The US Pharmacovigilance Team (USPV) completed a 3-day remote audit with its business partner Northstar Health. The audit, which was conducted virtually owing to COVID-19 restrictions, involved various teams including Global Pharmacovigilance Operations, Compliance & Training, Pharmacovigilance Quality Assurance, Safety Evaluation Risk Management, Quality Management System, IT, Clinical Quality Assurance, Local Quality Assurance, US Legal, US Regulatory Affairs and US Commercial groups. The auditors were impressed with the robust PV system that Glenmark utilizes to ensure patient safety, as well as with the knowledge of interviewees that came across in their informative presentations. The 3-day audit concluded with no critical, major or minor findings.
The positive outcome of the audit was a testament to USPV’s unrelenting teamwork. During the weeks leading up to the audit, the team worked tirelessly over long hours to ensure all aspects of the PV system were covered. Everything ranging from documentation of required trainings, to the completion of the local Pharmacovigilance System Master File (PSMF) in its entirety, and to providing evidence that ‘corrective actions preventive actions’ or CAPAs and deviations were successful. Additionally, the mock audit sessions organized by PVQA were vital in ensuring our interviewees were fully prepared. Pre-audit documents that were requested prior to the audit were prepared and shared on time by USPV which helped guarantee a smooth start to the audit. The audit was an impressive and inspiring collaboration of Glenmark representatives from different corners of the world (US, UK and India) who worked as a cohesive unit to support USPV.
Northstar Healthcare and Glenmark Pharmaceuticals Inc. (GPI) have a PV agreement that spans 13 products in the US Territory. Northstar Health is a leading international supplier of generic pharmaceutical drugs and a wholly owned subsidiary of the McKesson Corporation. McKesson is an industry leader in generics pharmaceutical distribution. Northstar Healthcare and Glenmark initially entered their agreement on 13 April 2018 with 3 products. Since the inception of the agreement, the number of products has grown to 13. The list of products include rosuvastatin calcium tablets, atomoxetine capsules and atovaquone oral suspension as the top 3 products with the highest US market value. Market value is defined by the total sales generated for products in GPI's portfolio [source: IQVIATM November 2020].
The following pictures include Christopher and Anitha in the Mahwah Office Conference Room during audit, as well as a picture of the very happy team during the final debrief meeting on Zoom