Dear All,
Anybody tell me difference between Validation & Qualification.
Regrds
himanshu
Dear Himanshu,
Qualification is a sub part of validation.
A.Validation is documented evidence that provides a high degree of assurance that a specific process should consistently meet its pre-determined specifications and quality attributes. Validation applies to processes (for example, process validation, cleaning process validation and computer validation).
B. Qualification is a subset of validation and is documented evidence that provides confidence that equipment, instruments, facilities, software or utility systems have been selected, designed, installed, constructed and/or operated as intended and meet pre-determined acceptance criteria and relevant specifications. Examples of qualification are installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
For instance: Autoclave system is qualify, IQ, OQ and PQ , but their sterilization cycle is develop and validated.
C. Software verification: Examination of a software system or component to ensure it satisfies requirements that must have been implemented in it or Software verification is a broad and complex discipline of software engineering whose goal is to assure that a software fully satisfies all the expected requirements. .
Conclusion:
Equipments are qualified and their process are validated.
Hi Shahnawaz
I always seem to mix this up to be honest.
Shahnawaz you have said that you need an IQ, OQ, PQ in order to qualify an autoclave but an IQ, OQ, PQ is required in order to complete the validation lifecycle.
Qualification Vs Validation any more thoughts of what is the definite answer
Dear Graham O’Keeffe,
Qualification is a sub set of validation, so qualification n validation are linked together, like another confusion thing difference in calibration & verification.
In simple words, Equipment, instruments & system qualify and process is validated, firstly the equipment, instrument, area or system qualify then their process validated. for instance blender, FBD, compression machine, cartonner are qualified and the specific product process validated on these qualified equipment and qualified utilties.
I think this may clear the confussion,
Thanks and best regards,
[quote=gokeeffe]Hi Shahnawaz
dear
pls advice me on the same.
what r the parameters
Steps to be incorporated during PQ of Bulk Packing Line CVC
Regards
prasad
pvalidation@nicholaspiramal.co.in
@Pvalidation
Dear can u define the functions of this “bulk packing line CVC”, generally Performance Qualification addresses the Functional Requirement Specifications (FRS) of the equipment so u can better understand what to select as study design for PQ!!!
Regards,
Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC, Ethiopia
Kindly let me know the equipmemt details and scope.
dear Himanshu
Qualification is a part of validation.
valiation is a broader term where qualification is for equipment about thier designing,installation,operation and performance.
in short, validation is for that process in which that equipment is used and qualifiocations are the equipment specifications.