Quality & Values
QUALITY MANAGEMENT SYSTEMS
Good Laboratory Practice (GLP)
Alderley Analytical is proud to be Good Laboratory Practice (GLP) accredited, being a member of the Medicines and Healthcare products Regulatory Agency (MHRA) GLP monitoring programme, which means our laboratories and processes are regularly inspected. This allows us to support pre-clinical safety studies that require GLP compliance.
What is GLP?
GLP is a quality system associated with pre-clinical safety testing of a drug before it is first used in humans. Introduced by the Organisation for Economic Co-operation and Development (OECD) in 1982 and in 1997, the UK GLP regulations came into force; this ensures the uniformity, consistency, reliability, reproducibility, quality and integrity of pre-clinical safety tests throughout its 35 member countries.
Alderley Analytical is legally required to comply with the regulations for our pre-clinical safety studies to be accepted by regulatory authorities worldwide. GLP consists of a number of requirements to ensure the fully documented integrity of a pre-clinical safety study. It ensures that the organisational processes and conditions under which pre-clinical health and environmental safety studies are:
Planned, Performed, Monitored, Reported & Archived
This means that we provide clarity around the responsibilities of key people involved in the study, e.g. the Study Director, ensure Quality Assurance personnel are assigned to the study, keep our facilities and equipment maintained to the highest standards, use robust test systems, have documented standard operating procedures, monitor both the plan for and conduct of a study and finally report on and archive results in accordance with the regulations.
Good Clinical Practice (GCP)
As a member of the Medicines and Healthcare products Regulatory Agency (MHRA) GLP monitoring programme, Alderley Analytical are also periodically inspected for Good Clinical Practice (GCP) compliance by the same body. This means that we can claim GCP compliance when supporting clinical studies.
We ensure that analysis of samples from clinical trials complies with GCP regulations and that they are conducted in accordance with the EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples.
What is GCP?
GCP is an international quality standard that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
The recommendations, rules and guidelines on how good clinical research should be performed.
GCP provides assurance that study data and the reported study results are credible and accurate, that the rights, safety, integrity and confidentiality of study subjects are protected and that the studies are conducted to a high standard.
Vision and Values
When we founded Alderley Analytical, our mission was to improve human health by assisting with the rapid development of new drugs. We could see for ourselves how much the process of drug development was slowed down by inflexible corporate bureaucracy amongst larger CROs and promised to do things differently.
Our corporate values underpin our approach to both our science and our service and help us strive every day to achieve our vision.
To become the partner of choice for bioanalytical services, delivering scientific excellence and outstanding customer service, leading to successful, long term collaborations or partnerships with our clients.
Every client is equal and never made to feel like a small fish in a big pond.
We’re committed to our clients’ objectives just as much as they are.
We proactively invite feedback because we continuously tailor and improve our service.
We celebrate successes and never rest on our laurels.
We make sure our team are treated well and valued.
We listen and collaborate, never dictate.
We don’t go quiet when there’s something difficult to say.
We update even if there’s no update.
We use language that everyone can understand; no fluff or corporate jargon.
We’re approachable and easy to get hold of.
We love tackling difficult problems.
We’ll get our heads together and apply our considerable talent to solving our clients’ challenges.
We’re driven to deliver success for our clients, and by default, ourselves.