PIC/S GMP Annex 11 Computerized System Revision

PIC/S GMP Annex 11 Computerized System Revisions

2022年11月17日付でPIC/Sが「Konzeptpapier zur Überarbeitung von EU-PIC/S GMP Anhang 11 (computergestützte Systeme)」と題したNews Releaseを公表した。

It also relates to the publication of a concept paper on the revision of PIC/S GMP Annex 11.
In addition, Annex 11 of EU GMP is being revised at the same time.

Reason for Revision
This revision is intended in light of the fact that the current Annex 11, published in 2011, does not provide sufficient guidance in many areas.

The concept paper outlines the rationale for the 33 revisions involved.
For example, the following matters are described

• With respect to data integrity, Annex 11 should include requirements for “data in motion” and “data at rest” (backup, archiving, and disposal).
• Consider updating the document with regulatory expectations for “digital transformation” and similar emerging concepts.
• Add reference to ICH Q9.
  (lessening the significance or value of the previous word) the likes of

The concept paper also discusses the FDA’s recent release of draft guidance on Production and Quality The concept paper also discusses the release of the recent FDA draft guidance on Computer Software Assurance (CSA) for Production and Quality Systems,
“The guidance and its implications are considered with respect to potential regulatory-related aspects of GMP Annex 11. aspects of GMP Annex 11 will be taken into account.”
The release of the guidance and its impact on the potential regulatory aspects of GMP Annex 11 will be taken into account.

Call for public comments on concept paper
Public comments on said concept paper are being solicited from November 16, 2022 to January 16, 2023.

Timeline of revisions described in the concept paper (excerpts)
December 2022: Deadline for public comments on concept paper
December 2024: Draft guidance issued, public comments invited (3 months)
March 2025: Deadline for public comments on draft guidance
June 2026: Guidance issued by the EC
September 2026: Acceptance by PIC/S

PIC/S news release↓
Concept Paper on the revision of EU-PIC/S GMP Annex 11 (Computerised Systems)
https://picscheme.org/en/newsPIC/S GMP Annex 11 Revision Concept Paper↓.
https://picscheme.org/docview/4967

related product

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

]]>