WHAT IS GSP? GSP STANDARDS APPLICATION IN PHARMACEUTICAL INDUSTRY
TABLE OF CONTENTS
1. What is GSP and GSP standards and principles in the pharmaceutical industry?
1.1. What is GSP?
1.2. GSP standards and principles in the pharmaceutical industry
2. What is GSP warehouse, GSP standard drug store?
2.1. What is GSP Warehouse? Hospital drug warehouse meets GSP standards?
2.2. Standards on warehouse construction design according to GSP
2.3. Conditions for storing drugs in GSP warehouses
3. Certificate of GSP
1. What is GSP and GSP standards and principles in the pharmaceutical industry?
1.1. What is GSP?
According 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 GSP? 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 adjusted to meet specific specific requirements, while still ensuring the drug is of the intended quality. According to decision No. 2701/2201/QD BYT dated 29 On January 1, 2001, the principles of drug preservation practice were promulgated, the GSP shall be 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. .
Units that need to apply GSP standards:
- Manufacturer, exporter – importer, wholesale distributor and hospital pharmacy.
- The focal point for drug preservation of the national health program and the people’s armed forces; vaccine storage facilities in the national expanded vaccination program at the central, regional, provincial and district levels.
- Drug storage warehouses of hospitals, medical examination and treatment establishments, and vaccination establishments.
The establishment has the right to import but not to exercise the right to distribute drugs and medicinal ingredients in Vietnam.
Conditions to meet GSP standards
- Storekeepers need thorough professional training
- Warehouse and suitable equipment. The environment ensures adequate storage conditions.
- Ensure storage procedures are checked.
1.2. GSP standards and principles in the pharmaceutical industry
GSP standards in the pharmaceutical industry are a set of principles and standards related to appropriate measures for the preservation and transportation of raw materials and products at all stages of production, preservation, storage, transportation and handling. transport and distribution of drugs to ensure and best maintain the safety and quality of drugs and medicinal ingredients through adequate control during storage.
The GSP standard consists of 7 articles and 115 requirements that can be adapted to include: personnel, premises and equipment, drug storage, import, dispensing, documentation and returned drugs, drug is recalled. However, these requirements can be adjusted to meet different units of application, while still ensuring the drug is of the intended quality.
2. What is GSP warehouse, GSP standard drug store?
2.1. What is GSP Warehouse? Hospital drug warehouse meets GSP standards?
GSP warehouse is a warehouse that fully meets GSP standards as required by the Ministry of Health.
GSP-qualified hospital drugstores are drug stores of hospitals, medical facilities, medical examination and treatment that are required by the Ministry of Health and fully meet GSP standards as required by the Ministry of Health.
GSP-certified hospital drugstores in order to ensure the supply of quality drugs to users require good implementation of all stages related to production, preservation, storage, circulation and distribution of drugs.
2.2. Standards on warehouse construction design according to GSP
Design and construction of GSP warehouse should pay attention to: Location, area, design, construction to meet the requirements of GSP warehouse standards.
- GSP warehouse location: The warehouse must have a definite address with a convenient traffic system for transportation, import and export activities, fire prevention and fighting. The warehouse location must be in a safe and dry place, must have a drainage system, to ensure that drugs and medicinal ingredients avoid the influence of groundwater, heavy rain and floods.
- Regarding GSP warehouse area: The warehouse must have a large enough area, suitable for the scale to arrange areas for the activities of receiving, quarantine, inspection, preservation, packing, discharging, etc. establishments that import or provide preservation services of herbal ingredients and traditional medicines must have a minimum total area of 500m2, and a minimum volume of 1,500m3.
- About the design and construction of GSP warehouse: The warehouse is systematically designed and built to protect drugs and medicinal ingredients from adverse environmental influences such as temperature, humidity, waste, etc. pests and does not affect the quality of drugs and medicinal ingredients.
Must meet the requirements on design, construction of the foundation, ceiling, wall and roof of the warehouse as prescribed.
Warehouse areas must have an appropriate area, volume, enough space and reasonable arrangement to ensure GSP standards.
Especially for the storage of products with the risk of explosion (such as flammable and combustible liquids and solids; compressed gases, etc.) must be designed and built for the preservation of products. Explosive products according to the provisions of law, must be far from other warehouses and away from residential areas. Must be well ventilated and equipped with explosion-proof lights, placed outside the warehouse of electrical switches.
Comply with the principles of preservation, provide a clean air system through the sampling of raw materials.
2.3. Conditions for storing drugs in GSP warehouses
Conditions for storing drugs in GSP warehouses:
- If the product label does not specify it, store it at room temperature.
Storage at normal temperature is to store in a dry environment (75% humidity), at a temperature of 15-30°C. At certain times of the day, the temperature can be above 30°C but not over 32°C and the humidity does not exceed 80%. Must be well ventilated, free from the influence of odors, contaminants and strong light.
With specific storage conditions:
- Storage conditions: “Do not store more than 30 °C” is between 2 °C and 30 °C.
- Storage conditions: “Do not store more than 25 °C” is between 2 °C and 25 °C.
- Storage conditions: “Do not store more than 15 °C” is between 2 °C and 15.
- Storage conditions: “Do not store more than 8 °C” is between 2 °C and 8 °C.
- Storage conditions: “Do not store below 8 °C” is between 8 °C and 25 °C.
- Store medicine in a cool store, the appropriate temperature is about 8-15°C.
- Store drugs in cold storage, the minimum temperature is below 8°C.
- When storing drugs in cold storage, the temperature should not exceed -10°C.
- Store the drug under conditions of “Dry”, “Avoid moisture” which is not more than 75% relative humidity under normal storage conditions; or provided that it is contained in a waterproof packaging to the patient.
- Preservation of drugs under the condition of “Protecting from light” means preserving in packaging to avoid light reaching the patient’s hands.
- It is necessary to have an assessment of temperature and humidity homogeneity, to ensure storage conditions, to ensure uniformity of temperature and humidity, the assessment must comply with the general provisions of the instructions.
- There are enough equipment, racks and shelves for queuing. The distance between the shelves, shelves and the warehouse floor must be wide enough to ensure the cleaning of the warehouse, checking and matching, and loading and unloading goods.
- Racking system must be arranged properly and must be coded to be able to identify according to the arrangement of goods in the warehouse.
- Provide adequate lighting for storage areas so that all operations can be performed correctly and safely. Do not let sunlight shine directly on drugs and medicinal ingredients.
3. Certificate of GSP
3.1. What is a GSP certificate?
The certificate of satisfaction of the principle of “Good storage practice” (GSP) is directly licensed at the Department of Health of the provinces and cities within 30 days after receiving the complete and valid dossier.
Periodic time to evaluate the maintenance of GSP compliance at the storage facility is 03 years from the date of signing the audit report of the previous audit (excluding unexpected audits, inspections, and tests). of the Ministry of Health, Department of Health).3.2. Dossier for initial licensing and GSP re-licensing The complete application for initial licensing with a GSP certificate includes:
- Registration form for the inspection of “Good storage practice for medicines” (according to the form).
- Copy of establishment license or business registration certificate or investment certificate, signed by the establishment owner and stamped for certification by the establishment.
- Documents, programs and summary reports on training and training on “Good storage practice for drugs” at the establishment.
- Organization chart of the facility.
- Map of the geographical location and design of the warehouse.
- List of facility’s preservation equipment.
- List of preserved objects and corresponding storage conditions.
A complete dossier for GSP re-licensing includes:
- Registration for re-inspection “Good laboratory practice for drugs”.
- Copy of establishment license or business registration certificate or investment certificate, signed by the establishment owner and stamped for certification by the establishment.
- Report to fix the deficiencies in the previous inspection.
- Report on the changes of the establishment during the 03 years of implementation of “Good laboratory practice” and related documents, if any.
Achieving GSP standards is extremely important for manufacturers, suppliers and directly hospital warehouses, in which GSP-certified drug warehouses are an important factor to ensure the quality of pharmaceutical products. .