A key requirement of ensuring that a product is made correctly is ensuring that everyone who contributes to the production of that project is correctly trained. An example that’s easy to understand is an operative that cleans the room or location that manufacturing takes place in. That operative must know the limits of their responsibility and be competent in ensuring that their work is completed to a clearly understood standard. If the operative fails to clean the manufacturing environment a contaminant may get into the final product which may cause a batch rejection, or worse. Everyone involved, even indirectly, with GMP must take personal ownership of their standard of training and their work.
Within European Good Manufacturing Practice a special and distinct role exists, the Qualified Person (QP). The qualified person is a senior member of the quality team that is obliged by law to review the sourcing, manufacturing, testing and quality assurance of the batch of product to be released. Their approach must represent the pinnacle of GMP knowledge and outlook.
The power of using a Qualified Person is personal accountability. It ensures that the ultimate decision to release a batch of product into the market is traceable to an individual decision point. This helps ensure that organisational concerns such as profit making can be balanced better against what is best for the end user.
While a QPs role is daunting with the European GMP framework its always vital to remember that a QP will rely on the experience, training, honesty and compliance of the members of her/his company to be trained in what they do and to do the right thing.
The Qualified Person's Notebook 