Gap Analysis and Project Management

A US based company was using a CMO in Europe to manufacture a new product for registration and launch in US and the rest of the world.  The company was facing some challenges with the project management and the CMO’s responsiveness to the quality and compliance needs of the project.  ICS was contacted by the sponsor  to support their corporate QA during the Tech transfer, scale-up, manufacture of validation batches and testing.

 

The challenges faced were related to:

 

• QC analytical method validation and testing

• Manufacturing suite qualification

• Personnel and material movement between manufacturing  and warehouse

• Pest control

• Warehouse management

• Environmental control (manufacturing suites, raw material and finished goods storage )

• Manufacturing processes

• In-process sampling and testing 

 

ICS Maven Associate assembled a multi-disciplined team of subject matter experts including manufacturing, QA, and QC. We performed a comprehensive  gap assessment and presented to the client.

Together we developed a plan of action and our subject matter experts(consultants) were included as team members within the site operation team and Quality Control. The associate managed  the consultant team was the point of contact between the team members and the client, and oversaw the consultants, provided direction, and presented the respective reports to the client corporate QA.

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We managed our activities successfully throughout the project until the registration on time and well within the budget.