A pharma company was facing several challenges related to GMP service provider control, which led to several findings during an inspection putting one of their manufacturing sites at risk of being closed. The pharma company reached out to BASE to support them in closing the gap; to create and implement a global, standardized process for GMP service providers.
Three successive steps ensured an improved process; First, an overview of existing processes was established, and the stakeholder landscape understood, revealing the process variation throughout the organization and the change management effort ahead. Second, SMEs and LoB representatives were involved in defining the new process during workshops and frequent follow up sessions, to ensure a sustainable solution and create ownership in a changing organizational landscape. Third, phased implementation using one site as a pilot verifying the approach paved the way to a successful roll out. A gap analysis revealed the work required for full implementation, and gap closing activities were initiated with BASE’s help before hand over to the customer for finalisation and continuous improvement
As the process affected a broad and large number of departments, it was critical that the process was kept simple, operational and well defined. Simple questions were asked to guide service provider categorisation and level of quality control.