SMB Validation

Validation Project Management

Integrating packaging equipment from diverse and often, geographically dispersed manufactures requires particular attention and a high degree of validation project management. SMB Validation & Compliance Services Group is aware of this requirement and experienced in the skills of good validation project management.

During a recent major validation project Our task was to qualify a high-speed tablet packaging line. The various individual machines that had been specified for this line were built by one (1) Italian, four (4) US and two (2) UK based companies. And then integrated by a third party in the UK for a large German equipment manufacturer who, in turn, had sold it to a pharmaceutical manufacturing company in Singapore.

This project certainly needed a degree of planning (and flexibility) so as to ensure that it was brought to a successful and timely completion. Although the scope and locations may change the project described above is fairly typical of the projects that we are involved in.

As part of the project management activities a detailed Validation Master Plan is provided. It describes the activities, roles and responsibilities, and identifies where the process fits within the typical project lifecycle.