Customer context & PLG activities
Project Includes SOP Development and Pilot and Production Phases in Tight Time Frame
French division of a large, multinational biopharmaceutical company
Once the SOP was put in place, the CMC regulatory consultants gathered from the initial marketing authorization dossier and the respective variation files the Module 3 documentation to be reformatted. For each section, the files to be used were tracked and saved in the relevant folder — for example, certificates of analysis for section 3.2.P.5.4 and stability data for section 3.2.P.8.3.
After their reformatting, the dossiers were reviewed by the CMC regulatory consultants before a final review by the CMC project manager, who also was responsible for writing the QOS and signing
off on Module 1.4.1.
The finalized documents were sent to the client by using the client’s specific platform.
Risk factors and requirements
- The biggest risk factors for this type of project are the time restrictions on the training and pilot phases in order to meet tight deadlines. When a customer has a specific tool and stringent writing rules, it is necessary to write a specific and detailed SOP and to make sure that the team is properly trained before starting the production phase.
- To ensure the project met the client’s goals and timelines, PLG put in place rigorous organizational oversight of the team