Drug storage is one of the pharmacist's most crucial responsibilities. As a result, suitable means for ensuring compliance with these responsibilities must be created and executed.
The pharmaceuticals must be stored in circumstances that avoid contamination and, as far as feasible, degradation. The product's stability remains within the defined limits during its storage and use. Precautions for the effects of the atmosphere, moisture, heat, and light are recommended. One of the most important aspects of patient care is proper pharmaceutical product storage. Manufacturing and storage circumstances can significantly alter the quality of medicinal products.
When it comes to drug deterioration, the two most significant elements are high temperature and relative humidity (RH). A product's or batch of products' final quality and, consequently, their salability can be greatly influenced by variables including temperature, humidity, air quality, time, and aspects of the production process. Refrigeration plants are commonly used for many products that need to be stored in cool environments. These plants must be regularly inspected to guarantee that the proper temperatures are maintained. Stock needs to be kept in environments that are suitable and auditable.
Proper lighting, humidity, ventilation, temperature, and security should be ensured. All pharmaceutical drugs must be stored in accordance with the manufacturer's instructions and the terms of the product authorization. Pharmacy stock should be stored in conditions appropriate to the product's nature and stability.
Special precautions should be taken to prevent contamination, sunlight, UV rays, wetness, air moisture, and extreme temperatures. Medicines should be stored in the original container. Good storage practice is applicable to all instances in which pharmaceutical items are stored during the distribution process.
Pharmaceutical products should be packed in a well closed container that protects the contents from contamination by extraneous solids, liquids or vapors and the loss of the products under normal conditions of handling and storage. The following factors to be taken in consideration for proper storage:
1. Sanitation
2. Temperature
3. Light
4. Moisture
5. Ventilation
6. Segregation
Different pharmaceutical product storage temperature on the basis of stability studies as given below:
Freezer: A freezer maintains a temperature of -25ºC to 10ºC (-13ºF to -14ºF) using a thermostat.
Cold: Cold refers to temperatures below 8ºC (46ºF). A refrigerator regulates its temperature between 2ºC and 8ºC using a thermostat.
Cool: Any temperature from 8 ºC and 15 ºC. Pharmaceutical products that require cool storage can also be stored in a refrigerator, unless otherwise mentioned in the particular monograph.
Good storage practice (GSP) applies in all situations when pharmaceutical items are stored during the distribution process. The WHO guidelines on optimal storage procedures provide additional guidance on the general principles of pharmaceutical product storage.
STORAGE CONDITION ON LABEL
Pharmaceutical items and materials should be stored in accordance with their labeling, which is based on stability testing results. The storage conditions should be determined and indicated on the product label. All medications should be stored under the conditions specified on the label. Humidity, light, and other controls should be in place, as described on the label. Storage areas should be planned or changed to provide optimal storage conditions. The label should mention any unique storage requirements for the product. Written protocols should be available explaining the measures to be done in the case of temperature excursions beyond the labeled storage conditions. All deviations from the designated storage conditions must be thoroughly explored, and the disposition of the stock in question must be evidence-based (such as stability data and technical reasons). Stability testing thus assesses the impact of external influences on the quality of a pharmacological substance or formed product, which is used to forecast shelf life, identify optimal storage settings, and recommend labeling guidelines.