Fully GxP MHRA compliant services
We offer fully GxP MHRA compliant services from Research & Development to Commercial manufacturing activities:
- GLP – Environmental Safety, Agrochemicals, Contract Research, Cosmetics, Food & Feed additives, Industrial Chemicals, Toxicological Studies
- GMP – Manufacture of RSMs (Registered Starting Materials), APIs (Active Pharmaceutical Ingredients), testing of IMP (Investigational Medicinal Product) and Finished dosage forms
- GCLP – Samples from clinical trials
We are also compliant with other quality standards:
- Alcumus ISOQAR certification ISO 9001:2015 Cert No 6725 (Bradford site)
Concept Life Sciences are regularly audited and approved by MHRA and customers (and FDA at our Bradford site), representing an excellent opportunity to share best practice and identify areas for improvements.
Our Quality Policy supports our commitment to quality, accuracy and customer focus.
Our quality policy
This policy covers all Quality Systems at Concept Life Sciences (CLS) supporting both regulatory and research and development activities.
The Quality systems will enable CLS to deliver products and services that meet both customers’ requirements and regulations, protecting its reputation while reducing costs and driving improvement. This will be achieved by utilizing the following activities:
- Quality planning: ensuring that quality requirements are addressed throughout the product and service lifecycle
- Quality control: focus on process outputs to ensure that the agreed and regulated standards are met
- Quality assurance: gives confidence that standards and requirements are being met
- Quality improvement: a feedback process that is determined by all the points above and the business requirements
By managing and interlinking cross-functional processes as detailed above, CLS will be able to provide consistent high-quality work and satisfaction to both the customer and the business.
CLS personnel (where site appropriate) will comply with the requirements of:
- Regulation No. 1252/2014 and Directive 2003/94/EC, applying to active substances and medicines for human use
- Directive 91/412/EEC applying to medicines for veterinary use
- In addition, Directive 2001/83/EC and Directive 2001/82/EC lay down related provisions
- GMP as directed in ICH Q10 and Eudralex Vol 4 part II
- GLP as directed by The Good Laboratory Practice Regulations. Health and Safety Statutory Instrument 1999 No 3106
- BS EN ISO 9001:2015 Quality Management Systems
In addition to UK and EU commercial legislation and regulations, CLS complies with all legislation and regulations specifically related to its business activities.
All personnel at CLS will ensure that they understand the requirements of this Quality Policy and commit to following the contents of their local Quality Manual.
All personnel at CLS will maintain and develop the Quality Management System (QMS) through collaboration and engagement by ‘owning’ the QMS.
Concept Life Sciences management commit to the following key objectives:
- Strive to be perceived by our customers as a company whose service and support consistently exceed those of our competitors.
- To meet/exceed client contractual expectations.
- In the event that one of our customers has a problem with our services or our actions, we will react immediately and decisively to overcome it.
- Work to build a company that is regarded by its employees as one they are proud to work for, that communicates with them, listens and responds appropriately, values them and invests in them.
- Provide training and a safe working environment.
- Strive to be the preferred supplier for our services in our chosen field.
- Provide high quality service which is compliant with all applicable GxP regulatory and statutory requirements.
- Provide a process for reviewing and improving quality objectives through process excellence initiatives.
- Communicate this work ethic to all employees and ensure the principles are embodied in the day-to-day culture of Concept Life Sciences.
- GMP Certificate (Human) - Bradford
- GMP Certificate (Veterinary) - Bradford
- GMP Certificate (Human) - Sandwich
- GMP Certificate (Veterinary) - Sandwich
- MHRA GLP Statement of Compliance - Dundee
- MHRA GLP Statement of Compliance - Sandwich
- MHRA GLP Statement of Compliance - Bradford