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.

MHRA’s GXP data integrity guide published – March 2018

After the British agency MHRA has published three (3) different draft versions of the – MHRA GMP Data Integrity Definitions and Guidance for Industry – in January and March 2015 (GMP) and in July 2016 (Draft for consultation – now for GXP) the final  “Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions was published in March 2018.

Looking into the history of the document and content the major changes have been to replace and extend from “GMP” to GXP (covering  GCP, GDP, GLP, GMP and GPvP).  All this GXP areas had already requirements for data integrity or study integrity or similar for many years and are covered by European EMA regulations, directives and the EMA EudraLex Volumes or other regulations (e.g. chemical for GLP). The second change was the title “Guidance for Industry” to a “Guide“. Maybe the document type “Guidance for Industry” would remind you to US regulations and you are right. But in the EU such a document type in a regulatory structure and understanding is also not known. Maybe the roots of the first versions were coming from US or consultants or authors from this region. In general an own opinion might be better as to listen to any opinion-makers with commercial interests. Continue reading “MHRA’s GXP data integrity guide published – March 2018”

Microsoft Azure GXP Guideline now published – reviewed by CCS

The goal of this GXP guidelines document is to provide life sciences organizations with a comprehensive toolset for using Microsoft Azure while adhering to industry best practices and applicable regulations. It identifies the shared responsibilities between Microsoft and its life sciences customers for meeting regulatory requirements, such as US-FDA 21 CFR Part 11 Electronic Records, Electronic Signatures (21 CFR Part 11), and EudraLex Volume 4 – Annex 11 Computerised Systems (EMA Annex 11).

Microsoft Azure GxP Guidelines – 06.12.2017 – Download

EU-US mutual recognition of inspections

1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources.

Read more:

  • EMA Press Release
  • Third QP conference: QP challenges in modern pharmaceutical trading; 29. / 30. September 2017, Belgrade

    The Conference is designed for all Qualified Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons.

    29. and 30. September 2017
    Venue Best Western Hotel M 56a Bulevar Oslobođenja Street, Belgrade

    Read more: http://www.pharmacy.bg.ac.rs/files/Doga%C4%91aji/2017/QP%20konferencija/flajer%20engleski%202017.pdf

    US-FDA: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11— Questions and Answers; Draft Guidance for Industry

    The US FDA Agency  was announcing the availability of a draft guidance for industry entitled ‘‘Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.’’ The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products.

    Download: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11— Questions and Answers; Draft Guidance for Industry