PIC/S has published on a draft basis a guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 2)) developed by the PIC/S Working Group on Data Integrity. This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities. This draft document results from the need among Inspectorates to have access to harmonised data integrity guidance, considering the impact to public health. The purpose of the trial-period is to learn from implementation. It is acknowledged that the guidance requires expanding in some areas; however, the document has value in describing foundational principles which can be enhanced in future revisions. This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures – including a stakeholders’ consultation – on a revised version after completion of the trial-period.
As part of the new set of validation guidelines, including computer systems, WHO published a set of guidelines around this subject.
The CSV draft incorporates the data integrity elements as part of the system life cycle.
Current Warning Letter:
FDA found 8,400 unofficial chromatographic analyses at the Desano plant performed between 2012 and 2014. The company has acknowledged that some of those tests related to out-of-spec test results.
The FDA was also disturbed by finding many electronic logs of production deviations in a folder titled “GMP Anomalies” that had never been investigated.
Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting. The case study provided in this white paper highlights the need for automated EM software systems to analyze large amounts of data and recognize risks before a problem occurs.
NEW: WHO Expert Committee on specifications for pharmaceutical preparations (Fiftieth report) – WHO technical report series; no. 996 (Source)
including Annex 5 – Guidance on good data and record management practices – Download- including special risk management considerations for assuring accurate GXP records
CCS releases the first beta version of “Q-Met” to provide a tool and gateway for the submission of quality metric data to the US-FDA based on data and technical specifications (draft).
Auf Einladung von BioLAGO haben Unternehmer und Hochschulvertreter bei der Fortbildungsreihe „BioLAGO academy“ IT-Lösungen zur Qualitätssicherung erörtert. Gastgeber Vetter gewährte zudem Einblicke in seine Labors. Markus Roemer, Geschäftsführer von CCS und BioLAGO-Mitglied, stellte den Teilnehmern Lösungen vor und berichtete aus der Praxis.
The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Part 210 covers 1Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography Drugs. This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements.
Download at fda,gov:
EQMS experts Mark Stevens, Operations Director and Principal Consultant from Formpipe Life Science and Markus Roemer, Consultant from comes compliance services (www.comes-services.com) will share their combined knowledge during a two part webinar series focusing on one of the industries most talked about topics of 2016 – Data Integrity.
Part 1 – June 15 2pm GMT/3pm CET/ 9am EST
Practical Introduction to Data Integrity in 30 minutes
This webinar covers what’s it all about, where to start and what is actually useful to you and your Organisation.
Formpipe will uncover practical approaches to managing Data Integrity compliance that fulfil the regulatory requirements such as 21 CFR Part 11 and Annex 11. They will provide useful insights into the impact of the recent Data Integrity guidance as well as clarify what hasn’t changed and provide practical tips to address them in a straightforward way.
Coming next: Part 2 – June 22 GMT/3pm CET/ 9am EST
Managing your Data Integrity responsibilities without creating a resource monster
Datenintegrität im Brennpunkt der Inspektionen und Audits
Die Datenintegrität der GMP-Daten ist ein zentrales Inspektionsthema. In diversen US FDA Warning Lettern als auch EMA GMP Reports werden bereits entsprechende Mängel dargestellt. Im Seminar lernen Sie die Anforderungen an die Datenintegrität kennen und Sie erfahren die aktuellen Inspektionsergebnisse.
Das brandaktuelle Dokument der FDA vom April 2016 ist in das Programm eingebaut: Data Integrity and Compliance With CGMP, Guidance for Industry, DRAFT GUIDANCE
Ihre Referenten am 29.-30.06.2016 in Karlsruhe sind:
Dr. Christian Gausepohl, Rottendorf Pharma GmbH
Markus Roemer, comes compliance services