Dear Dr Micheal
Is the manufacturing date considered from the date of dispensing or the date of manufacturing , as MOH inspector ( Egypt ) insist to consider Manuf. date is the dispensing date , we are producing Solid dosage form products , and intend to produce sterile products in the future . is there any reference about this issue
and the second question regarding Expiry date , kindly could you help in Ref. mentioned how expiry date is related to raw material expiry or not related
Thanks and Best Regards
As far as I am aware, globally, all countries consider the manufacturing date as the date that the drug product ingredients are mixed together; on condition that between dispensing (weighing) and usage in formulation, the weighed material is stored under appropriate conditions.
For tablets this is the date of blending/granulation; for liquid products, this is the date that solvent is added to the formulation tank.
Except in India (which has bizarre rules on this), the expiration date of a drug product world-wide has no relationship to the re-test date of the raw materials. Expiration dates for drug products are based on stability studies performed according to ICH guidelines (ICH-Q1 and Q2)
I hope this helps,