Much like the United States, in Europe’s Pharmaceutical industry has several institutions and services that help to regulate medicinal products before they are sold to and consumed by the public. One of these service in the qualified person services or QP. Qualified person services are usually outsourced to people who are well trained the in the field of pharmaceutical regulations. The main responsibility of a qualified person is to make sure that all of the medical or pharmaceutical products are manufactured, assembled, and packaged in accordance to state and nation wide regulations. This clinical labelling, clinical packaging, and clinical storage process is performed prior to the product entering clinical trials project management stage.
Pharmaceutical packaging companies that provide qualified person services are vital to the safe use control of medicine. This requires that everyone with the qualified person services are well trained and have a full understand of every single aspect related to pharmaceutical and medical packaging, as well as pharmaceutical serialisation. They must all adhere to good manufacturing practices for medicinal products. To sum up qualified person services companies must ensure that:
- All manufactured products follow GMP regulations set forth by the government
- All the processes relating to manufacturing and testing have been validated/ This involves accessing and looking through various documentation for proof.
- Any and all changes that were made to the production of a particular product were authorized by qualified personnel.
- Every single piece of necessary documentation relating to quality control and production have been completed and reviewed by authorized personnel.
- All required audits have been completed in accordance to regulations.
Big pharmaceutical supply chain companies are required by law to use qualified person services for any and ll of their pharma packaging and any other relating factors relevant to quality control. As a vital first step before medicine is introduced to the pharmaceutical market, QP providers must meet the certification requirements and have experience in several quality control related processes in supply chain management. These forms of certification includes a diploma and university degree. The university degree must be in the field of pharmacy, medicine, veterinary medicine, chemistry pharmaceutical chemistry and technology, or biology. There are also equivalent courses with in Applied physics, organic chemistry, analytical chemistry, pharmacology, toxicology, microbiology and a few more theoretical and practical sciences. The study in these discipline will help you to not only understand but also fulfill the various obligations involved with qualified person services.