Validation and quality assurance to achieve compliance
In 2017, a major pharmaceutical company faced the daunting challenge of upgrading its QC laboratory. With over 100 different instruments and equipment to replace, as well as new data integrity and compliance requirements, careful planning and expertise were needed. Many of the existing equipment/instruments had reached the end of their lifecycle and no longer met modern requirements for either data integrity or ER/ES. The company needed to ensure that the laboratory was both compliant with GMP standards and met the analytical capacity needs of the business. Of course, we were up for the challenge, but first let us tell you a little bit about this type of laboratory.
"A QC lab, or Quality Control laboratory, is the heart of an industrial organization, where products are carefully tested and analysed to ensure they are of the highest quality and comply with all regulations. From physical and chemical tests to microbiological analysis, it ensures that products are clean and meet all specifications. The QC lab is crucial in the production chain as it can detect problems before products reach the market" - Anders Christensen, Senior Expert Consultant & Project Manager.
We thank our expert Anders for that explanation and return to the mission. How extensive was the upgrade itself and did the company have a stated objective for the project?
The project involved replacing or upgrading over 100 different pieces of equipment and instruments. This ranged from simple equipment such as refrigerators, freezers, pH meters and scales, to much more complex systems such as spectrophotometers and chromatography systems. In addition, the work should not interfere with regular analytical activities, which required careful planning and coordination.
And yes, of course there was a clear objective. The company wanted to ensure that the QC laboratory had a fleet of equipment and instruments that met today's compliance requirements and effectively supported the analytical needs of the business.
Implementation in three sub-projects with clear strategies
The project was divided into three sub-projects of two years each. Our Plantvision team was involved from the start, supporting with validation resources, quality assurance and project management. One of the success factors was having a constant project team with the right skills and experience in validation and data integrity, ensuring that the work met both industry standards and regulations.
Multiple strategies for success
To face the complexity of the project, our project team used several different strategies:
- They created and used generic templates and implemented continuous follow-up of CC cases and validation documentation to reduce delays and changes.
- Time for technical trials was scheduled to explore different configuration possibilities for complex systems, increasing the chance of smooth qualification.
- Through their technical expertise, they were able to provide solutions for backup and recovery, which promoted efficient management.
- Active cooperation with the beneficiary partner was maintained throughout the project.
"Another important part of the project was to decommission replaced or upgraded instruments. For complex systems, this meant ensuring that electronic data (ER) was readable throughout the retention period. We achieved this by migrating ERs to newer systems or creating virtual machines to read data from older systems" - Anders Christensen
A summary reflection
As a result of the project, the company now has a QC laboratory with equipment and instrumentation that meets modern data integrity and documentation requirements and meets the company's analytical needs. Electronic data (ER) from decommissioned instruments were secured to be readable throughout the retention period. In addition, new working methods and templates were developed for the efficient management of validation activities.
The project was delivered both on time and within budget, resulting in a very satisfied client and a proud project team. Thanks to the good result, the company recently started a fourth project to continue upgrading and expanding the capacity of the QC lab and our experts have been trusted to continue contributing with validation resources and QA.
Are you and your company facing similar challenges? Perhaps you are unsure of what steps need to be taken to meet today's demands towards compliance and excellence?
Contact us and we will be happy to tell you more about how we can help your business move forward and upwards.
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