028 3916 6552According to the regulations of the Ministry of Health in the drug manufacturing industry, besides complying with GMP standards, manufacturers also need to comply with GSP standards. So what is the GSP Standard applied in the Pharmacy industry ?
What is GSP standard applied in Pharmaceutical industry?
GSP (Good Storage Practice) is understood as the standard of good storage practice for medicines. These standards cover appropriate measures for the storage and transportation of raw materials and products at all stages of production, storage, storage, transportation and distribution of drugs to ensure the safety of ingredients. quality medicinal products to consumers.
GSP provides basic principles, guidelines on good storage practice with 7 articles and 115 requirements. However, these principles and guidelines can be tailored to meet specific specific requirements, while still ensuring the medicinal product is of the intended quality.
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. . Drug storage is the safe storage of drugs, their packaging, including the introduction and maintenance of adequate systems of appropriate documentation, including receipts and release slips. .
Conditions to meet GSP standards
– Storekeepers need to be trained thoroughly
The key staff of the warehouse, the storekeeper needs to have knowledge about the pharmaceutical industry, about preservation operations, preservation methods and management and monitoring of import and export management books and drug quality. Storekeepers must be regularly trained to update new state regulations on drug preservation and management, methods and scientific and technical advances applied in drug preservation.
– Warehouse and equipment
Good drug storage requires proper preparation and use of equipment. Suitable equipment such as: air conditioning system, temperature measuring thermometer, hygrometer to measure humidity in the warehouse…
Storage warehouses need to install explosion-proof lights. The electrical switch system must be located outside.
For drugs stored in warehouses with requirements on temperature and light, they need to be monitored, maintained and adjusted when necessary.
The construction and design of the drug storage area should be appropriate and follow the principles of storage. According to the World Health Organization, a place to store drugs should meet the following conditions:
Storage at normal temperature is in dry, airy weather, temperature ranges from 15-25 degrees Celsius, no smell and other things, avoid direct sunlight, maximum air humidity is 70%.
+ If the drug is stored in cold storage, the minimum temperature is below 8 degrees Celsius
+ When storing drugs in cold storage, the temperature should not exceed -10 degrees Celsius
+ Store medicine in a cool warehouse, the appropriate temperature is about 8-15 degrees
– Preservation procedures
Medicines and raw materials should be stored in conditions that ensure their quality. 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 – First In / First Out) or first expiration – first out (FEFO – First Expired / First Out) needs to be implemented.
Depending on the nature and storage conditions of the product, a program of periodic or irregular inspection and evaluation must be specified to determine product quality. There must be a system of books and standard operating procedures to ensure the preservation, control and monitoring of the export, import and quality of drugs.
– Returned medicine
All drugs that have been released from the warehouse and returned must be stored in a quarantine area. These drugs may only be returned to the drug warehouse for circulation, distribution and use after the quality assurance department evaluates that the drugs meet quality standards and ensure safety for users. If the drug is not of good quality, it cannot be used.
When transporting goods by consignment, the distribution and loading of goods on the means of transport can only be done after a written release order is issued. For special drugs, poisons… it is necessary to maintain the necessary conditions and comply with regulations.
With this article, we hope that you will gain new knowledge about Pharmacy industry as well as understand more about GSP criteria commonly applied to the industry. If you want to learn more about Pharmacy as well as information related to this particular discipline, you can find more related articles.