5 Keys To Supplier/Purchasing Controls – And Product Quality
By Fran DeGrazio, executive editor
![]()
Issues stemming from poor quality in drug and device development and manufacturing can negatively impact patient safety, as well as disrupt supply or lead to product shortages. Such issues often result from insufficient or ineffective approaches to supplier or purchasing controls. A recent FDA warning letter illustrates the very real consequences of a biopharmaceutical company not attending with enough diligence to one of its critical suppliers.
This warning letter reinforces the importance of qualification and oversight of a Contract Manufacturing Organization (CMO) used to manufacture pharmaceutical products. It emphasizes that a sponsor company must understand what is going on at its supplier/CMO. The letter also clearly expresses that the pharma company is ultimately responsible for the quality of its drug product, regardless of how, where, and by whom the manufacturing was done.
The expectation that supplier/purchasing controls play a critical role in ensuring quality management and compliance became even more evident with the FDA’s introduction in early 2024 of the Quality Management System Regulation (QMSR). (See my recent take on the QMSR here.) This regulation amends 21 CFR 820 by incorporating by reference the quality management system requirements set by ISO 13485:2016 – Quality Management systems – Requirements for regulatory purposes. This revision also extends to Part 4 – on maintaining cGMPs for combination products. For instance, the combination product owner must clearly describe how it chooses suppliers and provide clearly specified product requirements.
So, what can biopharmaceutical organizations do to put into practice increased, effective supplier/purchasing controls? I recommend five foundational considerations, as follows:
#1: Apply Risk Management Principles
The FDA reinforces the need for risk management to be fundamentally incorporated into the Quality Management System (QMS) of any biopharmaceutical organization developing combination products. It suggests that ISO 14971:2019 Application of risk management to medical devices be incorporated, although it is not mandated. With or without a mandate, sponsor companies should not only apply risk management but also position purchasing controls as, among other things, an aspect of managing risk.
In evaluating the suppliers it relies upon, a sponsor company must assess the relative degree of criticality of each supplier to its products and processes and, from a risk management perspective, treat that supplier accordingly. For example, a supplier of raw materials used in several of a sponsor company’s drug products likely poses a higher degree of potential risk than does the supplier of raw materials for just one product. If something were to happen to that cross-product supplier or to its raw materials, the potential for widespread impact would be greater and, therefore, so would the degree of risk.
Continue Reading…
Issues stemming from poor quality in drug and device development and manufacturing can negatively impact patient safety, as well as disrupt supply or lead to product shortages. Such issues often result from insufficient or ineffective approaches to supplier or purchasing controls. A recent FDA warning letter illustrates the very real consequences of a biopharmaceutical company not attending with enough diligence to one of its critical suppliers.