GLP Projects

Butterworth Laboratories first became a member of the UK Good Laboratory Practice (GLP) Compliance Programme in 1989, and continues to maintain this status for analytical chemistry and phys/ chem testing. As a result, you can be assured that the data resulting from the conduct of a regulatory study is of acceptable quality and is internationally recognised.

We run one quality system that incorporates the requirements of ISO17025, Good Manufacturing Practice (GMP) and GLP. All analytical testing is carried out to the same high standard. It is important however, that you inform Butterworth at a very early stage that the work required will be for a regulatory study. This is because the management need to appoint a study director or principle investigator for the project concerned, who then has legal responsibilities for the production of any study plans and resulting reports.

Butterworth divide GLP studies into two types:

• Type 1 - In-house studies where a study director is appointed by Butterworth management.
• Type 2 - Where Butterworth Laboratories act as an external test facility for a delegated phase of a larger study and a principal investigator is appointed. In this situation the client (being a GLP compliant facility themselves) is required to supply a copy of the study plan which names Butterworth Laboratories Ltd as an external test facility for the phase(s) of the study to be delegated. Any study plan amendments must also be supplied as they are produced.
  The quality assurance department also audits every study at the critical phases, reporting their findings to the management of Butterworth, the study director/ principle investigator and customers' own QA department.

For further information on the subject of GLP, please contact our Head of Quality Assurance & IT Manager David Hawkins

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