Pharmacists in manufacturing

Manufacture of a medicine involves many stages from chemical synthesis of the drug substance through production of the dosage form, quality control, packaging and distribution.

Manufacturing scientists plan, schedule and budget for materials for clinical trial supplies and commercial manufacture of the medicine. Pharmacists may also work in technical support where they provide specialist technical support to development and clinical manufacturing campaigns.

Quality assurance, including Good Manufacturing Practice (GMP), is vital at all stages and the pharmacy training is very relevant to this area.

A significant number of pharmacists in industry go on to achieve the status of Qualified Person (QP) – the individual responsible for approving every batch of medicine before it may be released to the market. Approval by a QP is a legal requirement in the EU. Large companies may employ more than one QP and a QP may also originally be qualified as a chemist, biologist, vet or medical doctor. The QP is frequently the key liaison link between the company and the regulatory inspectorate.