Pharmaceutical manufacturers are lucky in that Validation and Qualification provides
a massive guide for the design of the maintenance regime – sadly sometimes they don’t know it. A chasm can exist
between project managers and maintenance.
Validation
of new pharmaceutical manufacturing facilities requires that equipment be Qualified. This essentially means that the required
performance and capability of the equipment is determined at design or selection and that when built or installed evidence
is produced to prove that it meets those requirements. Regulatory bodies may wish to see that evidence.
Sadly Qualification criteria are often viewed as a matter for installation projects only.
After handover, the documents are filed away and gather dust.
The
Qualification criteria might be pulled out periodically and the equipment rechecked against them. Although better, this is
still not the best solution. It is a lag check. In other words it only finds a problem after it has already occurred. The
quality of product already made, and perhaps already distributed, may be suspect.
The better solution is to design a maintenance regime that aims to keep the equipment performing within
its Qualification limits.
Each Qualification Criterion should
be examined to determine its durability, stability and vulnerability. The way it might fail (and here I use ‘fail’
in the sense of no longer perform within the acceptable limits. So, a motor that should be running under given load at 1350
– 1450 rpm has failed when running at 1300 rpm even though it hasn’t stopped completely). Maintenance regimes,
ideally those that use indicators to predict failure before it occurs, should be set up.
Examples
of Qualification criteria and suitable maintenance regimes:
