Can any one guide sampling comes under which deparment???
According to cGMP guidelines it comes under QC but most of the people says sampling is done by QA… any one have the refrence???
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I don’t think QA is mandatory during RM and PM sampling. It can independently done by QC department. But it also depends on company’s system.
Acc. to EU GMP Guide (Chapter 2 in connection with Chapter 6) sampling is clearly the responsibility of
QC
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RM & PM sampling is the responsibility of QC department.
QA dept. is generally involves in Bulk product (In-process) & finish product sampling.
Sampling done by Qc in presence of Qa because after sampling material store in under test area as Qa norm.
Rm and pm Sampling activity is the responsibility of qc
QC shall be responsible for RM & PM sampling & testing .Few organization have IH norn i.e. QA representative must be presence at the time of RM/PM sampling.
However any in process, bulk pack, Semi Finish goods & Finish Good’s sampling is carried out by QA representative.
Thanx all of you for your guidances… it helped alot…
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