There are movements to harmonize GMP regulations across countries and even across product types. The International Conference on Harmonization has been established to harmonize GMP regulations across countries. In addition, the FDA recently released a proposed rule for Current Good Manufacturing Practice Requirements for Combination Products (Federal Register, Docket No. FDA-2008-D-0409).
In this proposed rule, the FDA completed a gap analysis of the drug, biologic, and device GMPs. The purpose of this gap analysis was to determine what GMPs apply directly to combination products.
(i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity (single-entity combination products); or two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products (co-packaged combination products)).
The proposed rule lays out the missing drug requirements for device combination products and the missing device requirements for drug combination products.
Although the rule appears to be fairly well done, I was struck with its limitation to specific combination products.
So, I ask a question.
“Why shouldn’t manufacturers implement all applicable quality principles regardless of what regulations established them?”
I have spent the last three years working on a project that compiles European,
I have conducted many quality system evaluations as an industry auditor, FDA inspector, and GMP consultant. I have found that using a single set of regulations has significant limitation. In the process of harmonizing multiple regulations, I found it imperative to look beyond the letter of the text and appreciate the quality principles that were intended in their creation. In doing so, I discovered that some quality principles covered in one set of regulations were not adequately addressed in another set of regulations.
With the proliferated increase in the legal profession and law suits, a company’s regulatory compliance liability almost seems secondary. How many examples can we identified within the last decade where a company marketed an Agency approved product to only be sued for large sums of money after the fact. The cost of these law suits can be much greater than the cost of receiving a fine or warning from a Regulatory Agency.
I am sure that we can all appreciate that all quality issues have a potential legal liability and Regulatory Compliance is not likely to be a viable defense in the event of a lawsuit.
In today’s environment, I think it is safe to say;
“Simple compliance to any one set of regulations has limited quality value.”
Therefore, managing your company’s auditing and compliance program to successfully complete Regulatory Inspections may be short-sighted and is not likely to improve product quality or reduce a company’s legal liabilities. Conversely, applying the underlining quality principle found across multiple sets of regulations is likely to result in improved product quality, reduced legal vulnerabilities, and successful Regulatory Inspections.
