Question No:1
A working standard is qualified against USP Reference standard. Now few changes are made in the manufacturing process. should i requalify the working standard in this case.
If i requalify the it, the potency which we require from the std would not take any effect of the change.
Question No:2
One new test is added to the specification and STP(Std test procedure) is revised . now should i requalify the working standard as per the new STP.
If it is requalified, the potency which we require from the std would not take any effect of the change.
Please discuss and provide relative guidance from any reference guidelines.
Regards,
Bujji Kanchi.
Please attached/share also reference SOP on how to qualify working standard.
Question 1 :
A) If the changes made to the manufacturing process of a production batch, you are not required to do any qualification or re-qualification so on…
B) Changes in the manufacturing process of a working standard requires to complete qualification of your working standard against the pharmacopoeal standard. What i mean to say is you need to show that, the new manufacturing process of working standard does not effect the characteristics of your working standard[potency or whatever].
Question 2 :
Verify the included test in the STP with current working standard. If it pass no need to do the re-qualification.
Guidance : I do not find any guidance with reference to re-qualification of pharmacopeial standards.