- OBJECTIVE :
- To lay down the procedure to assign expiry date to a finished product.
- RESPONSIBILITY :
- Officer Production/Officer Quality Assurance
- Head – Quality Assurance to ensure compliance.
- PROCEDURE
- Manufacturing date :
- The date of manufacture of the batch shall be the date on which an active ingredient has been added to a batch.
- Expiry date :
- A tentative expiry dating period of upto 24 months will be assigned to all solid dosage forms, if the drug has retained 90% of its original potency after 90 days storage at 40°C ± 2°C/75% ± 5%RH. The same shall be confirmed by long term stability studies.
- The expiry date of a drug product should not exceed the expiry date of the drug substance.
- The expiry date for a batch of finished product shall be calculated from date of manufacture of product.
- For e.g., If the date of manufacture of a drug product is 5 Dec ‘2016, and the drug product has a shelf life of 2 years, then the date of expiry shall be Nov ‘2018.
- Similarly if date of manufacture of a drug product is 31st Dec ‘2016 and drug product has a shelf life of 2 years, then the date of expiry shall be Nov ‘2018.
- To assign expiry date to a finished product containing more than one active ingredient, assign the earliest expiry date of either of the active ingredient based on the expiry date of each of the raw materials allotted by the manufacturer.
- For e.g., In a combination formulation of A, B, and C, the expiry date assigned is Dec 17 based on individual expiry dates of A (Dec 17), B (Dec ’18 ), and C (Oct ’19).
- The date of expiry for the finished product will include only the month and year, and it is expected that the product will meet specifications through the last day of that month. The month will be specified in numerical like 15, 16, 17, and 18 respectively, whereas year will be specified in numerical as 2015, 2016, 2017, 2018, etc.,
- If the production lot/batch contains reprocessed material, the expiry date period shall be computed from the date of manufacture of the oldest reprocessed lot.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision – 00 New SOP
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