Re process

GOOD MANUFACTURING PRACTICE (cGMP)
1

Dear sir,

 we have some batches(approved) manufactured on jan 2007.that API has 5 years shelf life.For fresh manufacturing date,we want to do the reprocess work. thats acceptable or not.

Thanks and regards
vasu

2

[quote=srinivas2202]Dear sir,

 we have some batches(approved) manufactured on jan 2007.that API has 5 years shelf life.For fresh manufacturing date,we want to do the reprocess work. thats acceptable or not.

Thanks and regards
vasu[/quote]
NO!!! Thats not acceptable, even after reprocessing u will get a fresh Mfg date but Exp date will remain the same. Reprocessing is only recommended when the product parameters are not meeting to the predetermined specifications at any manufacturing step.

3

[quote=srinivas2202]Dear sir,

 we have some batches(approved) manufactured on jan 2007.that API has 5 years shelf life.For fresh manufacturing date,we want to do the reprocess work. thats acceptable or not.

Thanks and regards
vasu[/quote]

No!!! thats not acceptable! Even you can get the fresh Mfg date after reprocessing but Exp date will remain the same. Reprocessing is only recommended when product parameters are not meeting with predetrmined specification at any manufacturing step.

4

Dear sir,

thank you. how can handle the tail end material.

Thanks and Rgds
vasu

5

[quote=srinivas2202]Dear sir,

 we have some batches(approved) manufactured on jan 2007.that API has 5 years shelf life.For fresh manufacturing date,we want to do the reprocess work. thats acceptable or not.

Thanks and regards
vasu[/quote]

Hi Vasu,

In pharmaceutical industry all materials should be given fixed shelf life to use, in your case If you wish to do reprocess to increase physical appearance of your old manufactured product you can goahead, but you should to meet all predetermined relaese specification.
Shelf life of your product cant be change and till now no provision go beyond claim vendor claimed shelf life.

Thanks,
D.Raghavendra.