3rd Quarterly Update 2006
Release procedures for medicinal products, requiring the intervention of a Qualified Person, may present problems to pharmaceutical companies. In particular those companies manufacturing quite a number of small batches per day and over a period extending the usual office hours, will face troubles in having a QP stand-by at any moment to sign-off the release documents. One of these companies now has called in our help to restructure the release procedure to solve this problem. The solution will include modifications of the release documentation as well as IT-structures to simplify document traffic between the manufacturing site and the various QP’s responsible for final product release. We expect to get this system up and running in Q4 and we hope that this system will “release” this company from a growing annoyance.
More “release stuff” required our attention this quarter as we had to release an investigational medicinal product for a Phase-I study done by one of the major global CRO’s. As this particular product concerned a biotech product produced in Asia, the EU Clinical Trial Directive calls for a EU-release by a European Qualified Person. Obviously EU-GMP regulations require any QP to be familiar with the manufacturing site of the products which he or she releases. And therefore one of our colleagues went on the plane to visit this Asian company, was received cordially by his Asian colleagues, and subsequently audited the manufacturing site. As this particular company was fully aware of the European and American GMP-regulations, no critical non-compliances were established paving the way for the product release.
Within the regulatory affairs domain we were involved in a particularly interesting project: defining the regulatory status of an innovative cigarette-substitute. Presumably you may hear or read more of this product in the near future. As the smoking of traditional cigarettes will be prohibited more and more, even in the open air, this company foresees a growing need for such alternatives. Apart from this very typical project, business is “as usual” in this domain with a number of long-time customers as well as new clients requesting temporary support to fill in vacancies caused by managers moving on to “new challenges”. In addition to this, the usual flow of generic submissions passed our office this quarter. And this steady flow still can easily accommodate any new project, so if you would be interested to “go with the flow”, please be our guest.
