after URS or after receiving an equipment
After receiving of equipment
please tell chemical dosing pump preventive maintenance check list
It is better to raise change control on arrival of the equipment at the site . URS ,DQ,PS FAT,SAT process can be executed by written Procedures and approved Protocols . This minimize the long holding of change control Open till SAT .
Change related to equipment should be raised before URS.
User requirement specification is the basic document for the equipment to be used for life span of the equipment.
So, whenever if you want to change the requirement, it will directly impact on design qualification and manufacture of the equipment and so on further qualification of the equipment.
So, Ideally it is always advisable to raised the change control for proper tracking and to provide logical justification.
By doing this, Personnel who are involved in preparation and approval part of the URS take serious concern.
Change control should be raised when the equipment is received at site.
Change related to equipment should be ised before URS if more **preferable or scientific justifiable as its new requirement i.e. addition of de- blister machine in primary packaging machine., Addition of quodro Co- mill in granulation area. Because post URS initiation we got sufficeint time to close related task to user department including QMS representative.
Change related to equipment should be raised after equipment is received at site ,when new equipment have not depth risk assessment activity process w/r/t/ system/area/water/air basic requirement. In short easily management with routine production as well as QMS activity.
Usually SAT to be performed with the supplier after equipment is received at the site.
I think it is not justified that before any change control approval how could we goes for a change in the system,process,facility ??? what about risk assessment???
Without prior approval from concerned management authority through cc how we can make decision about GMP changes.
Now suppose if risk evaluation result found out of limit or change is not accepted by the final authority for that particular change, then what about prepared URS,executed DQ,FAT,SAT,PO and finally what to do with site received valuable GMP equipment???