Mindful Compliance: Where Knowledge and Regulations Meet - - BioPharm International


Mindful Compliance: Where Knowledge and Regulations Meet

BioPharm International

Management Knowledge Management knowledge is the collective awareness and experience of applying the management arts in exercising its responsibility to adhere to applicable laws and regulations, meet customer expectations while economically controlling product quality, and provide dividends to stockholders. Management weaves together people and business processes that can acquire and utilize process knowledge, identify and control risks, and envelop the operation in a quality system.

Senior management of a drug manufacturer met offsite to review the state of the business and chart its future course. The finance, marketing, and sales departments gave presentations. Charts were projected and trends noted and explained. Data were compared to the previous quarter and year-to-date. The financial picture was less than optimistic, and this management group was tasked to respond. The company's quality improvement program suggested ways to reduce the cost of goods sold (COGS), accelerate the new product launch, and reduce associated costs. There was also the perennial challenge of reducing company headcount.

Many of the suggested changes were pushed through and rewarded in order to capture the savings in the next quarter. Cheaper suppliers along with a progressive approach to getting them on the approved supplier list quickly netted material savings and a reduction in headcount in the auditing group. Launch quantities of the new product were projected to be ready three months early as a result of retrofitting existing equipment and using existing validation templates. These and other changes were greatly facilitated by the use of planned deviations while the quality department caught up with procedure revisions and paperwork.

Management failed to recognize that it was creating the conditions for the loss of control — with financial and regulatory consequences far greater than the anticipated savings. Management lost touch with its process knowledge, risk knowledge, and quality system knowledge. Rather than directing its attention to achieving a greater understanding of the "sweet spot" where economic control of quality exists, suggestions were implemented without regard to the potential effects. Unfortunately, a perfunctory view of the quality system enabled the changes without challenging the effects of the changes and the probability of risk to the business. The quality system was viewed as a paper exercise. The financial loss from the delayed entry into the market was only exceeded by the long-term effect of being third to enter the market.

The manufacturer had a management process to review trends and to authorize and implement initiatives to respond to business needs. However, mindful compliance requires that management possess knowledge that enables it to facilitate product and process integrity and detect and control unwanted variation. To accomplish this requires professionals who can design a quality system that is an asset to the business. Quality professionals must be able to develop, present, and defend quality system metrics relevant to the business. They must be diligent and objective guardians of process and quality system changes, requiring data-driven and risk-assessed changes. And they will first seek to reduce cost by implementing an efficient quality system, eliminating nonconformance and capturing cost savings, and promoting intolerance for repeated deviations with the same root cause.

Conclusion There is a shift to a compliance paradigm that is rooted in knowledge of process and risks. Arguably this may represent a swing to the middle ground between the historically science-based approach to inspections used by the biologics side of FDA and the more legalistic approach used by the drug side. This does not mean that one approach is right and the other is wrong, but it does mean momentum is building to grasp the essentials.

Good things happen when we are reminded to focus on the essentials. I say "reminded" because Deming, in 1931, said we need to continually search for better knowledge about materials, how they behave in manufacture, and how products behave in use. He proclaimed that economic manufacture requires statistical control of the process and measurements. Deming was a proponent for process improvement in every feasible way.

This then is a short definition of mindful compliance: where the business of medical product manufacturing and the promulgation of regulations and guidance find a common ground of scientific and technological operations knowledge.

Suggested Reading

  • FDA. Guidance for industry, PAT— a framework for innovative pharmaceutical manufacturing and quality assurance. 2004 September. Available at: www.fda.gov/cder/guidance/6419fnl.pdf.
  • FDA. FDA unveils new initiative to enhance pharmaceutical good manufacturing practices: a risk-based approach. 2002 Aug 21. Press release available at: www.fda.gov/bbs/topics/NEWS/2002/NEW00829.html.
  • FDA. FDA announces new progress toward "21st century" regulation of pharmaceutical manufacturing. 2003 Sept 3. Press release available at: www.fda.gov/bbs/topics/NEWS/2003/NEW00936.html.
  • Shewhart W. Economic control of quality of product. Milwaukee (WI): American Society for Quality; 1989 (1931).
  • Snyder J. Deemed and redeemed: principles of justification for deviation reviewers. Journal of GXP Compliance 2004, 8(3):6-14.
  • Snyder J. Preparing for FDA inspections: before, during and after. Journal of GXP Compliance 2003; 8(2):182-188.
  • Snyder J. Commentary: conference report. Journal of GXP Compliance 2003, 7(3):6-9.
  • Snyder J. Corrective and preventive action: planning to achieve sustainable GMP compliance. Journal of GXP Compliance 2002; 6(3):29-39.
  • Snyder J. Management responsibility for the quality system: a practical understanding for the CEO in FDA-regulated industries. Journal of GXP Compliance 1999; 3(3):55-59.

John E. Snyder is president of John Snyder & Company, Inc., 245 County Road 4581, Boyd, TX 76023, 940.433.5044,
, http://www.johnsnyder.com/.

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