Pharmacy Quality Control (QC)

The Pharmacy Quality Control Laboratory (QC) is responsible for ensuring that medicinal products used by the Trust are fit for their intended use.

This work involves analysing manufactured products, as well as the raw materials and packaging components used by the Trust’s Pharmacy Production Unit that are not readily available from the usual suppliers, to ensure they meet agreed specifications. Its responsibility extends to assessing the suitability for use of unlicensed medicines purchased - either from other hospital, ‘specials’ manufacturing companies, or imported from other countries – and for performing environmental and microbiological testing to ensure that the Pharmacy Production facility meets the standards demanded by the licensing authority. In addition, QC staff work closely with the Estates Department in monitoring the Medical Gas Pipeline System, which delivers medical gases including oxygen to the patient’s bedside.

Pharmacy Quality Control also has contracts with external organisations to provide them with analytical services similar to those provided to the Trust’s own Pharmacy Manufacturing Department (Newcastle Specials Pharmacy Production Unit ). Although not directly involved with patient care, it also has a wide role throughout the Trust and is involved in some part with much of the treatment provided here.

Within the Quality Control Department there are four people who are able to act as Qualified Persons as prescribed in the European Clinical Trial Directive 2001/20/EC and the UK Statutory Instrument (SI 2004/1031) entitled The Medicines for Human Use (Clinical Trials) Regulations 2004.