Process Validation Batch Release Deviation Management
Technical Transfers Aseptic Processes GMP QA Operations Fill Finish Packaging
Automation tool saves 50% in batch activities.
A leading international pharmaceutical company was launching a vaccine for the COVID-19 virus. Therefore, they needed to set up different teams in a short time to support all activities related to technology transfer, specifically in the aseptic and filling areas for the different Contract Manufacturing Organizations (CMOs). In addition, they required assistance monitoring GxP compliance at all sites and ensuring that all batches released complied with health authorization requirements.
In less than two months, we onboarded six experts in aseptic processes to support the technology transfer to the different CMOs globally. These consultants worked on an as-needed basis to act as a conduit between the client and the CMOs in Europe and South Africa. These professionals included:
Persons in Plant (PiP) to support manufacturing, filling, packaging, and quality activities.
Technical Integrators to validate processes, support deviation, and complaint investigations, and troubleshoot manufacturing issues.
Aseptic Experts to improve process validation and evaluate the existing aseptic processes to ensure GMP.
Product and technical transfers of vaccine products from manufacturing sites of the client to CMOs.
A team focused on batch release activities to review and ensure the compliance of all batches from different sites that were released in a short time due to the urgency of the pandemic. This team was also dedicated to controlling the deviations and proposing CAPA to assist the CMO teams.
In the following months, we onboarded 10 more consultants, all experts in aseptic processes, for all other activities related to deviation and batch release.
As the pandemic was an urgent situation affecting the world, the primary goal was to ensure that the vaccine was released properly and in the shortest time.
As a result of the consultants’ efforts:
Process implementation and validation of one production line was completed
An automation tool was implemented, saving 50% of time for certain batch activities
A lack of CTL documents or approaches was identified, and improvements and solutions were proposed
A new process flow was implemented for the manufacturing market
On-site monitoring of more than 45 batches for release according to timing for the different CMO sites was completed
These efforts have continued to strengthen our relationship with this client.