The benefits of the Qualified Person Advisory Service

The concept of a qualified person is unique to the European Union and was founded 1975.

According to EU 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 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)

The companies that manufacture drugs and drugs for clinical trials can often be found that increases in demand, start-ups or unexpected changes in personnel require the services of a consultant contract QP.

The effects of a society that is unable to release its product to market as a result of not being able to meet the regulatory requirements could mean disaster for profits, market share and reputation.

The organizations that regularly use consultants to provide final certification QP for the finished product to a complete assumption of responsibility for the manufacture, assembly, packaging, labeling, storage, testing and deployment tasks.

In some cases, certification may require auditing range of sites that can extend existing resources. In this situation, many companies have considered it prudent to use a consultant QP as a clever solution to this problem.

This is becoming more widespread and acceptable cost-effectiveness of the means of production and manufacturing for companies without the proper coverage QP .......