Expiry date of the pharmaceutical products
Shelf Life of the pharmaceutical product shall be assigned in accordance with the approved and registered condition in the specific country or region.
The stability study of drug is done before the scale-up batches that are at the research and development stage at R&D. According to the stability data, the expiry date is decided.
Region or country-specific requirements it is always there in batch manufacturing record.
The expiry date of the pharmaceutical product depends on storage temperature and humidity.
Temperature and humidity vary from country to country.
Four climatic conditions zones defined by the international conference on harmonization ICH:
- Climatic zone 1: Also called a temperate zone. These covers country’s like Russia, Canada, UK etc.
Temperatures of this zone are around 21°c and humidity of this zone is around 60%.
- Climatic zone 2: Also called a subtropical region.
This region covers countries japan, USA.
The temperature of this region is 26°c and the humidity is 65%.
- Climatic zone 3: also called a tropical dry zone.
This region covers countries like Australia Argentina.
The temperature of this zone is 31°c and humidity of this region is 60%.
- Climatic zone 4: also called a tropical wet zone. This zone covers countries like India Indonesia, brazil.
The temperature of this zone is 31°c and humidity of this region is 70%.
For the deciding of expiry of the pharmaceutical product, we use to check long term stability data, intermediate stability data, and accelerated stability dada.
For general pharmaceutical product :
1.long term stability study: it is for the 12 months either for temperature 25°c and at 60% relative humidity or for 30°c and at 65% relative humidity.
- Intermediate stability study: it is for the 6 months. With the condition of temperature 30°c and 65% relative humidity.
- Accelerated stability study: It is for the 6 months with the condition of temperature 40°c and 75% relative humidity.
For those stored in the refrigerator:
1.long term stability study: it is for 12 months at temperature 5°c.
- Intermediate stability study: it is for 6 months at temperature 25°c and at 60% relative humidity.
For those stored in a freezer: It is for 12 months at temperature -20°c.
If the stability report of the drug is okay for the 24 months then the expiry of the drug is for 24 months.
Expiry of a pharmaceutical product is always less than the expiry of API.