1. Compliance Remediation
PHARMACEUTICAL INDUSTRY
Client
A major generic pharmaceutical company.
The client was under intense regulatory scrutiny and had received a number of 483s over a 2 year span. The FDA identified the company’s Standard Operating Procedures (SOPs) as needing improvement:
SOPs were not up-to-date and contained procedural inaccuracies
Multiple SOPs existed for the same activities, and duplicate SOPs sometimes differed in instructions
SOPs were not being consistently utilized by staff
Departments were not taking ownership of SOPs
A team of Tunnell Subject Matter Experts reviewed and revised the company’s entire portfolio of SOPs. This team, consisting of experts in Manufacturing, Regulatory Affairs, Quality Assurance, Quality Control, R&D, Engineering, and Analytical Research, worked with the client’s process owners and staff to:
Conduct a Gap Analysis vs. current procedures by observing execution of the SOP activities
Interview process stakeholders to identify potential improvements or undocumented practices
Incorporate industry best practices into processes
Revise SOPs and prepare required change management documentation
Once fully implemented the improvement program will result in:
Gaps in instructions eliminated. Increased detail and descriptions added to facilitate consistent execution of the instructions
Reduced Deviations and Investigations from improper execution of tasks
Better training and preparation of new and existing employees
SOPs created in collaboration with Supervisors and Operators to improve compliance and reinforce a sense of document ownership
SOPs converted to “Step Action” format for ease of use
Process Maps created and added to facilitate SOP use and understanding
Pictures added to identify key components and actions
Over 8500 SOPs reviewed and revised; approximately 125 SOPs eliminated or streamlined
Problem
Approach
Results
PE-37