改正QMS省令対応の要点

【連載】QMS省令改正について

【第1回】QMS省令改正

はじめに

2014年11月25日に、薬事法が一部改正され「医薬品、医療機器等の品質、有効性および安全性の確保等に関する法律」 (医薬品医療機器等法:薬機法)が施行された。
実は「薬事法等の一部を改正する法律」第66条には以下のように規定されている。

第66条 (検討)
政府は、この法律の施行後5年を目途として、この法律による改正後の規定の実施状況を勘案し、必要があると認めるときは、当該規定について検討を加え、その結果に基づいて必要な措置を講ずるものとする。

この検討条項に従い、現在、厚生労働省において以下3点をテーマに据えた「改正法の施行後5年を目途とした検討」が行なわれている。

テーマ① 革新的な医薬品・医療機器等への迅速なアクセス確保・安全対策の充実
テーマ② 医薬品・医療機器等の適切な製造・流通・販売を確保する仕組みの充実
テーマ③ 薬局・薬剤師のあり方・医薬品の安全な入手

QMS省令の改正は、テーマ①の一環であり、平成29年度 厚生労働科学研究「GMP、QMS及びGCTPのガイドラインの国際整合化に関する研究」(研究代表者:櫻井信豪氏)において改正QMS省令(案)および逐条解説(案)を検討している。
つまりGMPの改正と共にQMS省令の改正も本薬機法見直しの一環として検討がなされている。
また、上記研究においてQMS班では「電磁的な文書及び記録の管理に関するガイダンスの作成」に関する検討も実施。
品質管理監督システム(QMS)に用いられるソフトウエアにバリデーションが課されることから、医薬品GMPにおける「コンピュータ化システム適正管理ガイドライン」を参考にQMS版ガイドラインの作成手順および作成の必要性検討のためのアンケートも実施した。

改正QMS省令は当初2018年10月に施行される予定であった。しかしながら本日現在、案の公表すらされていない。

改正QMS省令の要点

改正QMS省令では、第2章部分をISO13485:2016に準拠させる。
改正のポイントは以下のとおりである。

①リスクに基づくアプローチの適用
②品質マネジメントシステムで用いるソフトウエアにバリデーションを適用
③統計学的方法に基づくサンプルサイズ

上記に加え、苦情処理・滅菌医療機器の要求事項の強化、文書化、記録作成等の要求事項の追加がなされる。
今年度中に公布・施行予定である。ただし、適用までに3年の猶予期間を設ける予定だ。

改正QMS省令において頻回登場する用語

以下の用語が改正QMS省令では頻回し登場している。

  • 文書化
  • リスク
  • 規制当局(厚生労働省等)
  • 統計学的方法
  • 要領書

特に「要領書」に注意が必要である。これまでは「手順書」の作成に重きを置いてきた。
しかしながら、通常は手順書を見ながら作業はしない。また手順を見たとしても具体的な作業方法までは記載されていない。つまり「手順書」のみでは実効性がないのである。
改正QMS省令では実効性を重んじている。
「要領書」とは具体的な作業方法が記載されてものである。
例えば、供給者に「取交し書」や「契約書」を締結するのみであったり、「手順書」を交付しても意味がなく具体的な「要領書」を交付しなければ品質の担保ができない。

改正後は、具体的な「要領書」の作成が求められる。

(次号に続く)

QMS省令は2021年3月26日に改正されました。詳しくはこちら

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/QMS-MHLW-00.html” title=”【2021年度改正QMS省令対応】QMSひな形一式” content=”すでに現行QMS省令に準拠したQMSを構築されているが改正対応が必要な企業、これから医療機器に参入する企業にオススメのひな形セットです。”]

Related post

Comment

  1. Thank you for another informative website. Where else could I get that kind of information written in such an ideal way? I have a project that I’m just now working on, and I’ve been on the look out for such info.

  2. Very interesting subject, thanks for putting up.

  3. It¦s really a nice and useful piece of info. I¦m satisfied that you just shared this helpful information with us. Please stay us up to date like this. Thanks for sharing.

  4. I truly enjoy looking through on this web site, it has wonderful articles. “And all the winds go sighing, For sweet things dying.” by Christina Georgina Rossetti.

  5. Lovely just what I was looking for.Thanks to the author for taking his time on this one.

  6. Write more, thats all I have to say. Literally, it seems as though you relied on the video to make your point. You obviously know what youre talking about, why throw away your intelligence on just posting videos to your weblog when you could be giving us something enlightening to read?

  7. Dead written subject matter, thank you for information. “In the fight between you and the world, back the world.” by Frank Zappa.

  8. Hiya, I am really glad I’ve found this information. Today bloggers publish just about gossips and internet and this is really annoying. A good site with interesting content, that is what I need. Thank you for keeping this web site, I’ll be visiting it. Do you do newsletters? Cant find it.

  9. Hey! I simply would like to give a huge thumbs up for the nice information you’ve right here on this post. I can be coming back to your weblog for more soon.

  10. It is in point of fact a nice and helpful piece of information. I am happy that you just shared this helpful info with us. Please keep us up to date like this. Thank you for sharing.

  11. I’m writing to make you be aware of what a exceptional encounter my child undergone checking your web site. She even learned a wide variety of pieces, most notably what it’s like to possess an incredible giving mindset to let certain people completely know selected advanced topics. You truly surpassed people’s expected results. Thanks for offering these warm and helpful, trusted, educational and as well as easy tips on this topic to Evelyn.

  12. I am really enjoying the theme/design of your blog. Do you ever run into any web browser compatibility issues? A handful of my blog readers have complained about my website not working correctly in Explorer but looks great in Firefox. Do you have any advice to help fix this problem?

  13. Dead composed articles, regards for entropy.

  14. DentiCore is a dental and gum health formula, made with premium natural ingredients.

  15. Java Burn: What is it? Java Burn is marketed as a natural weight loss product that can increase the speed and efficiency of a person’s natural metabolism, thereby supporting their weight loss efforts

  16. It?¦s really a cool and useful piece of information. I am satisfied that you shared this useful info with us. Please stay us informed like this. Thanks for sharing.

  17. Thanks for some other informative web site. The place else may I am getting that type of information written in such a perfect method? I have a undertaking that I am just now operating on, and I have been at the glance out for such info.

  18. LeanBiome is a probiotic dietary supplement that’s packed with lean bacteria species that help support healthy weight loss.

  19. Hello there, I found your site by means of Google even as searching for a similar matter, your site came up, it seems good. I have bookmarked it in my google bookmarks.

  20. You made certain good points there. I did a search on the subject and found most people will agree with your blog.

  21. Great post. I am facing a couple of these problems.

  22. This is the right blog for anyone who wants to find out about this topic. You realize so much its almost hard to argue with you (not that I actually would want…HaHa). You definitely put a new spin on a topic thats been written about for years. Great stuff, just great!

  23. Merely wanna state that this is very beneficial, Thanks for taking your time to write this.

  24. It’s hard to find knowledgeable people on this topic, but you sound like you know what you’re talking about! Thanks

  25. Lovely just what I was looking for.Thanks to the author for taking his time on this one.

  26. I got good info from your blog

  27. What is ProNerve 6? ProNerve 6 is a doctor-formulated nutritional supplement specifically marketed to individuals struggling with nerve pain.

  28. I am perpetually thought about this, regards for putting up.

  29. There is visibly a lot to identify about this. I suppose you made various good points in features also.

  30. Real superb information can be found on blog. “Every artist was first an amateur.” by Ralph Waldo Emerson.

  31. I have learn several excellent stuff here. Certainly worth bookmarking for revisiting. I surprise how a lot effort you set to create this sort of great informative site.

  32. Thank you for another informative web site. Where else could I get that kind of info written in such an ideal way? I’ve a project that I am just now working on, and I’ve been on the look out for such information.

  33. I am no longer certain the place you’re getting your info, however great topic. I needs to spend a while finding out much more or understanding more. Thanks for magnificent information I used to be searching for this info for my mission.

  34. Good day! I know this is kinda off topic but I was wondering if you knew where I could find a captcha
    plugin for my comment form? I’m using the same blog platform as yours and I’m having difficulty finding one?
    Thanks a lot!

  35. I was suggested this web site by means of my cousin. I am now not sure whether this submit is written by him
    as no one else know such special approximately my problem.
    You’re amazing! Thank you!

  36. FitSpresso: An Outline FitSpresso is a weight management formula made using five herbal ingredients.

  37. Terrific work! This is the kind of information that are supposed to be shared across the net.
    Disgrace on Google for now not positioning this publish higher!
    Come on over and discuss with my web site .
    Thank you =)togel4d

  38. What is Zen Cortex? ZenCortex is not just another drop in the ocean of dietary supplements

  39. I’m really loving the theme/design of your weblog. Do you ever run into any web browser compatibility issues? A couple of my blog audience have complained about my site not working correctly in Explorer but looks great in Opera. Do you have any ideas to help fix this problem?

  40. Whats Happening i’m new to this, I stumbled upon this I’ve found It absolutely useful and it has aided me out loads. I’m hoping to contribute & aid other users like its aided me. Great job.

  41. Hey there would you mind letting me know which web host you’re using? I’ve loaded your blog in 3 different browsers and I must say this blog loads a lot faster then most. Can you recommend a good hosting provider at a fair price? Cheers, I appreciate it!

  42. With havin so much content and articles do you ever run into any problems of plagorism or copyright infringement? My blog has a lot of exclusive content I’ve either written myself or outsourced but it looks like a lot of it is popping it up all over the web without my authorization. Do you know any solutions to help stop content from being ripped off? I’d genuinely appreciate it.

  43. I like this website it’s a master piece! Glad I discovered this ohttps://69v.topn google.Money from blog

  44. Hello! I just would like to give a huge thumbs up for the great info you have here on this post. I will be coming back to your blog for more soon.

  45. IWIN CLUB – Classy bookmaker dedicated to online betting enthusiasts.

    Discover now exciting perks, unique experiences and opportunities to receive attractive rewards.

    Get to know us at: [url=https://iwin.limited/lien-he/]https://iwin.limited/lien-he/[/url]

  46. Its good as your other blog posts : D, appreciate it for putting up. “A lost battle is a battle one thinks one has lost.” by Ferdinand Foch.

  47. Magnificent web site. Lots of useful information here. I am sending it to a few friends ans also sharing in delicious. And of course, thanks for your sweat!

  48. It is appropriate time to make some plans for the future and it is time to be happy. I have read this post and if I could I want to suggest you some interesting things or tips. Perhaps you could write next articles referring to this article. I wish to read more things about it!

  49. Thanks, I have recently been searching for info about this topic for a while and yours is the best I’ve discovered till now. But, what in regards to the conclusion? Are you certain concerning the source?

  50. You really make it seem so easy with your presentation but I find this matter to be really one thing that I believe I would never understand. It sort of feels too complex and extremely vast for me. I’m looking forward for your next put up, I will attempt to get the cling of it!

  51. Usually I don’t learn article on blogs, however I wish to say that this write-up very forced me to take a look at and do it! Your writing taste has been amazed me. Thanks, very nice post.

  52. wonderful post, very informative. I wonder why the other experts of this sector don’t notice this. You should continue your writing. I’m confident, you have a great readers’ base already!

  53. Hello there, I discovered your web site by way of Google whilst looking for a similar subject, your site got here up, it looks great. I have bookmarked it in my google bookmarks.

  54. Some truly choice content on this site, saved to bookmarks.

  55. Terrific post however , I was wanting to know if you could write a litte more on this topic? I’d be very grateful if you could elaborate a little bit further. Thank you!

  56. You have brought up a very wonderful points, regards for the post.

  57. Attractive part of content. I simply stumbled upon your web site and in accession capital to claim that I acquire in fact loved account your blog posts. Anyway I’ll be subscribing on your augment or even I success you access persistently rapidly.

  58. Yesterday, while I was at work, my cousin stole my iphone and tested to see if it can survive a forty foot drop, just so she can be a youtube sensation. My apple ipad is now broken and she has 83 views.

    I know this is totally off topic but I had to share it with someone!

    Also visit my blog tonic greens herpes cure

  59. Thanks for finally talking about > 改正QMS省令対応の要点
    | お役立ち情報 < Liked it!

    Feel free to surf to my homepage – boostaro in stores

  60. Hi! I know this is somewhat off topic but I was
    wondering which blog platform are you using for this site?
    I’m getting sick and 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.

    Look into my webpage; prodentim

  61. Hello there, I found your site via Google whilst
    looking for a comparable subject, your site came up, it seems to be good.
    I’ve bookmarked it in my google bookmarks.
    Hi there, just was aware of your blog thru Google, and found that it’s truly informative.
    I am going to watch out for brussels. I’ll appreciate in the event you continue this in future.

    A lot of other people shall be benefited from your writing.

    Cheers!

    Check out my page :: the brain genius wave

  62. Hello terrific website! Does running a blog similar to this
    take a great deal of work? I’ve virtually no understanding of coding
    but I was hoping to start my own blog in the near future.
    Anyways, if you have any suggestions or tips for
    new blog owners please share. I know this is off subject but I simply wanted to ask.
    Cheers!

    my page :: billionaire brain wave sound

  63. Hi there, I log on to your blogs like every week. Your writing style
    is awesome, keep up the good work!

    Here is my web page; what are the ingredients in prodentim

  64. I appreciate, result in I found just what
    I was looking for. You have ended my 4 day long hunt!
    God Bless you man. Have a great day. Bye

    Stop by my webpage – tonic greens at walmart

  65. Hey outstanding blog! Does running a blog such as this take
    a great deal of work? I’ve absolutely no knowledge of computer programming however I had been hoping to start my own blog soon. Anyhow, should you have any suggestions or techniques for new blog
    owners please share. I know this is off topic however I just needed to
    ask. Many thanks!

    my homepage: testoprim que contiene

  66. Nearly all of the things you say happens to be supprisingly appropriate and that makes me wonder the reason why I hadn’t looked at this with this light previously. Your piece really did turn the light on for me as far as this topic goes. Nevertheless at this time there is one issue I am not really too comfortable with so whilst I make an effort to reconcile that with the main idea of the point, let me observe what the rest of the subscribers have to point out.Very well done.

  67. Does your website have a contact page? I’m having trouble locating it but, I’d like to shoot you an e-mail. I’ve got some suggestions for your blog you might be interested in hearing. Either way, great website and I look forward to seeing it improve over time.

TOP