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

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

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

PIC/S PI 041 – Final Version – 1. July 2021

We are pleased to announce on 1. July 2021 that the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) entered into force. The document marks the completion of significant effort by PIC/S Participating Authorities over an extended period of collaboration to address an area of significant industry and regulatory interest. The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations. The PIC/S Working Group on Data Integrity acknowledges the support from professional associations across the pharmaceutical industry who contributed to a targeted stakeholder engagement exercise in 2019. The feedback received was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.

The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis. Based on Members’ comments, it was revised by the Working Group on Data Integrity and then subject to a focused stakeholder consultation on specific issues (November 2018 – March 2019). The Working Group incorporated the feedback from stakeholders and submitted the final draft to the PIC/S Committee for adoption.

The Working Group continues its data integrity activities through development of training material for the PIC/S Inspectorates’ Academy (PIA) and other inspection-related resources for inspectors within the network.

To download this guidance (PI 041-1), please consult the page “Publications”.

Direct access to PI 041 final – 1. July 2021

New PIC/S PI041 revision issued – now DRAFT 3

On 30 November 2018 PIC/S revised the current revision of PI 041-1 – DRAFT 3.

UPDATE 2021 – PIC/S PI 041 – Final Version – 1. July 2021


Here is the announcement from the PIC/S website (source)


Focused stakeholders consultation on revised draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

Geneva, 30 November 2018: a revised Draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3)) has been prepared by the PIC/S Working Group on Data Integrity, co-led by Australia / TGA and UK / MHRA.

The purpose of the guidance is to serve to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonised approach to the inspection, including reporting in regards to data management and integrity. A first draft (PI 041-1 (Draft 2)) was published by PIC/S on a trial basis in August 2016. Following feedback received from PIC/S Participating Authorities during its 6-month implementation trial-period, the draft of this guidance has been updated and expanded by the Working Group.

The document (PI 041-1 (Draft 3)) is subject to a focused stakeholder consultation seeking substantive comments from trade and professional associations on specific questions relating to the proportionality, clarity and implementation of the guidance requirements. In parallel to this stakeholder consultation, the new draft will be applied by PIC/S Participating Authorities on a trial basis for a new implementation trial period.

The consultation period will last 3 months and run from 30 November 2018 to 28 February 2019.

To submit feedback, please provide feedback exclusively on the dedicated template available on the websites of the below associations and submit by e-mail with subject line “PIC/S Focused Public Consultation – Data Management and Integrity” to one of the following associations which will collect and compile responses. Stakeholders should only reply once.

To download the consultation document (PI 041-1 (Draft 3)) please consult the page “Publications” or click on the link below:


End of announcement.


PIC/S requests a Focused Public Consultation on Data Management and Integrity until 28. February 2019, which is highly appreciated. Please feel free to comment on the Guidance – it will be your benefit to do so.

CCS is preparing a detailed review in January 2019 in order to provide substantive comments on the current DRAFT 3 version.

Read more – Download Center


New AGIT guidelines on computerized systems (GLP)

The Swiss Working Group of Information Technology (AGIT, Arbeitsgruppe Informationstechnologie) consists of representatives of the GLP Compliance Monitoring Units and of invited experts from the industry. Several documents related to information technology in a GLP environment (status of 31.01.2018) have been developed and can be downloaded (source: admin.ch) here:

Download link (external link)

Thanks to the AGIT group for this excellent source of information and sharing it to the public in English language.

PTC Executive Exchange Event: June 28, 2018, Berlin, Germany

Industrie 4.0 – What does this mean for Medical Device and Life Sciences Innovators

Join leaders and industry experts at the 6th PTC Executive Exchange for Medical Device and Life Sciences Innovators. Together, we explore how IoT technology:

  • Increases transparency and advances efficiency to further ensure medical device quality.
  • Impacts the way medical devices are manufactured, operated, and maintained.

Read more….