Enhancing Regulatory Compliance for a Pharmaceutical Manufacturing Company

THE CLIENT

A key player in a highly regulated pharmaceutical industry manufacturing over-the-counter vitamins and health supplements.

THE CHALLENGE

Our Enterprise Health Check assessment identified inadequate resources for regulatory compliance, leading to poor adherence. This resulted in compliance penalty fees and other incidental costs totalling GBP 2 million over the last fiscal year, including GBP 1.5 million in penalties and GBP 500,000 in legal and remediation costs.

ASSESSMENT

Lead Measures

Ratio of Compliance Staff to Total Employees: Only 1:100, well below industry standards.
Budget Allocation for Hiring Compliance Personnel: Just 2% of the total budget.
Number of Training Sessions Provided: Only 5 sessions in the last year.
Budget Allocation for Compliance Training: A mere 1% of the total budget.
Percentage of Total Budget Allocated to Compliance: Only 3%, compared to the industry standard of 5%.

Lag Measures

Number of Non-Compliance Issues due to Lack of Personnel: 20 incidents in the last fiscal year.
Number of Non-Compliance Issues due to Lack of Training: 15 incidents.
Number of Non-Compliance Issues due to Insufficient Budget: 10 incidents.

SOLUTIONS

Increase Compliance Personnel

Hire additional compliance staff to meet industry standards.
Allocate a sufficient budget for hiring experienced personnel.

Enhance Training for Compliance Personnel

Provide regular and comprehensive training sessions.
Allocate an adequate budget for quality training programs.

Align Compliance Budget with Industry Standards

Increase the total budget allocation for compliance to meet or exceed industry standards.
Regularly review and adjust the budget to ensure alignment with regulatory requirements.

RESULTS

Improved Ratio of Compliance Staff: Achieved a 1:50 ratio, reducing non-compliance issues by 50%.
Increased Training Sessions: Conducted 20 sessions, reducing training-related non-compliance by 60%.
Enhanced Budget Allocation: Increased compliance budget to 5% of the total, eliminating budget-related non-compliance issues.

CONCLUSION

This case study illustrates the critical importance of adequate resources for regulatory compliance in the pharmaceutical industry.

By identifying specific challenges related to personnel, training, and budget, and implementing targeted solutions, the UK Pharmaceutical manufacturer was able to significantly enhance its compliance posture. The transformation led to tangible improvements in compliance staffing, training quality, and budget alignment, resulting in a substantial reduction in non-compliance incidents. The experience underscores the value of a comprehensive assessment, data-driven insights, and customized strategies in achieving regulatory excellence, safeguarding both the company’s reputation and the well-being of its customers.

Note: The above values are estimated variables and are subject to change depending on the scope, volume, complexity, and unique circumstances of each client.