May 25, 2016

Reporting Quality Metrics to FDA

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

By Siegfried Schmitt

Q: We are a contract manufacturing organization (CMO), specializing in chemical synthesis of APIs. Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organization. What do you recommend?

A: As with all regulations or guidance documents, there can be various approaches to achieving compliance. Quality metrics need to be specific to each business and circumstance. For example, metrics will be different for a site that manufactures a large variety of products in multipurpose equipment in small numbers of batches, compared with a site that produces large volumes of just a couple of products in dedicated process trains.

In addition, it is crucial to ensure that all parties involved understand what will be measured and how to report these metrics. Ideally, metrics should be checked for completeness and correctness before they are presented to be signed. Quality metrics should also be collated, measured, and reported in real-time, not months later in an annual report. Real-time reporting not only saves time and is more efficient, but it reduces error in reporting and allows real-time reaction of the site to metrics, as needed.

The following are a few additional best practices to keep in mind when implementing quality metrics:

• Avoid using quality metrics to drive financial rewards, which can easily lead to behavior that is aimed at benefit maximization rather than improving quality.
• Understand that quality metrics alone do not drive improvements--it requires senior management to provide the required resources for these improvements.
• Achieving 100% perfection is rarely achievable, nor feasible. For example, reducing the number of deviations may be a laudable goal, but trying to have zero deviations is not plausible.

Measuring quality metrics is not only important because it is becoming a regulatory expectation, but because it is good practice to have in place for the benefit of your company. Therefore, it is important to implement quality metrics, but you must ensure that these are applicable to your unique circumstances and are measurable.

1. FDA, Draft Guidance, Guidance for Industry: Request for Quality Metrics (Rockville, MD, July 2015).

Tags: regulatory, FDA, contract manufacturing, CMO, quality