Navigating regulatory compliance

Snapshot

Challenge: Pharmaceutical packaging company facing tight deadlines and resource constraints in aligning with the updated EU GMP Annex I regulations.

Results: The company is now well prepared and equipped with trained personnel, ongoing process improvement projects, a compelling business case, roadmap and tailored communication material for their customers.

Customer introduction

The company was a global player in pharmaceutical and MedTech packaging solutions, operating in over 30 locations. Their aim was to ensure that their pharmaceutical filling plants meet the revised EU GMP Annex I, ensuring marketability and support to their customers.

Problem

As of August 25, 2023, the updated EU GMP Annex I regulations would enter into force. The implementation project started later than desired, with ambiguity in interpreting the requirements and a lack of planning and resource allocation strategies. Moreover, their broad spectrum of customers held differing interpretations, which fell under the company’s responsability. Internal parties were not aligned on the need for Annex I solutions and standardisation. Basically, the company wasn’t going to be ready with solutions by the deadline, threatening potential sales and customer retention, while costs were set to increase due to the absence of standardization.

Solution

In November 2022, a multi-stakeholder task force of approximately 16 individuals started a gap assessment and interpretation exercise. The company turned to StingOrg in March 2023 , facilitated through the director of manufacturing who had already worked with our consultants before. The approach was adopted as follows:
• Rigorous project management and reporting in steering meeting
• Development of business cases and a roadmap for different departments
• Evaluate processes and identify improvements
• Protect product liability

One StingOrg consultant was assigned as the project lead, entrusted with achieving the project goals.

Results

Together with the task force team, the Stingorg project lead achieved:

• Documented training courses and roll-out on the subject of Annex I
• A framework schedule, containing all activities for development, project management, engineering, sales and marketing, service, qualification and validation, training requirements and budgeting activities
• Clear path and planning for the next 3 years facilitated by the road map and business cases
• Communication media created for customers
• Established offer clauses on product liability
• Process analyses carried out and process improvements initiated

Apart from achieving these results, the team’s motivation to implement the solutions increased significantly and drove the company to request extension of StingOrg’s services.

Conclusions

In the face of daunting regulatory changes and resource constraints, our collaboration with this pharmaceutical packaging company exemplifies the power of strategic planning and expert guidance. By embracing a proactive approach, aligning internal stakeholders, and harnessing StingOrg’s expertise, the company not only got on track for compliance with the updated EU GMP Annex I but also fortified its market position, enhanced customer relationships, and improved its internal processes.