Our quality systems are a key element of the service we offer to our clients.
Our independent quality assurance department has expertise in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and VICH-GCP (Veterinary Good Clinical Practice).
All our 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 interactions with our clients. In addition to ensuring our work complies with regulatory guidelines, we are committed to delivering studies on time and within budget. Our most recent inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) was in October 2021.
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. GLP studies are also compliant with the OECD Principle of Good Laboratory Practice 1998, OECD Series on Principles of GLP Compliance Monitoring No. 1.
Moredun Scientific has been a member of the UK GLP Compliance Programme since 1992. Our most recent inspection by the MHRA was in September 2020.
In our Animal Health and Aquaculture businesses, Safety Pharmacology, Target Animal Safety studies and Environmental Toxicology studies are compliant with GLP standards. In our Biosafety, Testing business our in vivo studies are as defined in relevant guidelines and are also compliant with GLP standards.
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 Medicines and Healthcare products Regulatory Agency MHRA, in October 2021 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 in Regulation B17 of The Human Medicines Regulations 2012 (SI 2012/1916) (as amended) and The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) & In compliance with Good Manufacturing Practice laid down in Regulation 5 of the current Veterinary Medicines Regulations.
In our Biosafety Testing business, all microbiology tests are carried out as defined in relevant guidelines and are compliant with GMP standards.
VICH-Good Clinical Practice (VICH-GCP) is intended to be an international ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analysing, and reporting clinical studies evaluating veterinary medicinal products.
Guidance has been developed under the principles of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and provides a unified standard for the European Union (EU), Japan and the United States of America to facilitate the mutual acceptance of clinical data by regulatory authorities – VICH-GL9 (GCP).
In our Animal Health business all clinical studies evaluating veterinary medicinal products are conducted to VICH-GCP standards.