When Janet Woodcock of the FDA said, "We have to move to a quality culture," she gave quite a good summary of the status quo of the pharmaceutical industry in matters of quality. First of all, let us look briefly at how endeavours to establish quality in the pharmaceutical industry have developed within the last 100 years. This branch of industry has evolved during this process from quality control through quality assurance and on to quality management (Figure 1).
And yet many companies still hesitate to implement a working quality management. Is this because quality management has a far broader scope than GMP requirements currently dictate?
Figure 1: From Quality Control to Quality Management
An analysis of many pharmaceutical manufacturers would reveal that a large proportion of them are still situated in phase 2, quality assurance.
However, in the recent past the FDA has repeatedly emphasized that a new quality culture is needed in the healthcare sector. The FDA does not focus here on the pharmaceutical industry alone, but rather it also expressly includes governmental institutions and other partners in the healthcare sector such as hospitals and physicians.
For this very reason, the industry must not be allowed to disregard these expectations. There is more involved than GMP compliance alone. This is about a new quantum leap in comprehension, covering the range from quality processes to a living quality culture.
A living quality culture has a significant impact on all aspects of a company and is actively supported by them. At the same time, employees are encouraged by appropriate systems to do things correctly. “Right first time.”
The first thing many people think of when they hear this is production. But how often do we start off by selecting the wrong suppliers (purchasing), choosing employees without exercising due care (personnel), deciding on a technical system that fails to meet specifications (engineering), providing too little training in word processing for employees (administration), etc.
Every moment of our work includes quality aspects, whether we are
What matters is being able to relate all activities to quality. Because of this, quality management permeates all departments of a company.
The pharmaceutical industry can learn a great deal from other industries in this respect. Especially principles of quality such as the PDCA cycle (Plan - Do - Check - Act), continuous improvement or Kaizen provide a solid basis for the continued development of the quality system. But it is also vital to keep the further development of employees in mind, too. Development from quality assurance all the way to quality management is a process of change that management must actively promote.
Therefore, a living quality culture has a far wider scope than GMP compliance. The following questions could help you better assess your company.
Question 1: Does your company implement only a very few changes in the manufacturing process on the grounds that the effort and expense of executing process changes are too high?
Question 2: Do you review all quality parameters before a product is released, or do you take parameters into account from the in-process control for the release?
Question 3: What do you spend more time on: optimising operating procedures or processing and documenting deviations?
Question 4: Do you consider the Quality Unit to be your point of contact for optimising quality throughout the company (not merely for production)?
Question 5: Does your Quality Unit have appropriate methods available to optimise communication processes?
Question 6: Does good communication belong to the quality requirements of your company?
Question 7: Does your Quality Department make as many mistakes as Production?
Hopefully, you will be able to answer the last question with a clear "yes," for mistakes are made at any time and in any place; it is merely a question of whether or not they are recognised. The focus in dealing with this question is placed all too often on production.
There may be many more questions to consider in order to judge the quality maturity of a company. However, it is more important to take the first steps in the right direction. Even if one of the most important quality principles is, "right first time!" at the same time you cannot get along without trial and error.
An all-encompassing quality management with a living quality culture is also a good economic investment for any business operation. Companies in other branches of industry have shown in the past that they can significantly lower costs with the aid of quality management. I am convinced that this is also possible in the pharmaceutical industry.
Why not get started right away?
I hope that no such question will be asked anytime soon during an FDA inspection. For some it may not be easy to find a convincing answer.
Maas & Peither AG, GMP Publishing