How to assign expiration date in medicinal products
- Kazi
- Last modified: August 1, 2024
Importance of expiration dates
All commercially distributed drug products and over-the-counter (OTC) consumer products requiring expiration dates must be labeled with a consumer-readable format. This practice is essential to ensure consumer safety and compliance with regulatory standards.
This article outlines practices applicable to all GMP sites producing commercially distributed drug products and Active Pharmaceutical Ingredients (API) that require an expiration date to be assigned by registration and local and international regulations.
How do we define expiry dates for drug products?
Expiration dates for drug products and APIs are defined in the following ways:
– Add the approved expiration dating period to the manufacture date or the release date of the Batch/Lot, provided the release date is within thirty (30) calendar days of the manufacture date.
– As defined in the product’s regulatory filing, the format of the expiration date assignment must align with the product’s market requirements.
For APIs, the expiration date of a blended batch is based on the manufacturing date of the oldest batch in the blend. The expiration date for drug products containing reprocessed products is based on the manufacture date of the oldest reprocessed lot used.
Expiration dates for APIs
APIs should be assigned and labeled with expiration dates only if registered or required by local regulations.
The expiration date must be indicated on the container label and the Certificate of Analysis (COA). Re-evaluation dating for APIs is beyond the scope of this article.
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Supporting evidence for expiration dating periods
Comprehensive stability data must support expiration dating periods.
Accelerated stability testing involves storing the product at elevated temperatures and humidity levels to expedite chemical degradation or physical changes.
Real-time stability testing involves storing the product under recommended storage conditions and monitoring its stability over time.
Both (accelerated and real-time) testing methods are crucial as they simulate different storage conditions the product might encounter.
The data from these tests help establish a reliable expiration date, ensuring the product remains safe and effective throughout its shelf life.
Additionally, any specific storage conditions stated on the label must align with the stability data to ensure consistency and accuracy.
Packaging and expiration dates
When packaging multiple drug product lots with different manufacture dates together, the expiration date of the complete package must not exceed that of the product lot with the shortest remaining expiration period.
This approach ensures the integrity and efficacy of the entire package, preventing potential confusion and ensuring patient safety.
Packaging configurations should also be considered to ensure that each unit within the package adheres to the same high standards of quality and expiration dating.
Maximum expiration date for drug products
The maximum expiration date for drug products must not exceed five (5) years.
This limitation ensures that the products remain within their validated stability period. More extended expiration periods may lead to uncertainties about the product’s efficacy and safety.
Therefore, continuous stability testing is essential to justify and support extended expiration dates beyond the typical range.
240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
How do you extend the expiration date?
Extension of the expiration date for already manufactured and packaged drug products may be performed based on the following:
– Continuous, controlled, real-time stability testing program showing product stability. This program involves regular testing intervals throughout the product’s shelf life to ensure ongoing compliance with stability parameters.
– Concurrent testing showing minimal drift from original test data and compliance with release specifications. This involves comparing new test data with initial data to detect significant changes.
– Regulatory approval for the extension granted through the product change management system. This process involves submitting detailed stability data and justifications to regulatory bodies for review and approval.
Labeling for reconstituted drug products
Drug products requiring reconstitution must include expiration information for the label’s unreconstituted and reconstituted states.
This dual labeling ensures that healthcare professionals and patients know the product’s stability timeline in both forms.
The label should clearly state the time frame within which the reconstituted product must be used, based on stability data, to ensure its efficacy and safety.
Assigning expiration dates before manufacturing
Expiration dates for drug products requiring an assignment before manufacturing must be based on a documented planned manufacturing date and approved by Quality Assurance.
Before packaging, the assigned expiration date must be verified against the actual manufacture date to ensure it falls within the acceptable expiry period established by stability studies.
240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
Documentation and quality assurance
Expiration date assignments must be documented and maintained as part of the batch or lot record.
Quality Assurance must ensure the following:
– Expiration dates for each lot are based on a predefined period commencing on the manufacture or release date.
– Expiration dating periods are filed and have regulatory approval.
– Assigned expiration dates are approved.
– Products are labeled with the assigned expiration dates before lot release for commercial distribution.
Managing changes to expiration dates
Changes to expiration dates must be processed through planned permanent changes, one-time temporary changes, or deviations.
Planned permanent changes involve updating the expiration date based on new stability data and obtaining regulatory approval.
One-time temporary changes may be necessary for specific batches under exceptional circumstances and must be justified and documented.
Deviations occur when unexpected issues arise; a temporary change is needed to address them.
Conclusion
Adhering to these guidelines for assigning expiration dates ensures the safety, efficacy, and quality of drug products and APIs throughout their shelf life.
Properly assigned and labeled expiration dates, supported by robust stability data and regulated packaging practices, are key to maintaining product integrity and patient safety.
Proper documentation and quality assurance for expiration dates support the regulatory requirements, ensuring consumers receive reliable and effective products.
Author: Kazi Hasan
Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation.
Kazi has worked with several global pharmaceutical companies to streamline production processes, ensure product quality, and validate operations complying with international regulatory standards and best practices.
Kazi holds several pharmaceutical industry certifications including post-graduate degrees in Engineering Management and Business Administration.
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