A pharmaceutical product must be of the best quality and must meet both good manufacturing and storage practices. Join us to learn about this article’s GSP standard – good storage practice.
What is GSP?
GSP (Good Storage Practice) is the standard of good storage practice for medicines. The purpose of GSP is to ensure the quality of pharmaceutical products in the hands of consumers. The GSP standard sets out measures to ensure the quality of pharmaceutical products.
Subjects of application of the GSP standard
According to Decision No. 2701/2201/QD BYT dated January 29, 2001, promulgating principles of drug preservation practice, GSP is applied to factories that manufacture, export, import, trade, and store drugs.
Conditions to meet GSP standards
To obtain a GSP certificate, the establishment must meet all requirements, including personnel, warehouse, drug storage measures, receiving and dispensing, and finally, a treatment plan for returned goods again.
All staff must be trained and understand good storage practices, including regulations, procedures, and safety.
All employees must ensure hygiene compliance.
Employees working in warehouses must wear appropriate protective gear or clothing.
Storekeepers must be regularly trained to update new state regulations on drug preservation and management and scientific and technical advances applied in drug preservation.
- At the storage area, precautions must be taken to prevent unauthorized persons from entering the storage area.
- Storage areas must have adequate capacity for materials, including incoming materials, packaging materials, intermediate products, finished products, quarantined and released products, rejected products, and return or withdrawal.
- Storage areas should be designed or adjusted to ensure good storage conditions.
- Pharmaceutical materials and products should be stored on the floor and spaced appropriately for cleaning and inspection.
- The storage area must be clean and free of accumulated waste and insects. Appropriate procedures should be in place to clean up any spillage to ensure the complete removal of any risk of contamination.
- Highly active and radioactive materials, narcotics, and toxic, sensitive substances, must be stored in a dedicated area.
- Storage areas must provide adequate lighting to allow all operations to be carried out correctly and safely.
Drug storage warehouses must be at an average temperature of 15-25 degrees Celsius. Drug storage must be odorless, avoid direct sunlight and have a maximum air humidity of 70%.
- If the medicine is stored in cold storage, the minimum temperature is below 8 degrees Celsius.
- The temperature should not exceed -10 degrees Celsius when storing drugs in a frozen warehouse.
- When storing medicine in a cool store, the appropriate temperature is about 8-15 degrees Celsius.
Drug storage is the safe storage of drugs, and their packaging, including the introduction and maintenance of adequate systems of appropriate documentation, including receipts and release slips.
Written instructions and records are required to document all activities in storage areas, including handling expired goods.
Records should be kept for each delivery. Drug records must include quality, quantity, supplier, supplier’s batch number, date of receipt, the batch number assigned, and shelf life.
Label and container requirements of the GSP standard
All raw materials and pharmaceutical products must be stored in containers that do not affect the quality of the materials or products involved.
All containers should be clearly labeled with at least the name of the material, batch number, expiration or retest date, and storage conditions. Abbreviations or confusing symbols may not be used.
Containers and containers must be carefully checked for contamination, tampering, and damage. Any suspicious containers or containers must be isolated for investigation.
Receiving and dispensing drugs
Upon receipt, each container of pharmaceutical products needs to be identified. For example, by label description, batch number, type of ingredient or drug, and quantity.
Medicines and raw materials need to be rotated so that the batches received first or with the expiry date will be used first. The principle of first in – first out (FIFO) or first expiration – first out (FEFO) must be implemented.
Measures should ensure that discarded materials and pharmaceutical products are not reused. They should be stored separately from other materials.
Returned drugs, including recalled products, should be handled according to approved procedures, and records should be kept.
All drugs released from the warehouse and returned must be stored in a quarantine area. Medications are only used when the quality assurance department assesses that the medicine meets quality standards and is safe for users. If the drug is not at good quality, it cannot be used.