Harmonization of Calibration, Maintenance and Validation

Have you ever seen a pharmaceutical facilities department with four heads?  It’s the stuff of fireplace folklore.

Long, long ago, swamps once untouched by man thrived with these beasts, until such time as their reclamation, making way for the pharmaceutical and biotech companies now in their place. This forever displaced the beings long indigenous to their native environment, but their legacy lives on in the corporate offices replacing their former home.

These beasts sit atop GxP facilities, overseeing calibration, maintenance, validation, and associated QA / CAPA activities. Collectively, they’re quadra-lingual – completely fluent in each discipline, but no single head talks the other languages fluently. Therefore, they don’t always converse with one another effectively. Calibration does its own thing. Maintenance and validation departments diligently carry out their duties, and QA frantically attempts to maintain continuity between the three areas.
Singly, each entity has the right idea on what needs to be done to properly maintain, calibrate, validate and document the activities so often performed on the same set of regulatory assets. Again, however, we begin to lose sight of the big picture when lack of communication between the different groups prevails. This is particularly true where one activity performed requires follow up or documentation by another group to maintain a validated state.

It’s not at all uncommon to see non-routine maintenance activities performed on equipment that requires follow up calibration and validation, where a subsequent lag-time occurs in communication, inadvertently leaving the affected equipment in an active state. The same can be said for lag-time in notification of calibration failures and validation discrepancies to the applicable stakeholders. Another issue lies in the fragmented documentation generated by each group for common assets, making a paper trail nightmare. While record keeping requirements are similar, lack of harmonization between the activities themselves, their quality review and record retention leaves a black hole. Inspection teams are keen to search for and write citations for these anomalies, and at least as far as the FDA are concerned, the QSIT (Quality Systems Inspection Technique) approach is paving the way to make these issues more transparent than before.

I’ve long stood on the CAT (Criticality Assessment Team) soapbox as well, and for many reasons, fiscal, regulatory, and others, the harmonization efforts instilled within are well worth the implementation of such a team.

Implementation of business/equipment management systems that bring together the disparate disciplines of asset management can do wonders in harmonizing the management, scheduling, data collection, and documentation associated with keeping processes, instruments and equipment in a validated state in regulated production and critical research environments. These systems prove useful in keeping all business organizations concerned with common regulatory assets apprised of this validation status, as well as what documentation and remedial action might be necessary to implement the necessary CAPA.

While the design and commissioning of these systems/practices is often time consuming and documentation intensive, the return on investment is well worth the effort, and is in many cases, required by regulatory bodies to maintain continuity across the board in asset management.