Dear All,
Good day.
please help in following issue.
is there any rules/ regulation that raw materials shelf life to be same as product shelf life?
Suppose Excipient shelf life is April 2024, and finished product shelf life is given April 2025. finished product is manufactured with that excipient. Is there any regulation that excipient should also have shelf life through out finished product.
please help with reference, guideline.
thank you in advance.
Madam it is all about validation study which is to be performed during Pilot batch stability study but thumb rule is that Finished Product (FP) expiry is finalized based on expiry of active and excipients. Sort expiry active or excipients can not be used in FP if it is used then FP expiry must be same as expiry of active and excipients.
According to the Indian Drugs and Cosmetics Act 1940 and the rules thereunder 1947, please note the following,
SCHEDULE M
GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS
10 Raw Materials, (point # 10.9)
Therefore it is to be ensured that the formulation product’s shelf-life shall not exceed that of active raw materials used in that formulation.
thank you Sir for your valuable information.
