PTS Seminar: GMP Datenmanagement – Behörde und Industrie im Dialog

Seminar, 30.03.2017 in Unna bei Dortmund

Bedeutung des Data Governance Systems für die Pharmawelt:

  • Von messbaren Datenparametern: Sicherstellung von Datenintegrität, Vertraulichkeit, Verfügbarkeit, Authentizität, Verbindlichkeit
  • Von der Datenerhebung und Datenerfassung, über Datendokumentation, Datenverwendung / Prozessieren, Datenablage zur Datenarchivierung
  • Von Entwicklungsdaten, zu Prozessdaten, zu qualitätsrelevanten Freigabedaten, Qualitätskennzahlen zum digitalen Information Management über den gesamten Life-Cycle
  • Hin zur Frage: Was sind Faktoren der digitale Wertschöpfungskette in der Pharmaindustrie?

Lesen Sie mehr zu diesem PTS Training…

CCS – 100 – business customers reached in 2016

comes compliance services (CCS), a leading GXP consulting service provider, for Pharmaceutical Quality Systems, Data Governance and Integrity, Computer System Validation and Inspection Readiness Programs, today announced that it has acquired more than 100 business customers since the launch of its services in 2009. Pharmaceutical and Medical Device customers rely on the compliance and consultancy services since many years provided by CCS. About 80 % of CCS projects are repeat-business and sales continue to ramp steadily. Continue reading “CCS – 100 – business customers reached in 2016”

Draft PIC/S Good Practices for Data Management and Integrity

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 This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities.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.

Download: PI_041_1_Draft_2_Guidance_on_Data_Integrity_2

A new number: 8400!!

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.

Read more (external link)

Risk-Based Environmental Monitoring White Paper

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.

REDUCE RISK (Download White Paper)