The concept of the Qualified Person is exclusive to the European Union and was first established 1975. According to EU directives pharmaceutical companies must employ the services of a MHRA/VMD accredited Qualified Person (QP) to adhere to the following applicable regulatory requirements. Good Manufacturing Practice (GMP) for medical products (2003/94/EC)
Good Manufacturing Practice (GMP) for veterinary medicinal products (91/412/EEC)
Good Clinical Practice (GCP) in conduct of clinical trials (2001/20/EC)
Community code relating to veterinary medicinal products (2001/82/EC)
Community code relating to medicinal products for human use (2001/83/EC)
Companies that manufacture medicines and drugs for clinical trials can often find that increases in demand, new ventures or unexpected changes in personnel require the services of a contract consultant QP. The effects of a company not being able to release its product in to the market place as a result of not being able to meet the regulatory requirements could mean disaster for the profits, market share and reputation of the company. Organisations regularly use consultants to provide the final QP certification for the finished product by either taking full responsibility for the manufacture, assembly, packaging, labeling, storage, testing and distribution activities. In some cases, certification may require extensive auditing of sites which can stretch the existing resources. In this situation many companies have found it prudent to use a consultant QP as a smart solution to this problem. This is becoming a more widely used and acceptable cost-effective means of production and manufacture for companies without the appropriate QP cover. |
