Jill Cernohous, Clinical Snr. Principal Advisor
Because of the direct impact to patients, significant attention is typically placed on the execution and quality of clinical studies. However, have you thought about the quality of your nonclinical testing laboratories? Waiting until the completion of studies to confirm Good Laboratory Practices (GLP) requirements have been met may be too late to salvage the data.
How GLPs Impact Submissions
Nonclinical safety studies, whether in vivo or in vitro, are relied upon by FDA to determine the acceptability of safety data submitted in support of research and/or marketing applications. Having incomplete or poorly documented data can potentially lead to clinical holds, preventing clinical studies from being completed or hold up reviews and lead to rejected submissions.
Safety studies included in submissions must be performed in compliance with GLPs. Guidelines are used to drive study specifics. Guidelines for laboratories conducting nonclinical studies are extensive and often device specific, containing many nuances, particularly when it comes to animal studies. While understanding and navigating guidance documents are important to the conduct of studies, GLPs are regulation, which carry the force of law. Meaning deficiencies can have serious consequences.
FDA continues to conduct regular inspections of nonclinical laboratories and inspectors are skilled in knowing just where the weak points typically occur in quality systems. The focus of GLP inspections generally includes the organization and personnel to ensure management involvement, appropriate training and an independent Quality Assurance Unit (QAU). Operations are also reviewed including SOPs to ensure processes are outlined in a manner to ensure quality and data integrity. Facilities, equipment, reagents and solutions, animal care, test and control articles, and records and reports are other areas carefully scrutinized. The most common findings have included:
- Organizational and/or personnel inadequacies
- Incomplete/inadequate/no study records
- Inadequate archiving
- Inadequate/no standard operating procedures (SOPs)
- Protocol deviations
If embarking on a new nonclinical study, sponsors need to consider whether the laboratory has a GLP Quality System as the landscape for GLP studies is changing. The FDA Proposed Rule on GLP for Nonclinical Laboratories, published on 24 August 2016, would require a complete quality system approach for nonclinical laboratory studies when intended to support a marketing application or for submission to FDA. FDA believes this will result in a more flexible framework to help ensure quality in planning, conducting and reporting nonclinical studies, and result in more reliable data for FDA to consider when making regulatory decisions.
Investing in an audit of your testing facilities is a smart move to mitigate risk. Not only can you ensure they have got robust quality systems, you can also evaluate the quality of your data. If you have questions about auditing non-clinical facilities, get advice from experienced research personnel. Contact Samantha Thrun at firstname.lastname@example.org or 952-224-2260.