PIC/S GMPとEU GMPの違いとは? - 今さら聞けないPIC/S –

 PIC/S GMPとEU GMP、ほぼ内容は同じと言われますが、本当でしょうか?


まず本文のChapter 1 Pharmaceutical quality system(第1章 医薬品の品質システム)について、例をいくつか挙げます。

  1. EU GMPでは、冒頭のタイトルPharmaceutical quality systemPrinciplesの間に、この文章の成り立ちと位置付けを説明した文章が挿入されています。PIC/S GMPにはありません。

    Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
    Reasons for changes: Amendments to the text of Chapter 1 have been made in order to align with the concepts and terminology described in the ICH Q10 tripartite guideline on Pharmaceutical Quality System. The title of the chapter itself is also changed accordingly. Deadline for coming into operation: 31 January 2013 [EU GMP]

  2.  Principlesにおいて、PIC/S GMPではAuthorized Person(s)としていますが、EU GMPではQualified Person(s)と記述しています。同様の表現の違いは多数あり、この章のみならず他の章にも存在します。

    There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Authorised Person(s). [PIC/S GMP]

  3. 1.2項において、その末尾でEU GMPではICH Q10 is … of this chapterとありますが、PIC/S GMPではこの文章自体がありません。

    1.2 GMP applies to the lifecycle stages from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing through to product discontinuation. However the Pharmaceutical Quality System can extend to the pharmaceutical development lifecycle stage as described in ICH Q10, which while optional, should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. ICH Q10 is reproduced in Part III of the Guide and can be used to supplement the contents of this chapter. [EU/GMP]

  4. 1.4項の(xiv)において、PIC/S GMPではpreventiveとしているところをEU GMPではpreventativeと表記しています。

    (xiv) An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems. -中略-Appropriate corrective actions and/or preventive actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles; [PIC/s GMP]

  5. 1.9項の(vii)において、その末尾でEU GMPではin accordance with annex 16とありますが、PIC/S GMPではこの文節自体がありません。

    (vii) No batch of product is released for sale or supply prior to certification by a Qualified Person that it is in accordance with the requirements of the relevant authorisations in accordance with annex 16; [EU GMP]

  6.  1.11項において、その末尾でPIC/S GMPではThe Authorised Person … is accurateとありますが、EU GMPではこの文章自体がありません。

    1.11 The manufacturer and, where different, Marketing Authorisation holder should evaluate the results of the review and an assessment made as to whether corrective and preventive action or any revalidation should be undertaken, under the Pharmaceutical Quality System. -中略-The Authorised Person responsible for final batch certification together with the Marketing Authorisation holder should ensure that the quality review is performed in a timely manner and is accurate. [PIC/S GMP]

  7. 1.13項の(ii)において、その末尾でPIC/S GMPではin Annex 20 or ICHQ9としていますが、EU GMPではin ICH Q9 which is reproduced in Part III of the Guide.と記載されています。

    (ii) The level of effort, formality and documentation of the Quality Risk Management process is commensurate with the level of risk. Examples of the processes and applications of Quality Risk Management can be found inter alia in Annex 20 or ICHQ9. [PIC/S GMP]