Regional Quality Control Laboratory (RQCL)

Our analysts carry out a wide range of tests, including:

• Product sterility testing – we have a purpose-built clean room on-site
• Microbial detection, enumeration and identification
• Determination of endotoxin levels
• Raw material analysis and identification testing
• High performance liquid chromatography
• Atomic absorption/emission spectroscopy
• Infra-red spectroscopy
• Disintegration and dissolution testing
• Refractive index, optical rotation, viscosity and density measurements
• Sub-visible particle counting
• Water content by Karl Fischer

Water used for medical purposes must be evaluated for its quality before use. We provide a full spectrum water analysis service: identifying contaminants, root causes and mitigation strategies based on current best practice and a wealth of experience.

We can perform full chemical and microbial analysis to comply with a variety of specifications, including The British Pharmacopoeia and Choice Framework for local Policy and Procedures (for endoscopy, clean steam and feed waters).

Routine tests include: endotoxin testing, TVC and trace analysis of contaminants (e.g. lead, calcium, magnesium, silicates and phosphates). 

Pharmaceutical products can be contaminated during production by the presence of residual APIs, medicines or other materials present in production areas. It is a requirement of GMP that validated cleaning procedures to prevent this contamination are in place.

We provide a comprehensive Cleaning Validation service at RQCL. We will send you a bespoke kit for the sampling of your facility to enable validation of your processes. Using HPLC, we will carry out trace analysis on your samples for residual contaminants. Additionally, a full report detailing the results of the analysis and the method and equipment used will be produced. 

We provide a full environmental monitoring service, from on-site sampling through to plate reading and microbial identification. We can measure for contamination of air, water and working environments within healthcare and other establishments. This allows us to provide complete qualification of pharmaceutical clean rooms.

Our aim is to provide benchmarking, early warning and remedial action data appropriate to your environment. We have access to the very latest diagnostic platforms, including MALDI TOF Mass Spectroscopy used for the rapid species identification of micro-organisms.

We offer a comprehensive temperature mapping service for validation of storage areas. Using lightweight, unobtrusive, portable data-loggers, we provide tailored methods to meet your requirements.

We will provide you with an appropriate number of data loggers which will be placed in designated positions inside the storage unit. After a set monitoring time, they will be collected and returned to RQCL, where data analysis is carried out. Our results are presented in a clear and concise manner, allowing you to determine easily whether there are any variations in temperature across your storage unit.

We map a wide range of environments, including incubators, fridges, freezers, stability cabinets and warehouses.

Assigning suitable expiry dates to medicines is of vital importance. We are able to test a wide variety of dosage forms to ICH and NHS QA guidelines, ensuring that medicines remain safe to use throughout their shelf life.

We assist in drug formulation design and assessment of formulation/packaging changes, to help improve patient safety and drug stability. A common requirement is assessment of tablets after repackaging in compliance aids. Through a combination of assay, degradation analysis and dissolution testing, we can provide detailed stability data.

A typical stability report will contain a scientific discussion of results, with statistical analysis where appropriate. Considerations which may affect product stability and formulation/storage suggestions will also be noted.

We offer a comprehensive range of medical gas testing services to hospitals, dentists and industry. We have two fully trained and registered QC(MGPS) professionals who can ensure that your system meets the criteria set out in the HTM2022/HTM02 and The British Pharmacopeia. Whether you want routine regular checks or testing following recent works, with our help you can ensure the safe and continual supply of gases to patients.

This service is primarily carried out by our experienced Quality Assurance Pharmacist. It is designed to consider the compliance of aseptic units with accepted quality assurance standards, including Quality Assurance systems, record keeping, premises and facilities. Following the audit, you will receive a detailed report of the findings. This service is available to those departments that engage in the preparation of pharmaceutical compounds, and is particularly useful to those who are not registered with the MHRA.