer to communicate. Nice task..
You really make it appear really easy together with your presentation however I to find this matter to be really one thing that I think I would by no means understand. It kind of feels too complicated and extremely huge for me. I am having a look ahead on your next put up, I?¦ll attempt to get the hold of it!
I like this post, enjoyed this one appreciate it for putting up. “Abortion is advocated only by persons who have themselves been born.” by Ronald Reagan.
Greetings from Idaho! I’m bored to tears at work so I decided to check out your site on my iphone during lunch break. I enjoy the info you present here and can’t wait to take a look when I get home. I’m amazed at how quick your blog loaded on my cell phone .. I’m not even using WIFI, just 3G .. Anyhow, very good blog!
As a Newbie, I am continuously exploring online for articles that can aid me. Thank you
I gotta favorite this web site it seems very beneficial invaluable
I really like your writing style, great info, regards for posting :D. “Inquiry is fatal to certainty.” by Will Durant.
It’s hard to find knowledgeable people on this topic, but you sound like you know what you’re talking about! Thanks
What Is Neotonics? Neotonics is a skin and gut supplement made of 500 million units of probiotics and 9 potent natural ingredients to support optimal gut function and provide healthy skin.
What Is LeanBiome?LeanBiome is a natural weight loss supplement that reverses bacterial imbalance in your gut microbiome with the help of nine science-backed lean bacteria species with Greenselect Phytosome, a caffeine-free green tea extract crafted with patented
Howdy I am so glad I found your webpage, I really found you by mistake, while I was browsing on Askjeeve for something else, Anyways I am here now and would just like to say cheers for a tremendous post and a all round thrilling blog (I also love the theme/design), I don’t have time to read through it all at the moment but I have saved it and also included your RSS feeds, so when I have time I will be back to read a lot more, Please do keep up the excellent work.
I?¦m now not positive the place you are getting your info, but great topic. I needs to spend some time studying much more or figuring out more. Thank you for magnificent info I was looking for this information for my mission.
I in addition to my buddies have already been viewing the best guides located on the website then instantly developed a horrible feeling I never expressed respect to the web blog owner for those secrets. All the ladies are actually as a consequence warmed to read them and have now in truth been taking advantage of these things. Thanks for indeed being quite accommodating and for obtaining this form of brilliant ideas most people are really desperate to know about. Our sincere regret for not saying thanks to you sooner.
Thanks a lot for providing individuals with an extremely superb possiblity to read in detail from this website. It is often so pleasant and as well , packed with a lot of fun for me and my office acquaintances to search your web site no less than thrice in 7 days to study the new things you have got. Of course, we’re at all times fulfilled with your outstanding strategies you give. Certain 3 ideas in this article are in reality the most suitable we have ever had.
naturally like your web-site but you need to check the spelling on several of your posts. Many of them are rife with spelling problems and I find it very bothersome to tell the truth nevertheless I will surely come back again.
good post.Ne’er knew this, appreciate it for letting me know.
Wohh just what I was looking for, thanks for posting.
Wow! This blog looks exactly like my old one! It’s on a totally different topic but it has pretty much the same page layout and design. Wonderful choice of colors!
Great amazing issues here. I?¦m very glad to peer your post. Thanks a lot and i’m looking ahead to touch you. Will you please drop me a e-mail?
This really answered my downside, thank you!
I’d should test with you here. Which isn’t something I normally do! I get pleasure from studying a put up that may make folks think. Additionally, thanks for allowing me to comment!
Great – I should definitely pronounce, impressed with your web site. I had no trouble navigating through all tabs as well as related info ended up being truly simple to do to access. I recently found what I hoped for before you know it at all. Reasonably unusual. Is likely to appreciate it for those who add forums or something, site theme . a tones way for your client to communicate. Excellent task.
I dugg some of you post as I cerebrated they were very useful very helpful
There may be noticeably a bundle to learn about this. I assume you made certain good factors in options also.
Sight Care review
Fitspresso reviews
Cellucare reviews
Cellu care
Lottery defeater software
Sight Care
Fitspresso
Lottery defeater system reviews
Sight Care reviews
Sight Care
Nano defense
Fit spresso stands as a scientifically validated weight loss formula intricately crafted from potent ingredients, aimed at enhancing the body’s metabolic functions. Tailored to support the circadian rhythm and ignite the fat-burning process, this supplement is conveniently available in edible pill form for daily consumption.
Fitspresso review
Lottery defeater system reviews
Cellucare reviews
Cellucare review
Lottery defeater system
Fitspresso reviews
Lottery defeater software
Lottery defeater
Opinipix funciona
Opini pix
Ikaria Lean Belly Juice review
Cellu care reviews
Fitspresso review
Fitspresso
Fitspresso reviews
Fitspresso reviews
Dentavim review
Fitspresso reviews
Fitspresso reviews
Fitspresso is a brand-new natural weight loss aid designed to work on the root cause of excess and unexplained weight gain. The supplement uses an advanced blend of vitamins, minerals, and antioxidants to support healthy weight loss by targeting the fat cells’ circadian rhythm
Fitspresso
Fitspresso review
Fitspresso review
Fitspresso
Fitspresso review
DENTAVIM
Fitspresso
Fitspresso review
Zencortex reviews
Lottery defeater software reviews
Neotonics review
Sight care review
Sight care review
Dentavim review
PROVADENT OFFICIAL
DENTAVIM
Dentavim is a dietary supplement formulated to support oral health and improve dental hygiene. With increasing awareness of the importance of maintaining good oral health, Dentavim has emerged as a popular choice for individuals seeking to enhance their dental care regimen. This article provides a detailed overview of Dentavim, including its ingredients, benefits, potential side effects, and overall effectiveness.
TONIC GREENS REVIEWS
LOTTERY DEFEATER SOFTWARE
I like what you guys are up too. Such smart work and reporting! Carry on the superb works guys I have incorporated you guys to my blogroll. I think it will improve the value of my website 🙂
Lottery defeater software reviews
Lottery defeater system reviews
Magnificent website. Lots of helpful information here. I am sending it to some pals ans additionally sharing in delicious. And of course, thanks in your sweat!
Sightcare reviews
Neotonics gummies
Fitspresso review