December 2017 Posts

Happy Holidays from the Pilgrim Quality Blog Team

Happy Holidays from the Pilgrim Quality Blog Team

It has been our pleasure this year to share with you our perspectives on the latest topics in quality, compliance, and risk management. We wish you a delightful happy holiday season and a prosperous 2018.
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Not-So-Standard SOPs: What You Need to Know

Not-So-Standard SOPs: What You Need to Know

Davor Milosevic, Quality Assurance Manager, Pilgrim Quality Solutions, an IQVIA company

Formal written Standard Operating Procedures (SOPs) are required both by the Food & Drug Administration (FDA) and European Medicines Agency (EMA). While the term standard suggests “business as usual,” there’s definitely nothing standard about what they represent. SOPs, in part, demonstrate compliance and say to inspectors that you know what you are doing and why.

However, for the last couple of years, SOP deficiencies have been one of the top findings in FDA audits on both the drug and device manufacturing sides. In fact, almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs, or lack of compliance in following them, within an organization. As such, the entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects or mismanagement of the related processes.
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Pharmaceutical Organizations: Are You Ready for the Unexpected?

Pharmaceutical Organizations: Are You Ready for the Unexpected?

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Unforeseen, unanticipated, unpredicted, unexpected. These are frightening words to pharmaceutical quality and compliance professionals because an unexpected event often indicates a costly, risky problem; it means that something is not completely under control.

This, of course, has regulatory implications. One familiar regulatory example is 21 CFR 211.192: “Any unexplained discrepancy…shall be thoroughly investigated…The investigation shall extend to other batches…that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.”
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Combination Products: Past, Present, and Future – Part 1 of a Series

Combination Products: Past, Present, and Future – Part 1 of a Series

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

The road to regulatory compliance for Combination Products has been a long one, and we’ve not yet arrived at our final destination.

At a recent AdvaMed Workshop in Washington DC, Pilgrim Quality Solutions, alongside FDA experts, had the privilege to present a Past, Present and Future perspective on Combination Products, diving into topics such as Product Registration (PMA, 510K); the De Novo pathway for Combination Products; Requests For Designation (RFD); Primary Mode of Action (PMOA); Labeling and Cross Labeling of Combination Products; CGMP; Adverse Event Reporting and Post Market Safety Reporting; and, Combination Product Inspections and Quality System Regulations.
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