The Challenge

The FDA issued a warning letter to a major contract pharmaceutical company in Michigan for not having a compliant calibration program.  The company is a global corporation with annual sales approaching $1.5 billion.  Their challenge was to re-engineer their existing calibration program and retrain all technical staff members.  This solution included: system audits, gap analysis, policy and procedure development, calibration scheduling and tracking software implementation and validation, test equipment procurement, calibration department staffing and technical training.  After the development of the calibration program the following challenge was to provide the ongoing training to maintain a companywide consistent and compliant calibration program.

The Solution

Based on industry experience and project qualifications, PCI was selected as the company to provide the Calibration Program Re-Engineering solution.  A PCI Senior Consultant headed up a team which conducted system audits, developed gap analysis and developed a project plan for the for customer approval.

The project began with the development of a Calibration Program Policy along with many executable calibration procedures.  This was the foundation of a compliant Calibration Program.  Blue Mountain’s Calibration Manager™ software was installed and validated for use as a scheduling and reporting tool along with instrument assessments and instrument master specification report approvals.  Training was then provided to technicians and calibration coordinators (documentation specialists).  This was key to ensuring a successful program.  Additional training will be provided to all manufacturing, quality assurance, and engineering management to ensure the importance and value of a compliant calibration program was understood across the campus.  PCI continued to build this program by procuring necessary test equipment to provide proper test accuracy ratios for all calibrated instrumentation across the campus and additional test equipment operational training was provided. 

Once a process flow diagram was developed to display the overall flow of documentation for the life cycle of an instrument within the calibration program, quality assurance ‘sub’ programs were instituted as part of the overall calibration program re-engineering.  This sub programs included such activities as a calibration deviation reporting / out of tolerance reporting, documentation change control for critical instruments, labeling practices and cGMP documentation practices.

The Result

·  A cGMP compliant, engineering-sound calibration department was developed and new and existing resources were training to maintain this program.

·  This campus has maintained this complaint calibration program for more than 10 years with no material observations.   

·  The same calibration program was implemented by PCI at two additional sites of this company.

·  PCI has developed a long-term relationship with the customer to continue to provide calibration consulting, metrology laboratory support, and other services as the customer has continued to advance.

The Benefits

Benefits to the client include:

·  The customer now has a consistent, compliant Calibration Departments at 3 manufacturing sites, thus allowing the customer with the flexibility to share resources across sites.

·  Calibration program policies and executable calibration procedures are shared across sites.  

·  Calibration vendors are pre-qualified through consistent audits and the audit findings are shared across sites.

·  Reduced cost of implementation through the use of PCI’s quality approach.

·  Compliant calibration programs that clearly display evidence of control in FDA and client audits.

For additional information, contact:

Todd McCulloch

Senior Consultant

Pharmaceutical Calibrations and Instrumentation, LLC.     

              (919) 250-8387 Mobile

www.pci-llc.com