Quality Systems
Our quality systems are a key element of the service we offer to our clients. Our independent quality assurance department has expertise in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), VICH-GCP (Good Clinical Practice), ISO 9001:2000, ISO 17025 and ISO 14001. All regulatory studies adhere to either GLP,VICH-GCP or GMP standards.
We are regularly audited and inspected by both our clients and regulatory bodies to ensure ongoing compliance.
Our quality focus encompasses all our interactions with our clients; in addition to ensuring our work complies with international regulatory guidelines we are committed to delivering our studies on time and within budget.
Good Laboratory Practice
GLP is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies on pharmaceuticals, agrochemicals, industrial chemicals, food and cosmetics are planned, performed, monitored, recorded, archived and reported.
In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) carries out inspections to ensure that test facilities apply the principles of GLP as contained within Statutory Instrument No. 1999/3106, the Good Laboratory Practice Regulations 1999.
Moredun Scientific has been a member of the UK GLP Compliance Programme since 1992.
Our most recent inspection by the MHRA was in September 2008.
Our Statement of GLP Compliance is found here.
Good Manufacturing Practice
Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA) or product specification. GMP is concerned with both production and quality control.
Our most recent inspection by the MHRA, which confirmed that our operations are compliant with the principles and guidelines of good manufacturing practice, in relation to contract quality control services as laid down by the European Commission Directives 2003/94/EC and 91/412/EEC was in September 2008.
Our Statement of GMP Compliance is found here.
For further information on our Quality Systems please contact us: info@moredun-scientific.com