Providing innovative research and technical services to governments and businesses worldwide

GMP Facility Qualification

• Concentric can draw upon extensive, hands-on operations experience to help get your new facility or process up and running on time and within budget.  This operating experience can reduce costs, expenses, and extensive reworking of documents and procedures

• Master Plan Preparation

• A Validation Master Plan provides a road map of activities leading to successful commissioning, qualification, and validation of a new facility or major renovation. Concentric can help prepare a plan that is comprehensive and adds real value to your facility start up efforts, not just checking off a regulatory requirement.

• Qualification Protocol Preparation

• Concentric provides protocol preparation that is based on real life experience, with enough rigor to be valid, but devoid of non-useful testing requirements. Commissioning and Qualification Protocols are prepared by professionals experienced with your equipment and processes. The protocols are customized to meet your existing format, or we will work with you to develop a format that meets your needs.

  Working with the client, Concentric personnel draw on extensive operating and engineering experience to prepare documentation that is pragmatic, complete, and in harmony with existing documentation. For new facilities, we work with the client to establish documentation standards that will be in compliance and practical. In all cases, Concentric prepared documents offer a careful and professional presentation to regulatory agencies.

  After the documents are prepared, Concentric can help overcome the resource shortage often encountered when starting up a new or renovated facility or process.