Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.
For much of the rest of the world, the European Union provides a major model, with its directives, emerging CGMPs, and the ISO quality standards -- ISO 9001 for the majority of quality management systems, and ISO 13485 for medical device QMS.
All these regulatory requirements mandate that a company establish a ‘total quality system,’ from customer requirements through development, procurement (supplier control), production, to customer use and feedback.
Supplier controls are involved in all the above and are designed to require that vendor-supplied products and/or services:
U.S. FDA’s world view
FDA’s Commissioner Margaret Hamburg stated, in the U.S. FDA’s new “Global Engagement” Report, dated April 2012:
“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world.”
FDA Commissioner Margaret A. Hamburg, MD, as also quoted
in an April 23, 2012, FDA press release.
This in not just a U.S. issue but is a major concern for regulatory agencies worldwide.
In 2011 as one of the steps to meet this globalization challenge, the U.S. FDA opened the following operating resident posts in major areas of off-shore manufacturing for U.S. companies:
As a result, the FDA is 1) training their equivalents in those areas to current regulatory requirements / best practices, and are 2) auditing key offshore suppliers of major components supplied to U.S. manufacturers.
Know the source
It is incumbent upon manufacturers to know their suppliers throughout the supply chain, preferably direct to the manufacturer supplier, but, as is more likely, through intermediaries such as distributors:
The FDA expects that the end manufacturer ensure supply chain integrity and fight counterfeiting using existing systems such as the following:
UDI / GUDID: The FDA’s new device labeling requirement (UDI) with its global database (GUDID) [for more information go to the fda.gov website].
Some additional techniques / systems include:
Identification of the manufacturer and site:
This should also involve the certification of all distributors. All subject to the periodic confirmation of current information and changes.
The FDA both recognizes 1) the quality and safety advantages of documented CGMP / QMS systems versus 2) the economic advantage to those manufacturers who choose to “unlevel the playing field” by not playing by the rules with “adulterated product” in areas such as:
Note: FDA’s definition of “Adulterated Product” includes not just unapproved changes to a product but the non-adherence to cGMPs / specifications / SOPs, et al, in their manufacture.
Critical suppliers must be selected / qualified / retained ultimately by means of the
Non-critical suppliers may be selected / qualified / retained by means of:
Validity of the alternative / “desk” audit supported over time by:
Alternatives to the onsite audit, e.g., the questionnaire / paper audit, are less acceptable to regulatory agencies and are unsuitable for critical RM / components and APIs (active pharmaceutical ingredients) / excipients.
As shown above, the FDA recognizes that it is playing “catch up” to an existing global supply network with complex products, systems, and an outdated reliance on an “honor system” for imports that is not working. What it is doing is no different from what other industries have already implemented to protect themselves from dangerous counterfeit products and “knock-offs” and level the playing field. While specifics may change, the basic principles of supplier controls as outlined above will not be going away.