10.05.2016 |

LOGFILE No. 18/2016 – Problems with the Regulatory Culture

Problems with the Regulatory Culture

by Robert G. Kieffer, Ph.D.

Today there is much discussion of the quality culture in the pharmaceutical industry. Many professional organizations are seriously addressing this topic. Why, because we are realizing that the root cause of many of the pharmaceutical industry’s quality problems can be traced to problems with the culture. It is the premise of this paper that the current industry quality culture is very much influenced by the regulatory culture and that this regulatory culture has problems embedded in it. After describing what we perceive to be some of the deficiencies of the regulatory culture we will make some suggestions on how industry can overcome them.

The Regulatory Culture

(1) Regulatory Confusion
“To my knowledge, there's no detailed common understanding within the United States about what GMP compliance exactly means,” CDER Director Janet Woodcock frankly stated at an exclusive ISPE Executive Forum. She further stated that she struggles to understand what a quality organization looks like. She bemoaned the unnecessary complexity provided by the regulatory system in the United States.

(2) cGMPs
We forget that the c in CGMPs stands for current. I think that they are very much out of date. The pharmaceutical GMPs reflect the quality philosophy of the 1950s. Then the common thinking about quality was that one had a production unit that produced and another unit that inspected the product for compliance with quality specifications. Today we know that that system doesn’t work and besides it is very costly. Today’s philosophy of quality is that the producers must be responsible for the quality of their work, the product. This is achieved by a robust production process design and validation, and well-trained personnel who take responsibility for the quality of their work.

(3) The Role of the Quality Unit
Today’s regulatory environment puts undue emphasis on the quality unit for the quality system and for product quality. The quality unit has taken on many tasks that should be performed by production, engineering, technical services, human resources, etc. Frequently the quality unit does not have the capability of performing these tasks adequately.

It is worth remembering what was stated in 1979 by the commissioner in the preamble to the GMPs:

”Functions that are properly those of the engineering department or other specialized units because of their unique training and expertise should not be duplicated or usurped by the quality control unit. Where expertise is in other units, the responsibility of the quality control unit is to assure that such expertise has been utilized. In order to make clear that quality control functions may be performed by persons assigned to units outside the quality control unit, the Commissioner is replacing ‘perform’ with ‘be responsible for’.”

The modern role of the quality professional is one of process improver and quality promoter. He has the skill to design effective and efficient processes or at least facilitate the work of teams that are performing the design and its implementation. Furthermore he creates ways to sell and promote quality throughout the organization. Especially important is recognition of good performance. This is looking for the things that are done correctly and not only the mistakes or bad things. (2)

ICH Q10 on the Pharmaceutical Quality System (PQS) indicates that senior management should take the responsibility for the PQS. We are a long way from achieving that goal. We still rely on the quality unit for establishing and managing the PQS.

(4) Continuous Improvement
Everyone in industry and the regulators talk about continuous improvement, but the regulatory environment makes this very difficult. Currently it can take years to get approval for a change in formulation or a change in the production process. The requirements are not harmonized across the world and even within one market it can take up to a year to get approval. ICH Q12 claims to attempt to remove this obstacle. ICH Q12 aims for,

  • “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight”
  • Most manufacturing changes are managed solely under the company’s Pharmaceutical Quality System (PQS) without the need for regulatory approval prior to implementation.

I’m skeptical whether this desired state will be achieved in my lifetime. This has been an impossible dream for most of my 50 years in the industry. Regulatory politics is too big hurdle.

What Can Industry Do?

Although the pharmaceutical industry cannot change the regulatory culture directly it can influence it indirectly and it can improve its own quality culture. Some suggestions,

(1) First recognize that quality does not equal compliance. Compliance is important but is not sufficient. We estimated many years ago that 100% compliance with GMPs would only get you 10% of the points of the Malcolm Baldrige Quality Award. Aim high, aim for Operational Excellence.

(2) Implement ICH Q10. ICH Q10 is not perfect, especially since it does not include efficiency, but it is a step above GMPs. Ensure that senior management take responsibility for the development, implementation and continuous improvement of the PQS. Shift the responsibilities of the quality unit as described above.

(3) Change your culture. This will be hard work and will usually take many years to accomplish. (3) Perhaps the regulators will learn from you.

(4) Industry needs to educate and lead the regulators, not the other way around. This is one of the main tasks of professional organizations like the PDA.


1. Lori Clapper, Editor, Pharmaceutical Online, April 23, 2013
2. Robert Kieffer, “The Changing Role of Quality Assurance in the Pharmaceutical Industry”, PDA Journal, 2014, 68 313-31
3. Carolyn Taylor, “Walking the Talk”, Random House, 2005


Robert G. Kieffer. Ph. D.
RGK Consulting
4100 Ravenwood Court, NW
Albuquerque, NM 87107
Email: rkief81270@aol.com

Dr. Kieffer is a recognized authority on quality management and on quality system design, with over 45 years’ experience in the pharmaceutical and medical device, industries. He combines broad-based business, scientific and technical knowledge with skill as a teacher, facilitator and problem-solver. He has worked in over 50 countries.

Dr. Kieffer is a past president of the PDA, worked for Sterling Winthrop Inc for 19 years and since 1994 has been president of his own consulting business. He has numerous publications and presentations to his credit.