Problem Statement
Client: Our client was a large global biopharmaceutical company and was working on different work streams of consent decree remediations. Our client needed someone to lead the remediation effort for the new Quality Control Lab Qualification and work with a third-party compliance team to obtain regulatory approval. The key requirement was to successfully complete the project on time to meet FDA commitment as the company was under a consent decree and there were financial implications of missing the schedule.
Expertise And Solutions
The client company hired PJI Biotech to lead the qualification of the new chemistry and biology lab, work with the consent decree team, internal Quality, third-party quality verification organization, and regulatory affairs to receive the regulatory approval for the new QC facility. PJI Biotech worked with client management and a contract validation company to select a team of 6-7 validation study directors to write and execute validation protocols and reports. The team was trained in on-site remediation procedures and a lab equipment validation plan (~100 pieces of equipment) was developed. The plan included details on how the equipment will be categorized based on risk and regulatory/USP requirements and the extent of validation required for each piece of equipment. We reviewed the schedule with site management and on-site staff on a daily basis and resolved the issues on a daily basis. We worked very closely with the consent decree third-party verification team to ensure that all the compliance requirements were met. All the required specifications and protocols were developed for execution and reports were completed. Each document was reviewed with a third-party verification team for approval. After completion of validation, a final lab regulatory approval assessment was completed with the third party and regulatory before the release of the lab for use. The lab was successfully released within 10 months. The project was completed on time and on budget.
Results
As a result, the client was able to complete the FDA commitment for lab remediation and release a highly quality compliant lab, in a timely manner, and also within the planned budget. The client was pleased with the results delivered by the team. The project was completed successfully due to a dedicated expert team with relevant expertise and effective project management.
Feedback
The client firm was very happy with the results. The Site Senior management was very impressed with the results because they did not think that the project will be completed on a schedule based on the volume and complexity of the project. The specific feedback is as follows:
“I cannot say enough about the fantastic job you (Dipti Gulati) did leading the project for our consent decree. Your expertise in lab quality was second to none and your management skills were outstanding. Your “can do” attitude and ability to deliver to the schedule were first-rate. Thanks for all your help.”