Biosafety Program Audit
About the Client
The Client, an international biopharmaceutical company, focuses on the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious disease.
Project Objectives
As a result of a rapid growth phase, the Client did not have the internal resources or expertise to conduct a thorough audit of their existing biosafety program.
What EORM Delivered
EORM conducted a biosafety program audit, including a review of the current biosafety program related to the Company’s current and future work with such materials as viruses, bacteria, and human-derived tissues or cell lines potentially contaminated with bloodborne pathogens. This audit and evaluation included:
- A review of the written Biosafety Program and associated procedures including: Biological Use Authorization forms, biosafety committee structure, pathogen and recombinant DNA review processes, checklists for researchers to use in order to ensure compliance with the program, and training materials;
- A visual inspection of the biological laboratory facilities and pilot manufacturing facility to verify appropriate equipment, controls and processes; and
- Interviews with key individuals in departments affected by the Biosafety Program.
EORM provided a summary of recommendations regarding the program review that highlighted the issues in need of improvement. This summary prioritized the findings and outlined the regulatory requirements associated the action. By providing the Client with this road map, they were able to develop an efficient and detailed plan for program improvement, required resources, and budget.
