Quality is at the core of Concept Life Sciences (CLS) services. CLS is committed to maintaining excellence into all of our systems and procedures, enabling us to continuously deliver high quality, compliant and scientifically robust results, products and solutions for our Customers.
As Quality is at our foundation, everyone within CLS is committed to maintain high quality, ongoing compliance and continually improve systems throughout the company, whether in the Research and Development or the Regulated areas of the business. Core quality practices such as the requirements of ALCOA+ and Continuous Improvement activities are applied at every level of the business.
Our Quality Policy supports our commitment to quality, accuracy and Customer focus and is endorsed by Management. All Personnel at CLS understand the requirements of the Quality Policy and maintain and develop the Quality Management System (QMS) through collaboration and engagement by ‘owning’ the QMS,and following the contents of their local Quality Manual.
The independent, skilled and dedicated Quality team work seamlessly with operational departments supporting scientists and our Customers by ensuring:
- Good Scientific Practices (GSP),
- Good Documentation Practices (GDocP),
- Data Integrity (ALCOA+)
- Robust, Repeatable, Fact-based, Consistent data,
- Systems are based on 5Ps (Procedures, Processes, Personnel, Premises, Product),
- Customer-focused project work.
The Quality systems employed at CLS enable us to deliver products and services that meet both Customer requirements and the relevant regulations. This is achieved by utilising the following activities:
- Quality Planning: Ensuring that the applicable quality requirements are addressed throughout the project, product or service lifecycle.
- Quality Control: Focus on process outputs to ensure that the agreed and regulated standards are met.
- Quality Assurance: Confirming that standards/regulations and requirements are met.
- Quality Improvement: Investigation and feedback processes that is determined by all the points above and the business requirements.
CLS has a global Computer System Validation (CSV) strategy which complies with regulatory standards and expectations (with a rigorous risk-based approach developed from the industry standard GAMP5 processes). A dedicated CSV Manager ensures all aspects of the computer system life cycle are considered, from initial validation prior to use, through regular review, to decommissioning and final retention of data.
CLS are regularly audited by the MHRA and our Customers, ensuring that our work is carried out to the highest standards, guaranteeing that best practice and identifying areas of improvement is a fundamental part of our quality system.
We offer fully GxP compliant services supporting the ‘Concept through to Clinic’ activities for our Customers by providing the following regulated activities:
- GMP – Manufacture and testing of RSMs (Registered Starting Materials), APIs (Active Pharmaceutical Ingredients).
- GMP – Analytical testing of APIs, IMP (Investigational Medicinal Product) and Finished dosage forms.
- GCP – Clinical trial sample analysis.
- GLP – Environmental Safety, Agrochemicals, Contract Research, Cosmetics, Food & Feed additives, Industrial Chemicals, Toxicological Studies.
In addition to UK and EU commercial legislation and regulations, CLS complies with all legislation and regulations specifically related to its business activities.