Nearer expiry date R.M

(Ravi) #1

If a product (for e.g. ABC) is being manufactured, on dated 29 Nov. 2018 and in this product formulation if one of the R.M. is having expiry date Nov. 2018 (RM Mfg. date Dec. 2016, Exp. date Nov. 2018), then in this condition can i use this R.M. without any testing.
what is the actual guideline for using RM that is reached nearest expiry date or having last day of expiry.

(Sajjad Ahmad) #2

it can be used before expiry without testing.

(Ankur Sukhija) #3

Yes, that RM can be used even as such without any testing if its an excipient. But for the safer side of the patient and the product as well , it Must undergo testing to identity that no impurities are generated into it.Although its an inert material , so it won’t be observed with any effect on product quality.
Also please confirm either that RM labelled was the expiry date or best before date . If it is best before then retesting would be also an option


If excipient can be used.

Near Exipiry Active material can not used as per Schedule M

(Ahmed Adel Ibrahim) #5

please send Schedule M

(Sajjad Ahmad) #6

Schedule M is having the details about company premises, quality control system, quality control laboratories, GMP in production, cleaning of equipments, housekeeping, cross-contamination and other related topics.