[書籍] 【改正GMP省令対応シリーズ2】 改正GMP省令で要求される 『医薬品品質システム』と継続的改善

【改正GMP省令対応シリーズ2】
改正GMP省令で要求される
『医薬品品質システム』と継続的改善

～「医薬品品質システム」をICH Q10をベースにして分かりやすく解説～
付録1　改正GMP省令 対比表
付録2　改正GMP省令 逐条解説

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発刊日2021年11月26日（金）
体　裁B5判並製本 219頁
価 格 ( 税込 )44,000円
 定価：本体40,000円＋税4,000円

早割価格(発刊日まで)：38,720円
 定価：本体35,200円＋税3,520円
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ISBNコード978-4-86428-274-1
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＜【改正GMP省令対応シリーズ】今後の予定＞

　【改正GMP省令対応シリーズ１】データインテグリティ（発売中）
　【改正GMP省令対応シリーズ２】品質システム（本書籍2021/11/26発刊予定）
　【改正GMP省令対応シリーズ３】品質リスクマネジメント
　【改正GMP省令対応シリーズ４】CAPA
　【改正GMP省令対応シリーズ５】バリデーション

医薬品品質システムにおいては、
医薬品のライフサイクル全期間での継続的改善を促進しなければならない。
また、医薬品製造のための近代的な品質システムを作成し、
既存のGMPを増強する必要性がある。

書籍のポイント

改正GMP省令により、ICHやPIC/S等の国際標準のGMP基準への整合がなされた。 
それにより、特にICH-Q9（品質リスクマネジメント）や、ICH-Q10（医薬品品質システム）の遵守が求められる。 また、品質保証体制の充実が求められることとなった。

改正されたGMP省令には、おおよそ以下の要件が追加された。
1.    承認事項の遵守（第3条の2）
2.    医薬品品質システム（第3条の3）
3.    品質リスクマネジメント（第3条の4）
4.    品質保証（QA）部門の設置（第4章に追加）
5.    データインテグリティ（第8条に追加）
6.    交叉汚染の防止（第8条の2）
7.    安定性モニタリング（原薬 第21条の2、製品 第11条の2 ）
8.    製品品質の照査（第11条の3）
9.    原料等の供給者の管理（第11条の4）
10.    外部委託業者の管理（第11条の5）    
11.    原料及び資材の参考品保管（第11条に追加）
12.    製品の保存品保管（第11条に追加）
13.    製販業者への連絡・連携
14.    第11条の2 安定性モニタリング
15.    第14条 変更の管理
16.    第15条 逸脱の管理
17.    第21条の2 安定性モニタリング
（※下線は、GMP施行通知（2013/8/30）により追加した事項）

本書では、それらの中から第3条の3「医薬品品質システム」をICH Q10をベースにして分かりやすく説明する。
＜ポイント詳細＞

医薬品品質システムの要点　
＜一部抜粋＞ 
医薬品品質システム」は、読者もご存知の通り、2010年に発行されたICH Q10の考え方を日本でも導入したものである。
ICH Q10は任意のガイドラインであり、その要件は必ず遵守しなければならないということではないが、導入することが望ましいと位置付けられている。日本においては、2010年に課長通知として「医薬品品質システムガイドラインについて」（2010/2/19 薬食審査発0219第1号 薬食監麻発0219第1号）が発行された。

「医薬品品質システム」の重要な目的に、「医薬品のライフサイクル全期間での継続的改善を促進する」がある。つまり「医薬品品質システム」を構築し、常に改善を図るための仕組みを作る必要があるということである。

また、FDAが最初にGMPを立案したのは、1963年の1月のため、すでに58年が経過している。GMPは常に改訂されているとは言え、半世紀以上前に作られたものであるため、近代的な品質システムを作成し、既存のGMPを増強する必要があるということになった。
海外では、EU GMPが2013年1月に、PIC/S GMPが2017年1月に「医薬品品質システム」を導入している。

日本においては、省令の題名が「医薬品の製造および品質管理に関する基準」となっている。しかし、もはやその基準を守っていれば医薬品が安全であると主張するには無理がある。すなわち、「品質が良い」とか「安全性が担保されている」とは言えなくなっている。そこで今後は「品質保証」という概念を含めようということになり、今般の改正GMP省令に伴い導入された。


品質システムとは 
＜一部抜粋＞
「品質システム」について説明する。読者は、QCとQAという言葉はご存知だと思う。QCはQuality Controlのことである。Quality Controlとは、その品質をチェックし、品質標準からずれていた場合には、ずれを元に戻す、すなわちコントロールをすることである。

一方、QAはQuality Assuranceのことである。製造部門や試験部門等が実施した作業を第三者的に保証することをQAという。要するに、指示したまたは指導した通り実施すれば、実施者に成り代わってその品質を保証し、規制当局や顧客に説明する。また、苦情を受けた際や規制当局の査察によって指摘を受けた際に対応するというのが、Quality Assuranceである。
QA部門は、経営者から独立した権限が与えられている。具体的には、出荷判定である。QA部門が納得し、第三者的に当該部門に成り代わって品質が保証できなければ、出荷させないという独立した権限が与えられている。これがQuality Assuranceである。

このQC、QAを包含するより大きな概念がQM（Quality Management）である。これは、経営者の責任とされている。ISO9001の2000年版以前は、経営者は、経済的・金銭的な勘定のみで経営判断を行っていた。ところが、2000年以降の版によると、経営者はその金銭関係、損得関係だけではなく、品質に関しても責任を負うとされるようになった。


ICH Q10 マネジメントレビュ 
＜一部抜粋＞
マネジメントレビュは、製造プロセスの稼働性能および製品品質がライフサイクルにわたり管理されていることを保証しなければならない、すなわち「管理された状態」に置かなければならない。

また、「企業の規模及び複雑さに応じて、マネジメントレビュは種々の役職の経営陣による一連のレビュであることが可能で」とあり、経営陣によるレビュが必要とある。
PIC/S GMPにしてもICH Q10にしても上級経営陣と経営陣と記載があり、経営陣であっても、上級とそうでない人に分けていることに留意いただきたい。ここでは、「一連のレビュであることが可能で、適切な品質問題をレビュのために上級経営陣へ上げる」とあるため、一般の経営陣が上級経営陣にさらに上げるということである。「適時で有効な情報伝達および上申プロセスを含まなければならない」とあるが、ICHの規定ではわかり辛いため、改正GMP省令に基づくとどうなるかについて、後ほど具体的に紹介する。


  ICH Q10ガイドライン(医薬品品質システム)とCAPA 
＜一部抜粋＞
、、、、当然のことながら、EUのGMP、すなわちPIC/S GMPでもCAPAが要求されてきた。
ところが、日本のGMPでは、CAPAという用語が使用されたことはなかった。そのために、日本の多くの製薬企業ではCAPAの仕組みが取り入れられてこなかったのである。
ICH Q10は、日本では2010年に課長通知として発出されており、その中でCAPAの要求がされてはいたが、なかなか理解が進まず、インプリメントが進んでいなかった。それゆえ、FDA査察を受けた日本の企業の多くが、CAPAに関する指摘を受けてきたという経緯がある。ただし、「改善」という言葉はGMP省令に記載されている。改善を突き詰めるとCAPAに至るため、改善すなわちCAPAのことであるというようにご理解頂きたい。

ICH Q10（医薬品品質システム）において、その目的の一つである『継続的改善の促進』
のための必要なQMS要素の一つとしてCAPAが挙げられており、今後国内においてもその対応が必要となってくる。
CAPAは各種不適合の再発防止のためのシステムという性質上、各種QMSと比較してもその範囲は広く、システムも複雑になりがちである。適切なCAPAの運用を行う上で、その内容を関係者に周知徹底することが難しいのも実情である。


ICH Q10 変更マネジメントシステム 
＜一部抜粋＞
PQSの次の要素として、変更マネジメントシステムがある。ICH Q10では、3.2.3に変更マネジメントシステムに関する以下の規定がある。「イノベーション、継続的改善、製造プロセスの稼働性能および製品品質のモニタリングのアウトプットおよびCAPAは変更を推進する」要するに、これらの事象から変更が発生するということである。
また、「これらの変更を適切に評価し、承認し、および実施するために、企業は実効的な変更マネジメントシステムを有さなければならない」とあるため、何か問題があったときのみならず、改善を実施したい場合にも変更が生じる。各企業は、その変更を管理する手続きを記した手順書を充実させる必要がある。

また、「一般的に最初の薬事申請以前と薬事申請の変更が各極の要件下で求められることがある薬事申請後では、変更マネジメントプロセスの正式さに相違がある」ともある。ただし、製造所でGMPを担当している場合、薬事申請以前のことは関係ないため、製造所における変更とは、薬事申請以降だけが対象になる。

著者

(株)イーコンプライアンス  代表取締役 村山 浩一
【講師紹介】

～年間10件以上のFDA査察対応をこなす！FDA査察対応のスペシャリスト～

【活動】
医薬品業界・医療機器業界を担当し30年以上のキャリアをもつ。
医薬品企業・医療機器企業における、コンピュータ化システムの品質保証（CSV、Part11対応）をはじめ、リスクマネジメント、CAPA（是正処置および予防処置）、QMS構築支援、FDA査察対応等のコンサルテーションなどを幅広く展開している。
サイエンス＆テクノロジー株式会社におけるセミナー開催、著作等多数。

第1章　GMP省令の改正
はじめに
1.　改正GMP省令概要
　1.1　改正の概要
　1.2　医薬品品質システム（第3条の3）
　1.3　製造管理者の責務の見直し
　1.4　医薬部外品
2.　GMP省令の目次
3.　用語の定義
4.　手順書

第2章　医薬品品質システムの要点
1.　医薬品品質システム導入の背景
2.　ICH Q10とは
3.　医薬品品質システムとPDCA
4.　上級経営陣（製造業者等）の責任
5.　「医薬品品質システム」（PQS：Pharmaceutical Quality System）の4要素
6.　改正GMP省令とICH Q10における医薬品品質システムの違い

第3章　用語の定義

第4章　管理された状態とは
1.　ハインリッヒの法則
2.　ブロークン・ウィンドウ理論
3.　ブロークン・ウィンドウ理論の成功事例
4.　ゆでガエル現象
5.　「カイゼン」からCAPAへ
6.　自己点検
7.　教育訓練

第5章　品質システムとは
1.　QM，QA，QCの関係
2.　コンプライアンス達成のための内部統制
3.　品質システム（Quality System）とは

第6章　改正GMP省令と医薬品品質システム
1.　ICH Q10における医薬品品質システム
2.　ICH Q10における医薬品品質システムの4要素
3.　医薬品品質システム

第7章　マネジメントレビュー
1.　マネジメントレビュー（経営者による見直し）とは
2.　ICH Q10マネジメントレビュー
3.　マネジメントレビューの実施（第3条の3）
4.　マネジメントレビュー・ミーティングへのインプット（ミーティング資料の作成）

第8章　CAPA
1.　ICH Q10ガイドライン（医薬品品質システム）とCAPA
2.　CAPAとは
3.　CAPAの適用範囲

第9章　変更マネジメントシステム
1.　ICH Q10変更マネジメントシステム
2.　GMP省令第14条「変更の管理」

第10章　品質保証部門の役割と責任
1.　品質保証（QA）部門の設置
2.　品質保証部門の業務

第11章　FDA査察と品質システム
1.　FDAによるシステム査察
2.　品質システム査察とは

付録1　改正GMP省令 対比表
付録2　改正GMP省令 逐条解説
お申込みはこちら

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関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/P166_EB051a.html” title=” 【改正GMP省令対応シリーズ2】 改正GMP省令で要求される 『医薬品品質システム』と継続的改善”
content=”改正GMP省令により、ICHやPIC/S等の国際標準のGMP基準への整合がなされた。
それにより、特にICH-Q9（品質リスクマネジメント）や、ICH-Q10（医薬品品質システム）の遵守が求められる。 また、品質保証体制の充実が求められることとなった。” ]

[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS（手順書）ひな形　医薬品関連” ]

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