Quality Management is Frequent Swedish Inspector Finding

By Emily Hough, PDA

At the 2008 PDA/EMEA Joint Conference, Tor Gråberg, Chief Pharmaceutical Inspector of the Swedish Medical Products Agency, gave a presentation entitled “Inspections Update: Major Observations.” Gråberg presented data from inspections done by his Agency from 2003 to 2006. During that time frame, the Agency’s performed 136 inspections and recorded 2,809 distinct deviation observations.

Breaking down the numbers, Gråberg listed the top ten deficiency categories. Consistent with data presented by the U.S. FDA and other regulatory authorities over the years, documentation led all categories.

While it wasn’t the most cited deficiency, quality management was the most serious, according to Gråberg. “If you have a lack of quality systems, the most important thing is, what signal does it send out to the company? Normally, quality systems are the responsibility of the QA department, and if there is a lack in the QA department, it sends out the message throughout the company that quality is not that important, instead of sending out the opposite message. That is why these deficiencies are so valuable to look for. It is our belief that if you consider quality risk management, Q9, the new Annex 20—the Annex 20 itself is not mandatory, but quality risk management is—so in the future you will see the deficiencies cited to Chapter 1 when it comes to lack of quality risk management. That’s why it is important to have a thorough knowledge of Chapter 1 of the GMP.”

The Swiss inspector was not surprised that about the number of times quality management was cited because it is a relatively new concept. He likened the current experience with quality management to that of validation when it was a new concept. For a few years following the official expectation for process validation, it became a top category in the inspection data, but began to drop as “internal knowledge” about validation grew. Gråberg said he imagined that the quality management deficiencies will follow the same path.

“I expect what we will see is more deficiencies with quality management, and you can compare that to the development of validation.” In the beginning many firms were written up for not conducting process validation at all. Once process validation became ubiquitous, inspectors honed in on the content, leading to additional violations. “So you always start on the helicopter pad and go further down, depending on how well the company has understood the task—you will see the pattern. Although you have increased your workload for validation at the same time the outcome appears normally, you have increased the number of deficiencies as well. And then [the number of deficiencies] turns around again and decreases as a result of internal knowledge.”

Gråberg listed a variety of specific deficiencies that fell into the broader quality management category, starting with the quality system. “So that includes dealing with deviations, change controls and rejected materials.” Inspectors also cited firms for problems with “technical agreements” between contractors and customers. “In this case, the technical agreement between contract giver and contract taker did not explicitly point out who was responsible— responsibility for quality control, approval and release of starting material to production. Once again if you fail this very simple issue, it could be a disaster further down chain.”

Problems defining the quality person’s responsibilities also was cited. “This type of deficiency makes me wonder what is actually happening at that company because responsibly of the QP should not be something new for the industry. It should be in the back door; it should be very easy to understand and to implement the responsibility for the QP throughout the whole organization. So if you fail on this small patch, it sends us the signal that something else might also be lacking.”

Training was another “quality management” issue. “The training of personnel was inadequate. No program for introduction was in place. Same for repetition of GMP had not been performed. No system was in place to incorporate personnel who were absent during the training when training took place as well as external personnel. So even if you have a good system you need to follow-up; what about those who were sick that day, how can they take part of the training that was given?”

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