Maintenance of the validated state

Maintenance of the validated state

Maintenance of the validated state is no less important than the validation itself. Upon completion of proper validation and the launch of production, the object of validation / qualification moves into the state of operation and maintenance.

This means that from that moment one should take care that none of the activities performed should cause the loss of the validated state.

Properly implemented “Maintenance of the validated state” allows to save time and costs, when managing existing and validated system and/or equipment.

The most common causes of the loss
of the validated state

What is also connected with the operation and maintenance state is also withdrawal from use.

The stage of withdrawal from use is also incorporated into the validation life cycle and requires taking appropriate action.

The most frequent processes being part of the maintenance of the validated state include:

We perform the following, among other things, as part of the maintenance of the validated state:

We develop relevant procedures and instructions

We conduct training and implementations as per the instructions mentioned above

We take an active part in incident management and change control processes (we review and assess changes, supervise scheduled actions, perform validation activities – for example, preparation of documentation and testing)

We perform periodic inspections

We do revalidation and re-qualification (to the extent identified in the risk assessment)

Find out how our validation experts can support you


Certyfication of medical marijuana

Are you searching for a GMP certification for your medical cannabis operations? Look no further than our expert team. We have a deep understanding of Good Manufacturing Practice (GMP) regulations and can provide you help with the necessary certification to ensure that your products meet regulatory requirements.

We make meeting regulatory requirements easy.