Concept Paper on the revision of Annex 11

The concept paper (public since 16, November 2022) addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guide. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The current version was issued in 2011 and does not give sufficient guidance within a number of areas. Since then, there has been extensive progress in the use of new technologies.


Reasons for the revision of Annex 11 include, but are not limited to the following, refer to link (external): https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products_en.pdf

Note: End of the consultation phase is 16. January 2023.

ISPE GAMP 5 – Second Edition – Training

Am 22. Mai 2023 findet von 10:00 – 13:00 Uhr ein Webinar zum Thema ″ISPE GAMP®5 – Second Edition – Enabling Innovation & CSA″ statt.

Die ISPE hat im Jahr 2008 den GAMP®5 als den anerkannten Stand von Wissenschaft und Technik bezüglich der sogenannten Computersystemvalidierung (CSV) im GXP-Umfeld global gesetzt. Der im Juli/August 2022 erschienene Band – ISPE GAMP®5 – Second Edition ist eine bewusste Erweiterung (Add-On) des bewährten GAMP®5 Standards und es sollte kein neuer GAMP 6 Standard damit entstehen.

Mit der Erweiterung in Form eines Zusatzdokuments – Second Edition – sollen diverse und wichtige Themen noch deutlicher, pragmatischer und zielführender darstellt werden. Die Validierung soll verstärkt auf Produkt-, Daten- und Prozesskenntnisse basieren und die realen Prozesse und Datenflüsse müssen noch mehr im Vordergrund des Validierungsansatzes stehen (″Critical Thinking″ Ansatz).

Ein weiterer Aspekt ist die noch intensivere Einbindung von Systemlieferanten, die oftmals agile Projektmanagement-Ansätze und agile Systementwicklungsprozesse erfolgreich anwenden. Diese Methoden lassen sich über smarte Werkzeuge und Plattformen auch für eine innovationsgetriebene Validierung (″e-Validation″) von Systemen und Prozessen adaptieren. Ebenso wird ein starker Fokus auf neu zu implementierende Systeme oder umfangreichere Innovationsprojekte (Digitalisierung, papierlose Prozesse) gelegt.

Link – BPI:

https://www.bpi.de/de/termine/detail/ispe-gampr5-second-edition-enabling-innovation-csa-1

US-FDA – CSA – Computer Software Assurance for Production and Quality System Software – Draft issued

FDA is issuing the draft guidance CSA to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.

This draft guidance is intended to:

  • Describe “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate; and
  • Describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR part 820 (Part 820). –> medical devices

When final, this guidance will supplement FDA’s guidance, “General Principles of Software Validation” (“Software Validation guidance”) except this guidance will supersede Section 6 (“Validation of Automated Process Equipment and Quality System Software”) of the Software Validation guidance.

Download the DRAFT version here: EXTERNAL LINK

Update October 2022: Online Presentation by US-FDA – CSA

Online Update Seminar: ISPE GAMP 5 – second edition – 2022

In cooperation with BPI – Bundesverband der Pharmazeutischen Industrie e.V. – the first online session in German language:

  • ISPE GAMP®5 – Second Edition
  • ISPE GAMP®5 – Enabling Innovation
  • US-FDA CSA Approach
  • EMA Annex 11 – concept paper 2022

Get an overview and quick update of GAMP 5 – 2008 vs. 2022.

In Kooperation mit dem BPI , Berlin : ISPE GAMP 5 Quick Update Seminar – online – am 27.09.2022

Die ISPE hat im Jahr 2008 den GAMP®5 als den anerkannten Stand von Wissenschaft und Technik bezüglich der sogenannten Computersystemvalidierung (CSV) im GXP Umfeld global gesetzt. Der im Juli / August 2022 erschienene Band – ISPE GAMP®5 – Second Edition ist eine bewusste Erweiterung (Add-On) des bewährten GAMP®5 Standards und es sollte kein neuer GAMP 6 Standard damit entstehen.

Mit der Erweiterung in Form eines Zusatzdokuments – Second Edition – sollen diverse und wichtige Themen noch deutlicher, pragmatischer und zielführender darstellt werden. Die Validierung soll verstärkt auf Produkt-, Daten- und Prozesskenntnisse basieren und die realen Prozesse und Datenflüsse müssen noch mehr im Vordergrund des Validierungsansatzes stehen („Critical Thinking“ Ansatz).

Ein weiterer Aspekt ist die noch intensivere Einbindung von Systemlieferanten, die oftmals agile Projektmanagement-Ansätze und agile Systementwicklungsprozesse erfolgreich anwenden. Diese Methoden lassen sich über smarte Werkzeuge und Plattformen auch für eine innovationsgetriebene Validierung („e-Validation“) von Systemen und Prozessen adaptieren. Ebenso wird ein starker Fokus auf neu zu implementierende Systeme oder umfangreichere Innovationsprojekte (Digitalisierung, papierlose Prozesse) gelegt.

Mit der Second Edition des Standardwerks zur Computersystemvalidierung ist ein hoch-innovativer Ratgeber entstanden.          

THEMENSCHWERPUNKTE

  • ISPE GAMP®5 – Second Edition – Was wurde ergänzt (Vergleich ISPE GAMP 5 – 2008)
  • ISPE GAMP®5 – Second Edition – Inhalte und Umfänge (2022)
  • ISPE GAMP®5 – Enabling Innovation (2021)
  • US –  FDA – Computer Software Assurance (CSA) – Aktueller Stand, Hintergründe und Umfänge
  • Weitere Updates und News (EMA – concept paper – GMP EudraLex Vol. 4 – Anhang 11 und Kapitel 4)

Zur Anmeldung: https://www.coll-pharm.de/Veranstaltungen/GMP/event.php?vnr=e69-110

ISPE GAMP ® 5 (Second Edition) coming soon!

Coming Soon: July 2022 

GAMP® 5 (Second Edition)

Maintaining the principles and framework of the First Edition (2008), GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of:

  • service providers;
  • evolving approaches to software development;
  • and the more widespread use of software tools and automation.

It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate qualification and validation approaches.

Read more at: https://ispe.org/publications/guidance-documents/gamp-5

OECD – Advisory Document on Good Laboratory Practice on GLP Data Integrity

OECD Environment, Health and Safety Publications Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring – No. 22 – September 2021 – released:

This advisory document was developed by the OECD Working Party on Good Laboratory Practice (GLP). The development of the document was initiated and led by the UK and included a drafting group under the leadership of Stephen Vinter (UK) and Thomas Lucotte (France Medical Products). The drafting group included representatives from Argentina, Austria (Medical Products), Belgium, Denmark (Medical Products), Italy, Mexico, the Netherlands, the US (EPA) and the US (FDA). The process included a public comment period and review and endorsement of the document by the Working Party on Good Laboratory Practice.
This document is published under the responsibility of the Chemicals and Biotechnology Committee which agreed to its declassification on 8 September 2021.

Download here

IPA Annual GMP Update 2021

About the Conference:

International Pharmaceutical Academy (IPA) is delighted to be hosting its 17th annual GMP Update | BPF Mise à jour on October 6 & 13, 2021 | Online.

This virtual conference will provide attendees with insight and a plethora of information on quality, compliance, validation, and regulatory areas affecting the pharmaceutical, biopharmaceutical and allied industries. It will address compelling issues and the current challenges of GMPs environment.

The “GMP UPDATE 2021” is the place to broaden your learning opportunities and engagement with the industry!

Attend the conference from anywhere from the comfort of your computer. This virtual event will provide participants with access to live streaming presentations, live chat and Q&A. Network with your peers on video conferencing.

Read more: https://www.accelevents.com/e/ipa-annual-gmp-update-2021

MHRA – The data lifecycle

The data lifecycle is a way of describing the different stages that data will go through, from collection to dissemination and archival/destruction. The purpose of the data and its lifecycle should be well understood by anyone who handles the data, from its collection to the eventual output.

This section of the framework describes the stages of the data lifecycle in more detail, and outlines quality issues that may occur at each stage.

Quality across the data lifecycle

Quality assessment and assurance should take place at each stage of the lifecycle. The measures used will change at each stage.

Throughout the data lifecycle, those involved should be aware of future users of the data and possible onward uses of the data, and should ensure that data quality at each stage is documented and communicated clearly.

Data practitioners may sometimes need to return to earlier stages in the lifecycle to correct data quality problems.

The stages of the data lifecycle

The data lifecycle illustrated here is not intended to be prescriptive. It is designed to illustrate the journey that data will take through most organisations and identify points at which data quality problems could happen. The actual data lifecycle for an organisation will be specific to the organisation and its processes.

Data leaders may find it helpful to use the data lifecycle here to design one for their own organisation.

Read more:

https://www.gov.uk/government/publications/the-government-data-quality-framework/the-government-data-quality-framework#The-Data-Lifecycle