Is your Quality System a Target for an Fda Warning Letter?

For life science companies, receiving a warning letter from the FDA is akin to a good hard spanking, and---if nothing else---it’s just a pain in the neck. After all, managing compliance, connecting quality processes and completing quality tasks (on time) has managed to remain a puzzle for most life science companies. Then again, it’s hard to argue with an organization that wants to assure the general health and safety of the American public.

So, what’s the solution?

Two Problems
There are two main compliance and quality related problems that face life science companies today. The first problem is faced by those life science companies that do NOT maintain a quality system and the second is faced by those companies that do maintain a quality system but spend too much revenue maintaining its management cycle.

Problem #1: Where’s the quality system?
E Med Future, a maker of NeedleZap(R), received a warning letter from the FDA and the implications inferred within its contents will remain immutable until E Med Future makes serious changes to a quality system that seems to have remained virtually nonexistent.

The Warning Letter Summary
The FDA’s warning letter1, addressed to a corporate officer of E Med Future, stands as a fierce example for life science companies that don’t have or maintain a quality system.

For example, The FDA noted within the contents of the letter a “Failure to establish and maintain a quality system that is appropriate for the specific medical devices designed or manufactured and that meets the requirements of 21 CFR part 820, as required by 21 CFR 820.5.”

The FDA also noted in the fiery letter that E Med Future “has not implemented…[a] complaint procedure, corrective and preventive action procedure, nonconformance procedures, and any other quality procedures, in violation of the requirement of 21 CFR §820 .20(e) that each manufacturer establish quality system procedures and instructions.”

In addition, and also according to the FDA, the E Med Future company had also failed to comply with 21 CFR 820.20 (b)(3) when, “Since June of 2006…[the] firm has not appointed a management representative to ensure that quality system requirements are effectively established and maintained…and to report on the performance of the quality system to management with executive responsibility for review, as required by 21 CFR §820 .20(b)(3).

The letter continues and describes additional failures which include all of the following:

• “failure to perform management reviews…”
• “failure to implement corrective and preventative action procedures including procedures for analyzing complaints, returned product, and other sources of quality data …”
• Failure to “address how the quality data will be analyzed, including what statistical techniques will be used to analyze the quality data.”
• “Failure to implement your written procedure to control product that does not conform to specified requirements, including failure to properly identify, segregate and disposition nonconforming product, as required by 21 CFR §820 .90. observed by the FDA but these initial accusations would be enough to leave any life science company shrinking for cover.”
• “Failure to establish and maintain rework procedures, including failure to document rework and retesting that is performed on finished devices, as required by 21 CFR §820 .90(b)(2).”

Most of these numerous faults were due to noncompliance with 21 CFR 820 which as many life science professionals know is the QSR or the Quality System Regulation and which is associated primarily (if not exclusively) with GMP (Good Manufacturing Practices) and/or the manufacturing stage of a life science product’s development. An observation that may be overwhelming for some life science companies is that manufacturing regulations are only a portion of those regulations established for the life cycle of a product. The FDA also mandates compliance with GLPs (Good Manufacturing Practices), GCPs (Good Clinical Practices) and other ‘good’ practices depending on the nature of the industry itself. Because compliance regulations can be so numerous and so broad, it is no wonder that companies like E Med Future often fail to comply. On the other hand however there are companies that do manage compliance, at least as far as the FDA is concerned. These are the companies that don’t receive warning letters in the mail but are losing money.

Spending Less for Quality System and Compliance Management
To recap, the problem that E Med Future faced was the creation of a quality system. Other companies, on the other hand, already have a quality system but find they are spending too much to manage it. For example, many life science companies implement paper-based systems for the management of quality and compliance related documentation. This procedure may seem to save companies money, but in the long run a paper-based system funnels money out of a company at an alarming rate. After all, a paper based system requires more personnel for management, more space for filing, more time to fix errors and to find documentation that is amenable to a state of incompletion, loss and/or destruction. In addition, many life science companies do not connect their quality related processes effectively. For example, the CAPA (Corrective and Preventative Action), complaints management and change control procedures (not managed at all by E Med Future) are managed by other life science companies but are often managed more slowly and with less-than-perfect levels of accuracy. For instance, customer complaints that should result in a CAPA investigation may take weeks (or even months) to process and route to the appropriate individuals and departments. By that time, the CAPA investigation will not prove as effective as it could have been during a real-time scenario. In addition, slow and inaccurate quality systems also cost life science companies the revenue they could have been earning if initial product development documentation and processing had been completed sooner, with the inevitable result of earlier approvals for manufacturing.

Quality System Technology: The Solution for Two Types
The solution for companies like E Med Future that need a quality system and for those companies who currently spend too much and don’t get enough returns out of their system, is to invest in quality system technology that electronically controls documentation and automatically connects quality system processes. When searching for a solution, life science companies should consider searching for a
GxP process management system that will streamline compliance and quality processes across the regulated product lifecycle instead of during the manufacturing process only. Now THAT is a quality system.

1 All of the quotes in this article were retrieved on
December 22, 2007, from the following Internet URL: http://www.fda.gov/foi/warning_letters/s6597c.pdf