Compliance and Quality management is crucial issue for almost any business, large or small. No matter what medical product your company manufactures or services, it’s a virtual certainty that you are beholden to an array of different regulations, both internal and from the FDA such as cGMP quality systems. Ensuring that your company remains in compliance with these regulations and proving the quality and safety of products and services at all times is something that can’t be left to chance.
The burden on recordkeeping requirements under the cGMP quality system regulations has been a key discussion point in the industry concerning the number of hours and cost to maintain these systems, and the time involved to always be prepared for those “unexpected” inspectional visits. According to a June 24 Federal Register notice, the cGMP quality system regulation roughly applies to about 8,924 companies — just for medical device-related companies alone. FDA inspections and enforcements are continuing to increase especially under the new rule of Commissioner Dr. Hamburg. New measurements are even being proposed to ensure that Clinical Sponsors take the necessary steps to ensure compliance, stating that “medical care of the patients in a clinical trial is just as critical as the quality of work, competency of staff and sponsor’s involvement, and the key to complying with regulations is to develop systems, training and monitoring.”
The pyramid is setting up appropriate quality system functions we’re all familiar with and complying to them – SOPs and document control, training with plans and records, performance monitoring, continuous evaluation through audits, managing change and corrective/preventive action plans (see The Food & Drug Letter, FDANews).
Although the FDA appears to be sympathetic to the industry, nothing much has changed. Interestingly enough the FDA is now seeking comments by August 23, 2010 on recordkeeping requirements under the medical device GMP quality system regulation (see June 24 Federal Register notice). But what about the FDA itself?
A recent report from the Center for Biologics Evaluation and Research (CBER) says that the Food and Drug Administration (FDA) devotes nearly half its staff to regulating various medical products, like devices, diagnostics, and drugs. Since the FDA has over 15,000 employees, this means that the US Government employs nearly 7,500 people for the express purpose of attending to this particular type of regulation. Granted, medical products are extremely important. No industry is more sensitive to mistakes or lapses in judgment than the health industry—and so it is, in a certain sense, a relief to hear that the FDA has a small army of regulators to attend to all these little details. But we can’t help but wonder if that large regulatory task force could be streamlined? 7,500 is an impressive number, but it’s an unwieldy one. How much human error does the FDA deal with on a daily basis?
In fact there has been a noticeable decline in the quality of warning letters – issues ranging from typographical errors, lack of legal support for assertions, delays in requests for information or citings, inconsistent decisions, to other duplications or missing reviews. Due to the increasing amount of warning letters to the industry, traditional agency policy (specifically for legal reviews) was changed to address only those with “significant issues.” FDA’s response to the decline points to retirement/turnover and new hires with less experience in handling matters. In an age of technology, why is the FDA still dependent only on its “experienced” but now gone experts, especially when it comes to compliance and quality processes? Where are the systems, training and monitoring within the FDA that they continue to spout? Yet the expectations for the Industry have not changed when it comes to inspections over documentation, change management, training, reporting and management oversight. The FDA is still really coming after the industry in a more aggressive manner, even on minor issues. The threshold has changed (The Device & Diagnostics Letter).
So why hasn’t the threshold changed for the FDA? Perhaps, the FDA needs to eat its own dog food when it comes to compliance and quality systems to have an easier time attending to the details of its own regulations and business processes. And by using technology to supplement its staff, they can reduce human error, improve its efficiencies, prevent the unpleasant and sometimes costly consequences that come from these issues, and only then, truly understand the demand on Industry.