GMP-compliant Maintenance & Calibration - Online Training Recording

No downtime and no risk to products or patients are the main deliverables, a maintenance & calibration system should ensure. BUT it is also well known that the maintenance budget is among the first to be cut when cost-saving measures are being implemented. But still, a working maintenance system is a clearly written requirement in the pharmaceutical industry as well as in connected industries. See 21 CFR § 211.58 and 67, for example, as well as chapter 3 of the EU GMP Guide. Even as important as official requirements is the companies’ own interest in having high plant availability and in reducing the number of break downs. The same is true for calibration: having manufactured medicinal products with equipment which has exceeded its calibration interval can lead to a recall of all manufactured batches from that time interval, based on the criticality of the measuring device. Reliable systems for Maintenance and Calibration must therefore be in place.  Hygiene is another fundamental requirement in the pharmaceutical industry. It is an important aspect of maintenance work, that the equipment is set back to a cleaned operating state after maintenance or calibration, which has to be addressed in training and in the instructions for the maintenance work.

Another GMP specific aspect is the documentation of maintenance and calibration. Very specific requirements from traceability to the four eye or double-check principle exist and must be met. Calibration certificates not meeting GMP requirements are frequent inspection findings, especially when the calibration has been sourced out to a contractor

In this course we will combine the understanding of the regulatory background and the design of a maintenance system as well as the training of practical aspects occurring in the daily maintenance work:

Examples will help to understand the basic requirements and how they can be fulfilled.