Is Process Validated samples required for IND submission ?

S

SGquality

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Need urgent help -

Our customer, a Pharmaceutical company is submitting their IND (Investigational New Drug) and use our containers and closures for Clinical Trials.

Is it true that the level of Process Validation on our containers and closures need not be full fledged as its for IND clinical trials and not to be used for commercial manufacturing ?
 
Statistical Steven

Statistical Steven

Statistician
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Not sure I follow the actual question, so if I miss the point please correct me. You have a customer that uses your containers and closure system. Do THEY need to do a full fledged validation of the system? The answer is no, they don't usually. The IND contains pre-clinical data and proposed Phase I studies. Part of their development will be to show product stability including container closure systems. They will have a "full fledged" PV by PMA time.

If you are asking if YOU need to validate your process of making the containers and closure system, the answer is YES. Your customer should have done an audit before choosing you as a supplier.

Does that help?


SGquality said:
Need urgent help -

Our customer, a Pharmaceutical company is submitting their IND (Investigational New Drug) and use our containers and closures for Clinical Trials.

Is it true that the level of Process Validation on our containers and closures need not be full fledged as its for IND clinical trials and not to be used for commercial manufacturing ?
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