In response to Jagan
Hi Jagan
Generally we qualify equipment (and systems) and validate processes.
Qualification is comparison against specifications and requirements.
Qualification is a sub set of Validation.
Qualification consists of
DQ design qualification (EDR enhanced design review) consisting of URS-FRS-design review
IQ installation is confirmed.
OQ the system or equipment is set up and commissioned.
PQ the system or equipment has met the URS (defined as outer range of required operation, not the equipments range of operation, rule of thumb is that you should be using equipment at 80% of its stated spec, e.g.).
To complete the rest of validation you need to write the SOPs that relate to the equipment
operation and maintenance, cleaning, calibrating etc
To complete the rest of validation you need to confirm training.
You may need disaster recovery plans and de-commissioning plans.
The next part of validation can be Process Validation (PV). This is parameter specific for the products that you will be running. This can be measured using AQL's or Cpk or your own bench marks.
All of the above are subject to tailoring to the specifics of the equipment / systems.
i.e. Customised, Off The Shelf (OTS), dedicate to one product. Packing and filling processes, tablet and capsule processes. Water plants, HVACs , BMS systems, Utilities, sterilization processes, ERP systems, Computer Network
The above is using GEP to leverage IQ/OQ against installation and commissioning, this is the way the ISPE is leaning and saves on doubling up on the effort.
Note that there is a period of product development which normally occurs between PQ (the equipment / systems is qualified) and the PV. Carried out by the New Product Development teams.
Generally I use the terms:
"if we don't know the outcome it is a trial"
"if we know the outcome it is a validation"
I personally do not agree with the idea of validation trials. This is a contradiction of terms as you can only really validate a process that is in control and working (in theory).
To me these validation trials are process developments i.e cleaning process development, granulation process development etc etc. These are not the responsibility of the validation teams. If you go with the notion of "validation trials" then the validation team is now developing products, cleaning processes, packing processes. This depends on the size and structure of your organisation but roles and responsibilities are usually split between developing processes and validating processes.
Regards
PaulS
The above reflects my own personal views, ideas and observations and is not the linked to any organisation.
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