If your company encompasses a research based pharmaceutical discovery and development operation and you have identified a substance that may be considered for GLP compliant studies, we perform an assessment of the status of your development process to determine the measures that are required for GLP regulatory compliance, by performing a gap analysis. The gap analysis will be a step by step review of the components required for regulatory compliance with the GLP regulations versus the status of your operation.
Should any challenges be identified during the assessment, we provide assistance in answering those identified challenges; such as in the authoring of SOP’s; training of employees; establishment of appropriate documentation systems; review of analytical methodology; and authoring of validation reports to support the analytical methods. And as your development process continues toward IND filing, the development of specifications (tests, limits, units, methods) for raw materials, intermediates, packaging components, active pharmaceutical ingredients, dosage forms, and stability samples, are also available.
Audits of nonclinical laboratory studies (either of the client or a 3rd party CRO working for the client) are available to assess a firm’s facilities, operational systems, and documentation versus the requirements of Title 21; Part 58 of the U.S. Food, Drug, and Cosmetic Act; entitled Good Laboratory Practice for Nonclinical Laboratory Studies.
The audits will be conducted beginning with an identification of the laboratory animal studies performed, identification of the study sponsor(s), identification of the study director(s), and an overview of the goals of the study.
GLP status assessments
- Physical inspection of the interior and exterior of the facility
- Review of existing Standard Operating Procedures (SOPs)
- Review of employee training, and documentation of training
- Assessment of equipment to include proper calibration
- Handling of test and control articles to include stability testing
- Duties of QA personnel
GLP auditing services
- Prior regulatory inspections results including E.I.R.
- Physical inspection of the facility
- Review of the organization and personnel
- Equipment maintenance, calibration, cleaning
- Testing facilities operation
- Test and control articles
- Presence and elucidated duties of a Quality Assurance Unit
- Protocol for and conduct of the nonclinical laboratory study
- Records and reports
- Study data and conclusions
- Authoring of the audit report and follow-up