Quality In The Global Pharmaceutical Supply Chain

By Pilgrim Software Inc.

Supplier quality has been a prime topic at recent industry conferences. Original Equipment Manufacturers (OEM) material suppliers and contract manufacturers attended to listen to the implications and driving forces behind the scrutiny of our supply chain. Although regulations and guidelines are already in place in multiple industries, supply chain complexity has grown from simple domestic sourcing, manufacturing and distribution, to a complex evolution of global sourcing, manufacturing and distribution centers around the world.

The great commotion that has caused regulatory agencies to be more focused in their scrutiny stems from the growing level of media exposure to patient health, with issues ranging from Heparin, Baby Formula, Spinach, Beef, Pet Food, Defibrillators and more. Warning letters citing deficiencies in production and process, specifically about purchasing controls, continue to increase. Agencies like the FDA, with new management, budgets and resources, will no longer tolerate long lead times for corrections. FDA’s follow-up has revealed the lack of due diligence of supply chains is wide- spread. Expectations from the new FDA commissioner, Dr. Margaret Hamburg, stated companies need to “act swiftly and aggressively to protect public health,” and cites that multiple warning letters will no longer be submitted. In addition, as part of her “top ten” list, Dr. Hamburg intends to focus on national and international partners to find ways to ensure that global and domestic companies secure their increasingly complex and ever-growing supply chains. Regulations will be tightened with requirements for compulsory audits (US and Eu-rope). What does she expect from companies? “The Solution is a commitment to compliance backed by a strong compliance program. Now is a good time to reassess whether you have such an effort in place.” The discussion from participants in these conferences is to not wait.