Through the years, our long-standing relationship with ALZA has resulted in the completion of nearly 75 projects by DPR. These projects have ranged in size from smaller jobs, such as a projection screen and shade installation, to meatier technical endeavors like a remediation project that involved converting 6,000 sq. ft. into four new tableting suites within an existing validated facility. This project, which was completed without disrupting production, also included upgrading 40 processing rooms to meet the new standards of the Medicines and Healthcare Products Regulatory Agency (MHRA), the European Union (EU) equivalent of the Food and Drug Administration (FDA).
The two-phase remediation provided DPR with an opportunity to assist ALZA in enhancing various programs that better integrate construction with the company's validation plan. For example, during the project, 140 Building Management System instruments were pre-calibrated, tracked, retired or post-calibrated, and a model tracking process (which has become the calibration department's primary tool for coordinating calibration work) was developed and initiated.
DPR self-performed the foundation for the tableting suites, drywall and framing; other subcontractor crews were available throughout the project for increased flexibility, permitting our teams to make progress in areas while steering clear of active production.
Both phases of the project were finished on time and within budget without sacrificing quality. In fact, the German inspectors from the MHRA were extremely complimentary and made the general statement that this remediation project serves as a model of how they would like to see other pharmaceutical companies respond to similar types of upgrades.