Sharp Packaging Solutions is a company that works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry.
For one of their customers they were requested to implement an additional control system (Print & Verification) in an existing drug packaging line.
As a customer of Iperion, Sharp Packaging Solutions was looking for a validation consultant available on short term to assist with the validation efforts for this project.
The following validation activities were in scope:
- Risk Assessment
- Installation Qualification
- Operational Qualification
- Performance Qualification
The implementation involved the validation of the additional equipment and its functionality within the production line. The validation activities were performed according to the Risk Based approach as set in the GAMP 5, Good Automated Manufacturing Practices for Computerized Systems.
The project was supported by representatives of different departments within Sharp Packaging Solutions and had a challenging deadline. They were therefore looking for a person with not only the validation and technical experience, as well as experience in EMA and FDA regulations, but also the necessary soft skills to complete this project in a short timeframe. The project was completed successfully and Iperion did not just carry out the tasks involved in this project, but emerged to be a true partner. Iperion was able to bring insight in certain situations, acting as a kind of “linking pin” within the different levels of the organization.
Tom VandeBroek, Lead Validation at Sharp Packaging Solutions is very satisfied about Iperion’s performance: “Iperion has conducted this project with the high level of technical and GxP expertise to complete this project within the predefined timeframe in combination with the quality that is required for the customer.”