Newcastle Pharmacutical Quality Control Laboratory

The Newcastle Pharmacy Quality Control Laboratory (QC) is an NHS laboratory staffed by Pharmacists and Scientists who have many years experience of working in the Pharmaceutical Quality Assurance field of both the NHS and in Industry. Our main role is to ensure that any medicinal product used by the Trust’s Pharmaceutical Production Unit (PPU) is “Fit for it’s intended use.” The laboratory analyses the raw materials, packaging components and the finished medicinal products to the appropriate Pharmacopoeial Standards, utilising all aspects of Good Laboratory Practice and Good Manufacturing Practice. We are routinely audited by the Medicines and Healthcare Products Regulatory Agency as well as the Quality Assurance departments of clients. Within the staff there are 4 people named as Qualified Persons (Investigational Medicinal Products) QP(IMP) on IMP Licence held by the Trust.

Newcastle Pharmaceutical Quality Control Laboratory

Services Offered:

• Providing guidance for Clinical Trial Investigators on matters pertaining to all aspects of the Regulations surrounding Clinical Trials following the issue Directive 2001/20/EC.
• The laboratory provides a Bacterial Endotoxin testing service for the North East Region using the Gel Clot method.
• Development, issue, implementation, and monitoring of standards and guidance relating to quality aspects of hospital pharmacy services and the management of medicines.
• Quality assurance and quality control of medicines.
• Quality audits of pharmacy technical services.
• Reporting, investigation and testing of defective medicines.
• Advise service on all aspects pharmaceutical quality assurance and control.
• Quality control of medical gas installations
• Training of healthcare professionals in all aspects of pharmaceutical quality assurance and quality control.
• Qualification and audit of temperature controlled storage areas.

Our modern Chemistry laboratory provides the following.
• The laboratory is well equipped to perform classical wet chemistry techniques as well as performing the more modern instrumental analytical analysis.
• The instrumental techniques used in the laboratory include: -
• UV/VIS and FTIR Spectroscopy
• High Performance Liquid Chromatography (Including gradient elution and a Diode Array Detector)
• Automatic titration including Karl Fischer
• Testing to pharmacopoeial standards
• The laboratory has the ability to develop analytical methods for individual customer requirements.
Contact Details:
Lab Manager:
Kevin Dawson
The Pharmacy Quality Control Laboratory
The Newcastle upon Tyne NHS Foundation Trust
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE27 0BP
0191 282 0367
0191 282 0349