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Pharmaceutical Industry: Compliance Remediation

Capability

Operational Improvement
Regulatory, Compliance & Quality

Client

A major generic pharmaceutical company

Problem

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

Approach

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.

Results

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.

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