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Quality Standards

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 September 2020.

Good Laboratory Practice

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 as laid down by the Directive 2004/9/EC 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 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.

GLP Statement of Compliance

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 Medicines and Healthcare products Regulatory Agency MHRA, in March 2019 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 (medicinal products for human use) and 91/412/EEC (medicinal products for veterinary use).

In our Biosafety Testing business, all microbiology tests are carried out as defined in relevant guidelines and are compliant with GMP standards.

MHRA GMP certificate (veterinary products) 2019

MHRA GMP certificate (human products) 2019

VICH Good Clinical Practice

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.

Our experts

John Reilly

(CQI, RCA, MRQA)

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