With significant market competition in the pharmaceutical sector, quality has rightly become the differentiator for many products and services.
High quality standards are at the core of our pharmacy production unit and we have our own well-equipped, dedicated quality control laboratory.
The laboratory operates under our Specials (MS) and MIA (IMP) licenses and is staffed by quality control experts, who have a wide range of capability for analysis and testing of medicinal products and raw materials.
The team analyses raw materials, packaging components and finished medicinal products to the appropriate quality standards.
The lab is capable of performing ICH-compliant stability studies in a range of conditions (accelerated, real time and cold-storage), including statistical analysis of the results to optimise shelf life allocation, and can provide data needed to support regulatory submissions.
Capability of the service includes:
- Multiple HPLC systems
- UV/Vis spectroscopy
- Sub-visible particle counting
- Atomic absorption
- Bacterial endotoxin testing service, using the gel clot method
- Wet chemistry methods
- Quality control of medical gas installations
- Qualification and audit of temperature controlled storage areas
- ICH storage conditions @ 40°C/75% RH, 25°C/60% RH, 5°C, -20°C
With recent changes in legislation and the introduction of increasingly complex supply chains, quality assurance demands have increased significantly.
Newcastle hospitals has a dedicated team of ‘Qualified Persons’ (QP) and quality assurance experts who are experienced in navigating the regulatory changes and maintaining access to revolutionary medicines for all NHS patients.
Our quality assurance team can support a wide range of activity, from service or product supplier audits and technical agreement review, to full contract QP services.
Whatever your query relating to the regulatory requirements for marketed or investigational medicines, regardless of the country of origin, the team at Newcastle hospitals can help resolve your problems and speed up your submissions with a higher chance of success.