Dear All,
Good day to you.
Is there any regulations of extension of shelf life of API & Excipients after retesting. how much extension is allowable after retesting.
please help me with reference.
Thank you in advance.
Also for Excipients shelf life extension, is there any regulation?
ICH Q7 GMP for API, defines: "An API expiry or retest date should be based on an evaluation of data derived from stability studies. Common practice is to use a retest date, not an expiration date (11.61)
thank you.
what about excipients? after retest by users, if results found within specification, is it allowable to extend its shelf life?
The International Pharmaceutical Excipients Council (IPEC) General Glossary, indicates:
regards,
Daysi
Thank you so much for your effective feedback.
Can you please give me the link of this guideline? i searched for it but could not find the required guideline.
Thank you in advnace.