Due to increasing concerns about the drug supply chain, global regulators are taking a close look at companies’ purchasing control practices. Recognizing this, PDA’s first ANSI-approved standard, BSR/PDA Standard 01-201x, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries, provides a guide for purchasing control requirements throughout the product lifecycle.
PDA Chair-Elect, Susan Schniepp, and Distinguished Fellow, Regulatory Compliance Associates Inc., and former PDA Chair Martin VanTrieste, and President & CEO, Civica Rx, outlined the new standard in a June 24 webinar. Both Schniepp and VanTrieste served on the volunteer committee behind the standard.
Purchasing controls remain more important than ever, according to VanTrieste.
“If we think about it today, many of the recalls are for adulteration,” he explained.
In addition to providing a standard for purchasing control requirements, the standard also seeks to ensure that responsibility for compliance is shared at all stages through an entire organization. Ultimately, final responsibility falls to the management of the organization. The standard can be used by biopharmaceutical (both proprietary and biosimilars), pharmaceutical (proprietary and generic), medical device and combination product manufacturers.
While the standard expands requirements already defined for FDA-regulated products, manufacturers with products subject to regulations outside the United States may also benefit from the standard.
For one, the standard summarizes the key elements of the supplier selection, qualification, approval, management and control process, starting with determining when a new supplier is needed. The document then details requirements for supplier selection and control. Once a new supplier has been selected, the standard further outlines steps for supplier monitoring.
In particular, the standard encourages extensive communication between a company and a supplier and between a site and corporate leadership.
“There has to be transparency between the supplier and the client,” said Schniepp.
One way to meet the requirements of the standard is to develop the role of a Chief Procurement Officer, or an individual responsible for ensuring compliance throughout the entire procurement process.
“You can never delegate accountability,” emphasized VanTrieste. He went on to say that he hopes companies can use this standard to ensure quality in their procurement processes, leading to fewer recalls and warning letters.
“I think companies in general need to also get in sync with quality agreements,” added Schniepp.
BSR/PDA Standard 01-201x, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries can be purchased from the PDA Bookstore.
[Editor’s Note: Martin VanTrieste spoke about the purchasing controls standard in a PDA Letter "On the Issue" video.]