Context: 

 

International multi-sites biotech corporation, mixing old and fully new facilities under USP/DSP manufacturing processes.

Challenge: old facilities were facing difficulties in accommodating new manufacturing processes, generating QA out of specifications impacting batches release. A backlog of deviations and CAPA needed to be urgently resolved.

The Client was seeking external support through classical consulting assistance (time and materials).

There were also several internal projects underway and the client was keen to ensure that any learning and success factors from the non-conformity and CAPA backlog project was communicated and integrated into these in-house initiatives.

Fixed-price project based on deliverables, milestones and planning.

 

Objective:

 

To stabilize, clean and decrease the current deviation and CAPA backlog in 6 months by resolving 12 deviations and 30 CAPA per week while still respecting local procedures, impact assessment, good investigations practices, and risk managemen

This was performed using a fixed-price approach.

 

Approach:

 

BQG conducted a kick-off meeting with Client to scope out the project, agree objectives, project plan, timing reporting and key deliverables.

A 5-person task force from BQG was assembled. They followed an integration orientation to be trained on the tools they will be using, the client process and procedures based on BQG best practices to ensure they were effective from Day 1 of the project.

The BQG taskforce was on-site at the client site for the duration of the project

 

Results:

 
  • Deviation and CAPA back log decreased to zero two weeks earlier than planned.
  • Client was extremely satisfied with the results and speed at which this was addressed and appreciated the work ethic and professionalism of the BQG task force.
  • BQG were invited to stay and build another team to follow up on other deviation back logs.

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