Good Laboratory Practice (GLP) Scientific Support
This pharmaceutical manufacturer is contracting most of the nonclinical bioanalytical phase of good laboratory practice (GLP) studies at contract research organizations (CROs). Because of the number of studies involved, its study monitors were not able to provide the attention required to the bioanalytical data and reports.
Quality Assurance Consultancy was hired to provide this service. One of our experts performed a scientific review of the bioanalytical data of several studies at every CRO. The data of each batch was examined in the native software (generally Analyst) with particular attention to the following:
- Integration parameters
- Process used for re-integrations
- Batch acceptance based on calibrators, quality control and blank responses.
Additionally, the chromatograms were examined for possible interferences, or for improper integration. Up to three Quality Assurance Consultancy specialists reviewed all bioanalytical reports submitted by these laboratories, to verify adherence to the sponsor template, to FDA guidance, and to the consistency of the text and tables. The comments were sent to one employee at the pharmaceutical manufacturer, who coordinated the responses.
In most cases, our experts made requests for revisions to the reports before they were finalized and verified the changes before the reports were signed. All exchanges of documents were handled through the respective portals of the pharmaceutical manufacturer or the CRO. Several studies were required to be performed for submission to the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) because the company is in the process of developing a new sterilization process, both with a product that has never been approved for this use and with sterilizers designed by the company for this specific use. The company decided to perform the antimicrobial efficacy and some operator exposure studies in-house.
Outcome:
In addition to helping this company set up a GLP program for these studies, we provided regulatory and technical review assistance in the development of the protocols, writing standard operation procedures (SOPs) and drafting the study reports.
