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).
Open the Q-Met page for more information…
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.
Lesen Sie mehr… (externer Link)
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.
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
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
Lesen Sie mehr und zur Anmeldung…
Our business partner Montrium, Montreal, Canada, announced today the commercial release of the eTMF Navigator.
The eTMF Navigator leverages all of the information and documentation that surrounds your clinical trial and provides a visual, real-time, multi-dimensional view of TMF completeness. Clinical users now have the ability to manage their ongoing studies directly in the navigator by updating artifacts, sites or country information from a single location.The eTMF Navigator leverages all of the information and documentation that surrounds your clinical trial and provides a visual, real-time, multi-dimensional view of TMF completeness. Clinical users now have the ability to manage their ongoing studies directly in the navigator by updating artifacts, sites or country information from a single location.
Read more here: http://www.montrium.com/2016/04/montrium-releases-etmf-navigator-provide-greater-business-intelligence-clinical-trials
After MHRA and WHO have drafted their guidance documents on Data Integrity the US-FDA has published in April 2016 the Guidance for Industry for CGMP compliance (DRAFT Version).
The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practices. The guidance outlines US-FDA’s current thinking regarding the narrow scope and application of part 11 pending FDA’s reexamination of part 11 for 2003 as it applies to all FDA-regulated products.
Download at PDA the free code of conduct document for data integrity: Open External Link
For more information feel free to contact us at: talk@comes-services.com
