All commercially distributed Drug Products and Over-The Counter (OTC) consumer products that require expiration dating shall be labeled with an Expiration Date that is consumer readable.

This practice outlined in this article should be applicable to all GMP sites where commercially distributed drug products and/or Active Pharmaceutical Ingredients (API) are produced which are required either by their registration or local regulations to have an assigned expiration date.

APIs shall be assigned and labeled with expiration dates only if it is registered or required by local regulation. The expiration date shall be indicated on the Container Label and Certificate of Analysis (COA).

Re-evaluation dating for APIs is outside the scope of this article.

Expiration Dating Periods shall be supported by accelerated and/or real-time stability data. Expiration dates must relate to any storage conditions stated on the label.

Expiration Dates for Drug Products and APIs shall be defined:

• By the month and year that result from adding the approved expiration dating period to the Manufacture Date or to the release date of the Batch/Lot, if the release date is within thirty (30) calendar days of the manufacture date; or
• As defined in the regulatory filing for the product. The expiration date assignment format shall be based on the requirements for the product market.

For APIs, the Expiration Date of the Blended Batch shall be based on the manufacturing date of the oldest tailings or batch in the blend.

For Drug Products Containing reprocessed drug products, the expiration date shall be based on the manufacture date of the oldest reprocessed lot used in the production lot.

Where more than one drug product lot with different Manufacture Dates are packaged together (e.g. 1, 2, 4, 8mg of a product blistered and sealed into one card), the expiration date of the complete package must not exceed that of the product lot with the shortest remaining expiration period used in the package.

Maximum Expiration Dating for drug products shall not exceed five (5) years.

Extension of Expiration Dating for already manufactured and packaged drug product may be performed based on the following criteria:

• Continuous, controlled real-time stability testing program has shown the product to be stable to support the extended expiration dating;
• Concurrent testing of the product shows little drift from the original test data and is within the release Specification; and
• Regulatory approval for the extension has been granted through Product Change Management System.

For Drug Products that require reconstitution, labeling shall include expiration information for both the un reconstituted and reconstituted drug product.

For Drug Products requiring an expiration rate assignment prior to manufacturing the Expiration Date shall be assigned based on a documented planned manufacturing date and approved by the
Quality Assurance.

Prior to packaging the drug product, the assigned expiration date must be verified against the actual manufacture date to be within the acceptable expiry period established by stability studies.

Expiration Date assignments shall be documented and maintained as part of the batch or lot record.
Quality Assurance shall:

• Ensure that the expiration date for each lot is based on a predefined time period commencing on the manufacture date or release date;
• Ensure that the expiration dating period is filed and has regulatory approval;
• Approve the expiration date assigned; and
• Ensure that the product is labeled with the assigned expiration date before the lot is released for commercial distribution.

Changes to expiration date must be processed either through the planned permanent changes, or through one-time temporary changes or Deviations.