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Anticipating and meeting challenges of regulatory authorities

Anticipating and meeting challenges of regulatory authorities

1. There has been an ever-increasing level of regulation in the international drug industry over the past several years. What is driving this trend? Do you see it continuing into the future?

Looking back over my 33-year career, I recall that the quality systems we had in place when I entered the industry were very rare indeed, and whatever did exist was quite limited. Essentially, we had only the German Drug law and very few regulations. At that time, we did not even do media runs. Can you imagine an aseptic manufacturing operation today where media runs do not take place?

Regulation within the drug industry continues to increase, and has led to much stronger quality systems. This is particularly true over the last few years. This increase is being driven by the regulatory authorities themselves. For example, the FDA is one such regulatory body that has increased its observations during inspections and with it, ensuing regulations.

The primary change I see is data integrity. Recently, there have been a number of incidents where a company’s data was falsified or poorly documented. As a result, we now have regulations from the British authority MHRA (Medicines and Healthcare products Regulatory Agency) and the WHO (World Health Organization). And, in the near future, we will have a revised Annex 1 to the EU GMPs Guideline.

However, no one has a crystal ball that can foresee exactly which new regulations will exist in the future. That is for time to tell.

2. What have been your greatest challenges and how have you managed them?

One primary challenge is, and always will be, inspections by regulatory authorities, particularly the FDA. Over the last few years, there have been a number of FDA inspections that have led to the need for additional investments in equipment and personnel. Our quality oversight department, for example, has had a continuous increase in tasks as a result of these FDA inspections.

As such, we make every effort to remain in contact with regulatory authorities. We also cooperate with our local authority as well, and participated in meetings with the FDA concerning quality metrics. Further, given the large number of authority inspections we have at Vetter, we make every effort to remain current with any new thoughts about regulation that the authorities may have.

On a few occasions we have had challenging inspections. One recent challenge I recall was an inspection performed by an authority. The primary challenge was actually the manner in which it was performed. Because there was no open discussion or dialogue, the situation was somewhat tense. Nevertheless, at the end of the day we managed to complete the inspection with just a few observations. We adequately responded to them.

3. What is Vetter doing to anticipate and meet the future demands of international regulatory authorities?

I participated in my first FDA inspection in 1988. Since then, I have been involved in 44 more FDA inspections. Nine authority inspections took place in 2015, along with 39 customer audits. That is the nature of our business, and why we need to do everything we can to try and anticipate and meet the future demands of the international regulatory authorities.

The continual improving of systems to achieve the high level of quality that meets international regulatory standards is our goal. If our systems are not according to regulations, customers could have difficulties entering markets that are regulated by these authorities.

That is why we recently announced our intention to invest approximately 300 million euros to expand and upgrade our manufacturing facilities. These upgrades are being driven by a changing healthcare market that is affected by issues such as ever-more complex molecules, smaller batch sizes, and increasing regulatory requirements. As a leading contract development and manufacturing organization, we are continuously developing our manufacturing sites and techniques to prepare them for future needs and requirements.

4. How do you feel about continuous increase in regulation in the drug development and manufacturing sector? Can there ever be too much regulation?

The Pharmaceutical Industry is one of the most highly regulated branches of government. This is normal given the nature of the work that we do. For that reason, we should not expect that the level of regulation will change at any time in the near future. In fact, we anticipate an increase in regulatory oversight over time.

At Vetter, we work hard to stay abreast of what regulatory authorities expect from our industry and try to anticipate what they are considering for the future. With that information we improve our systems accordingly. That is how Vetter conducts its business on a day-to-day business, and one of the key reasons why we never experienced the problems with authorities that other CDMO’s have.

Vetter is a global CMO for aseptic fill & finish contract manufacturing

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