If you’re producing or importing pharmaceuticals, you’ll need a Qualified Person to confirm each batch is made according to the proper Good Manufacturing Practices (GMP) and Marketing Authorisation (MA). That’s the law! The final responsibility is in their hands and it’s a heavy weight on their shoulders. So, how can you help your Qualified Person to feel confident about product certification and when taking this vitally important decision? That depends! To start with, it makes a big difference whether the pharmaceuticals are imported or made locally, although the QP’s responsibility is exactly the same. Here are some helpful tips in both cases.
When working on a local manufacturing site it’s much easier for QPs to keep a close eye on quality. Procedures and people are accessible, so it’s simpler for them to stay informed and keep a close eye on changes, deviations, and generally make more of an impact than when they are a long way from the production line. Of course, the bigger the site, the harder this becomes. In this case, QPs will be more dependent on the quality system. Whatever the size of the company, focus is of the essence. After all, it is an impossible task to become involved in all of the daily detail, so the key is to keep control with a clear overview. In doing so, work with your QP to reveal the biggest risks and essential elements in the procedures, in order to highlight aspects that will require extra attention and inspection. For example, a new active pharmaceutical ingredient provider or sub-contracting laboratory. It is also well worth involving QPs in product quality reviews.
The task of a QP is much harder if the process is remote. Yet the responsibility remains. An important start is to establish a contract, in which the importer’s obligations under GMP and MA are clearly defined. Include a clear definition of deviation and change. Secondly, set up an audit, in which these requirements can be assessed. These should cover the entire process, and don’t forget to include every site involved in producing the product. Another important factor is to understand the level of detail that is required in taking a responsible decision. This means determining the risk. For example, take aseptic-filled product versus oral vitamins. The risks involved in a wrong decision are clearly quite different. In the one case, where life is potentially at stake, it will be important to control every aspect: checking measurements, forms and such like, in the same way as if the product were made locally. However, in the other case, where the impact is less severe, this level of detail may be unnecessary.
Effective communication is fundamental. A good discussion with your QP on a case by case basis will help all parties become clear on the most appropriate process. Then it’s down to you to respect the requirements and demonstrate adherence to the quality assurance system with the appropriate documentation … and help your QP sleep easy at night!