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”

QP Update 2018 – Mannheim, Germany – 19./20. April 2018

Das Seminar wendet sich an alle Sachkundige Personen/ QPs. Ebenfalls angesprochen sind Leiter und Mitarbeiter von Qualitätsmanagement und Qualitätssicherung und Mitglieder der Unternehmensleitung, die einen umfassenden Überblick über Pflichten und Aufgaben der sachkundigen Personen/QPs erhalten mochten:

Qualified Person Update 2018 – Neues für die Sachkundige Person in Deutschland;   19./20. April 2018, Mannheim

Zum Online – Programm…

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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

Article: Data Integrity – FOLLOW THE DATA (@pharmind June 2017)

Data integrity has become a major challenge but also a chance for modernization and optimization. To comply with expectations and regulations, companies need to analyze their overall GMP data management, system landscape and related GMP data flows. The following article outlines a basic data-flow oriented approach for such data assessments, as well as considerations for compliant and proper data categorization, how to define different useful types of audit trails and how to define and understand the so called “Audit Trail Review” in order to gain knowledge about the product and process attributes according to ICH Q10 and Q11. (…)

READ MORE – ONLINE LINK

Aktuelle Buch Neuerscheinung: Papierbasierte und elektronische Dokumentation im Pharmaunternehmen

Auszug aus dem GMP-BERATER

Dokumentation ist ein wesentlicher Bestandteil des pharmazeutischen Qualitätssystems. Sie spielt in jeder Phase des Lebenszyklus eines Arzneimittels eine wichtige Rolle, denn die Qualität eines pharmazeutischen Produktes muss zweifelsfrei nachweisbar sein! Deshalb ist es kaum verwunderlich, dass viele Verantwortliche aus dem Pharmabereich mit einer wahren Flut an Daten und Dokumenten kämpfen müssen.

Dieses Fachbuch hilft Ihnen Schritt für Schritt, den Überblick über die Datenflut zu behalten. Neben Erläuterungen zu aktuellen regulatorischen Anforderungen finden Sie hier auch das 1×1 der guten Dokumentationspraxis im täglichen Umgang mit Dokumenten. Das Buch liefert Ihnen Informationen zu unterschiedlichen Systemtypen, GMP-relevanten Funktionen und Einsatzmöglichkeiten elektronischer Systeme. Mit diesem Wissen sind Sie gut vorbereitet für die nächste Datenflut!

Aus dem Inhalt:
  • Erstellung, Lenkung und Kontrolle von Dokumenten
  • Dokumentation im Labor
  • Anforderungen an die Datenintegrität
  • Validierung eines Dokumentenmanagementsystems
  • Umstellung auf elektronische Chargendokumentation

Mehr Informationen zum Buch: externer LINK

GXP compliant JIRA & Confluence

Partnership Announcement Radbee and CCS

CCS is delighted to announce a strategic partnership with Radbee Ltd. London, UK. RadBee Ltd. offers software solutions for quality assurance in the medtech, biotech and pharmaceutical industries. By tailoring JIRA and Confluence software to meet their clients’ specific needs, RadBee Ltd. creates quality management systems that make compliance easy and help organizations achieve more.

Continue reading “GXP compliant JIRA & Confluence”