PLG Provides Module 3 Reformat and Update for Multiple Dossiers

Project Includes SOP Development and Pilot and Production Phases in Tight Time Frame

The client

French division of a large, multinational biopharmaceutical company

Project Description

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

ProductLife Group (PLG) was asked to reformat and update the Module 3 dossier for the client, to write the client’s related quality overall summary (QOS), and to manage the sign off on Module 1.4.1.

The PLG team comprised a chemistry, manufacturing, and control (CMC) project manager, four regulatory technicians, and three CMC regulatory consultants.

From the client side, there were a CMC manager and a regulatory coordinator.

The project included the development of a standard operating procedure (SOP) by PLG and approval by the client followed by a pilot phase before
the final production phase. Over a period of four months, seven complete marketing authorization dossiers were reformatted and updated, with three more dossiers completed in a second round.

The main challenge was to train the PLG team on the client’s dedicated tool bar, its word templates, and its specific rules for preparing and writing the dossiers. The rules were very stringent but were required in order to ensure the dossier would be in the format required for publishing.

The time from the initial training to the development and approval of the SOP, to the pilot and, ultimately, production was short, adding to the challenge — especially given that each modification required by the client had to be implemented to four dossiers at the same time.