Decision No. 2701/2001/QD-BYT on the implementation of good storage practice principles for drugs

Pursuant to …;

Regarding the implementation and application of the principle of good storage practices for drugs.of

______________________

THE MINISTER OF HEALTH

Pursuant to the Law on People's Health Protection dated July 11, 1989 and the Drug Regulations issued together with Decree No. 23/HĐBT dated January 24, 1991 of the Council of Ministers (now the Government);

Pursuant to the Ordinance on Product Quality dated December 24, 1999;

Pursuant to Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 86/CP dated December 8, 1995 of the Government stipulating the division of responsibilities for state management of product quality;

Pursuant to Decision No. 108/2002/QĐ-TTg dated August 15, 2002 of the Prime Minister approving the "Strategy for the Development of the Pharmaceutical Industry to 2010";

Pursuant to …;

Article 1. Implement and apply the principle of "Good Storage Practices for Drugs" issued together with this Decision at all units involved in production, business, import-export, sale, storage, drug warehouse service operation, hospital pharmacy departments, research institutes, and health centers.

Article 2. This Decision shall take effect fifteen days from the date of signature and issuance.

Article 3. The Director of the Vietnam National Medicines Administration shall be responsible for guiding, inspecting, and monitoring the implementation and application of the principle of "Good Storage Practices for Drugs."

Article 4. Gentlemen and Ladies: Head of the Office, Inspector General of the Ministry of Health, Director of the Vietnam National Medicines Administration, Heads of subordinate units under the Ministry, Directors of Provincial Health Departments, and Heads of Health Services in sectors are responsible for enforcing this Decision.

PRINCIPLES

"GOOD STORAGE PRACTICES FOR DRUGS"
(Issued together with Decision No.: 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health)

Part I

PART I: GENERAL PROVISIONS

1. Purpose.

To ensure that drugs of quality reach users, it is necessary to properly implement all stages related to production, storage, inventory, circulation, and distribution of drugs.

Good Storage Practices for Drugs (GSP in English) are special measures appropriate for the storage and transportation of raw materials and products throughout the production, storage, inventory, transportation, and distribution stages to ensure that drugs meet their defined quality when reaching consumers.

This document sets out basic principles and general guidelines for "Good Storage Practices for Drugs." However, these principles and guidelines may be adjusted to meet specific requirements while still ensuring the defined quality of drugs.

The principles of "Good Storage Practices for Drugs" apply to manufacturers, exporters, importers, sellers, storers of drugs, hospital pharmacy departments, research institutes, and health centers.

2. Explanation of terms

The terms used in this principle document are understood as follows:

2.1 Drug storage: is the safe keeping of drugs and raw materials, including the establishment and maintenance of complete and appropriate record-keeping systems, including receipts and dispatch notes.

2.2 Drug: is a product derived from animals, plants, minerals, chemical substances, or biological sources, prepared for human use to:

- Prevent and treat diseases.

- Restore or adjust bodily functions.

- Alleviate symptoms.

- Diagnose diseases.

- Improve or enhance health.

- Anesthetize a part or the whole body.

- Affect reproductive processes.

- Alter body shape.

2.3 Raw material: is a substance with or without activity, which may or may not undergo changes, used in the production of drugs. It includes active ingredients, excipients, reagents, solvents, intermediate products, packaging materials, and labels.

2.4 Active ingredient: is a substance or mixture of substances with pharmacological activity used in the production of drugs.

2.5 Excipient: is a substance other than the active ingredient, fully evaluated for safety and included in the drug formulation.

2.6 Packaging material: is any material used in the packaging of the product, excluding containers used to transport the product by various means of transport without unloading before delivery.

2.7 Semi-finished product: is raw material that has undergone partial processing and must undergo further processing before becoming a finished product.

2.8 Finished product: is a drug that has gone through all stages of production, including packaging.

2.9 Recheck date: is the date when drugs or raw materials need to be rechecked and evaluated to determine if they meet the specified quality standards.

2.10 Label: is printed, drawn, or imprinted information directly on the commercial package or firmly affixed to the commercial package of the drug, providing essential information about the drug to assist users in selecting and using it correctly, and serving as a basis for competent authorities to conduct inspections, supervision, and management.

Labels include all labels and printed, written, or illustrated parts on intermediate packaging of the product or on the container holding the product, excluding transport containers.

2.11 Quarantine: is the condition where drugs or raw materials are kept separately in a segregated area or by administrative measures pending decisions on disposal, approval for warehousing, or for compounding, repackaging, or distribution.

2.12 FIFO: is an acronym for "First In/First Out," meaning "first in-first out."

FEFO is an acronym for "First Expired/First Out," meaning "first expired-first out."

2.13 Contamination: is the unwanted appearance of chemical or microbial impurities or foreign objects in raw materials, semi-finished products, or finished drug products during production, sampling, packaging, re-packaging, storage, and transportation.

2.14 Cross-contamination: is the contamination of raw materials, intermediate products, or finished drug products with other raw materials or drugs during production, storage, and transportation.

Part II

GOOD STORAGE PRACTICES FOR DRUGS

1. Personnel:

1.1. According to the scale of the unit, the drug warehouse must have sufficient staff with appropriate qualifications to work in the warehouse area. All staff must be regularly trained in "Good Storage Practices for Drugs," professional skills, and their responsibilities and duties must be clearly defined in writing.

1.2. Key personnel of the warehouse who supervise and inspect must be honest, possess the necessary knowledge and experience, and have the appropriate professional and technical qualifications to fulfill their assigned tasks, meeting state regulations.

1.3. The warehouse manager must be a person with the necessary knowledge and understanding of pharmaceuticals and warehousing procedures: methods of storage, record-keeping for inventory tracking, quality of drugs...

1.4. The warehouse manager must have a minimum qualification of a pharmacy technician for manufacturing and wholesale establishments dealing with modern pharmaceuticals. For manufacturing and wholesale establishments dealing with traditional medicine and medicinal herbs, the warehouse manager must have a minimum qualification of a licensed pharmacist or a pharmacy technician.

1.5. The warehouse manager for toxic drugs, addictive drugs, and psychotropic drugs must comply with all relevant legal regulations.

1.6. The warehouse manager must regularly undergo training to update on new state regulations regarding drug storage and management, as well as advancements in scientific and technical methods applied in drug storage.

2. Warehouse and equipment:

The warehouse must be designed, constructed, equipped, repaired, and maintained systematically to protect drugs and raw materials from adverse influences such as temperature and humidity changes, waste and odors, animals, insects, and pests, ensuring that the drugs maintain their predetermined quality.

2.1 Location:

The warehouse must be built in a dry, safe location with a drainage system to ensure protection against underground water, heavy rain, and floods.

The warehouse must have a specific address located conveniently for entry and exit, transportation, and security.

2.2 Design and Construction:

a- The warehouse must be spacious enough, and when necessary, there should be separation between areas to ensure isolated storage of different types of drugs and batches as required.

b- Depending on the purpose and scale of the warehouse (manufacturer's warehouse, distributor's warehouse, hospital pharmacy department's warehouse...), specific areas must be established, arranged reasonably, and equipped appropriately:

+ Receiving, separate storage, and drug storage area before entering the warehouse.

+ Sampling area for drugs and raw materials: this area must be suitably constructed and equipped with a clean air supply system to meet sampling requirements.

+ Drug storage area.

+ Special storage area for drugs and raw materials requiring special storage conditions.

+ Storage area for substandard drugs and raw materials awaiting processing.

+ Storage area for raw materials and finished products awaiting production or distribution.

+ Packaging, individualizing, and labeling area.

+ Packaging material storage area.

+ Raw material pre-storage area.

c. The warehouse must be designed, constructed, and arranged to meet requirements for pathways, emergency exits, fire prevention and firefighting equipment systems.

d- The ceiling, walls, and roof of the warehouse must be designed and constructed to ensure ventilation, air circulation, and durability against weather impacts such as sun, rain, typhoons, and floods.

đ- The warehouse floor must be sufficiently high, flat, smooth, strong, and treated properly to prevent moisture and leakage, ensuring the activities of employees working in the warehouse and the operation of mechanical equipment. The warehouse floor must not have cracks or gaps where dust can accumulate or pests can hide.

2.3 Equipment:

The warehouse must meet the following requirements:

a- Appropriate facilities and equipment: exhaust fans, air conditioning systems, cargo vehicles, forklifts, thermometers, hygrometers... to ensure storage conditions.

b- Adequate lighting to ensure accurate and safe operations within the warehouse.

c- Sufficient shelving and racks to arrange goods. Drugs and raw materials must not be placed directly on the warehouse floor. The distance between shelves and the floor must be wide enough to facilitate warehouse cleaning, inspection, verification, issuance, and handling of goods.

d- Necessary fire prevention and firefighting equipment and guidelines, such as automatic fire alarm systems, sandboxes, water and fire hose systems, fire extinguisher cylinders, automatic fire suppression systems...

đ- Internal rules governing access to the warehouse area and measures to prevent unauthorized entry.

e- Measures to prevent the intrusion and proliferation of insects, pests, rodents...

2.4 Storage Conditions in the Warehouse:

In principle, storage conditions must match those indicated on the drug label. According to World Health Organization regulations, normal storage conditions are dry, ventilated, and at temperatures ranging from 15-25°C, or up to 30°C depending on climate conditions. Direct intense sunlight, external odors, and other signs of contamination must be avoided.⁰If the label does not specify storage conditions, then normal conditions apply. In cases where storage conditions are specified as cool, frozen, etc., the following provisions shall apply:⁰a- Temperature:

Room temperature warehouse: Temperature range 15-25°C, with short-term fluctuations up to 30°C.

Cool warehouse: Temperature range 8-15°C.

Cold warehouse: Temperature not exceeding 8°C.⁰Refrigerator: Temperature range 2-8°C.⁰4. Liquid bull semen

Frozen warehouse: Temperature not exceeding -10°C.⁰4. Liquid bull semen

b- Humidity: "Dry" storage conditions mean relative humidity not exceeding 70%.⁰2.5 Special Storage Requirements for Drugs and Raw Materials:⁰4. Liquid bull semen

a- Special measures must be implemented for storing toxic substances, light-sensitive, temperature-sensitive, humidity-sensitive substances, highly active substances, and hazardous substances, such as liquids, solid explosives, compressed gases, addictive drugs, and similar substances, highly toxic drugs and chemicals, radioactive materials, and medicinal herbs.⁰4. Liquid bull semen

b- Drugs and raw materials requiring special storage conditions must be stored in separate areas that are suitably constructed and equipped to meet the required storage conditions and legal regulations.

c- Liquids, solids, and compressed gases that are flammable and explosive must be stored in warehouses specifically designed and constructed for flammable and explosive products according to legal regulations, far from other warehouses and residential areas. The warehouse must be well-ventilated and equipped with explosion-proof lights. Electrical switches must be located outside the warehouse.

a- Special measures must be implemented for the storage of toxic substances, light-sensitive substances, temperature-sensitive substances, humidity-sensitive substances, highly active substances, and dangerous substances, such as liquids, explosive solids, compressed gases, addictive drugs and similar substances, highly toxic pharmaceuticals and chemicals, radioactive materials, and medicinal herbs.

b- Pharmaceuticals and raw materials requiring special storage conditions must be stored in separate areas that are constructed and equipped appropriately to ensure compliance with required storage conditions and legal regulations.

c- Liquids, solid explosives, compressed gases... must be stored in warehouses designed and built suitably for storing explosive products according to legal provisions, located far from other warehouses and residential areas. The warehouse must be well-ventilated and equipped with explosion-proof lighting. Electrical switches must be placed outside the warehouse.

d- For toxic drugs, narcotic drugs, psychotropic drugs: they must be stored in areas of the warehouse that comply with the relevant regulations.

đ- Essential oils, ammonia, medicinal alcohol, and other chemicals with odors must be stored in sealed packaging in separate areas to prevent their odors from being absorbed by other drugs.

e- For drugs requiring controlled storage conditions regarding temperature, humidity, and light, these conditions must be continuously monitored and maintained.

Equipment used for monitoring storage conditions such as thermometers, hygrometers... must be regularly inspected, calibrated when necessary, and the results of these inspections and calibrations must be recorded and retained.

g- Sampling areas or individual distribution areas for raw materials and products awaiting packaging must be separated from other storage areas and equipped with necessary tools and equipment for work, including air supply and exhaust systems, and measures to prevent contamination and cross-contamination.

h- Appropriate measures must be implemented to prevent contamination, cross-contamination, and to provide safe working conditions for workers.

3. Sanitation:

3.1 Storage areas must be clean, free of accumulated dust and debris, and must not have insects or pests. There must be written regulations specifying the sanitation program, clearly defining the frequency and methods of cleaning the factory and warehouse.

3.2 All warehouse staff and workers in the storage area must undergo regular health checks. Those suffering from respiratory diseases or having open wounds shall not work in areas directly handling drugs (raw materials, finished products...) that are not sealed.

Hand washing facilities and restrooms must be well-ventilated and appropriately located (isolated from areas receiving, storing, and processing drugs).

3.3 Workers in the storage area must wear appropriate personal protective clothing.

4. Storage Procedures:

4.1 General Requirements:

a- Drugs and raw materials must be stored under conditions that ensure their quality. Drugs and raw materials must be rotated so that those received earlier or with an earlier expiration date are used first. The principle of "first-in-first-out" (FIFO) or "first-expired-first-out" (FEFO) must be followed.

b- Drugs awaiting removal must be clearly labeled and segregated to prevent their inclusion in production, circulation, and use.

c- Depending on the nature and storage requirements of the product, a regular or spot-check inspection and evaluation program must be established to determine the product's quality.

d- There must be record-keeping systems and standard operating procedures to ensure the management, control, and monitoring of drug entry, exit, and quality.

19 ||| 4.2 Labels and Packaging:

a- Drugs must be stored in suitable packaging that does not adversely affect their quality while protecting them from environmental influences, and in some cases, this includes anti-bacterial protection.

b- All drug packaging must bear clear, legible labels containing all required information and complying with legal regulations on drug labeling and trademarks. Abbreviated drug names or unauthorized names or codes may not be used.

c- Each type of packaging, label, or product must have separate documentation indicating storage conditions, preventive measures, and expiration dates (if applicable).

d- A separate area must be designated for storing drug labels and printed packaging materials. Specific regulations must be established for the receipt and issuance of these labels and packaging materials.

đ- Compliance with pharmacopoeia requirements and relevant legal regulations concerning labels and packaging must be adhered to.

25 ||| 4.3 Receiving Drugs:

a- Drug receipt must be conducted in a dedicated receiving area, separate from storage areas. This area must have storage conditions to protect drugs from adverse weather effects during unloading and inspection.

b- Drugs must be inspected and compared with related documentation upon entry, verifying the type, quantity, and other information on the label such as name, manufacturer, supplier, batch number, expiration date...

c- Batches must be checked for uniformity, and if necessary, divided into smaller batches according to the supplier's batch numbers.

d- All packaging must be carefully inspected for contamination and damage, and if necessary, cleaned or isolated for further examination. All drugs with damaged packaging, missing seals, or suspected contamination must be segregated for further handling and not mixed with other drugs.

đ- Special storage condition drugs (narcotics, poisons, cold-stored drugs...) must be quickly inspected, classified, and stored according to instructions on the label and legal regulations.

e- Records for each incoming shipment and batch must be kept and stored. These records must include the drug name, form, concentration, quality, quantity, production batch number, expiration date, receipt time, and code (if applicable). Legal regulations on record retention must be followed.

g- Drug sampling for quality testing must be conducted in a designated sampling area by qualified personnel, following the drug sampling regulation for quality determination.

Sampled batches of drugs and raw materials must be separately stored. Drug batches must remain segregated during storage and subsequent storage periods.

h- Segregation procedures must be carried out either through the use of separate storage areas or electronic data processing systems.

Measures applied must be sufficiently secure to prevent the use or distribution of drugs or raw materials that have not been controlled, tested, or meet regulatory requirements.

The measures applied must be sufficiently safe to prevent the use or distribution of uncontrolled, untested, or non-compliant pharmaceuticals and raw materials.

i- Medicines and raw materials must be stored in a separate system until there is a document accepting or rejecting them from the quality control room. Security measures must be implemented to ensure that rejected medicines and raw materials will not be used. While awaiting decisions on destruction, reprocessing, or returning to suppliers, these medicines and raw materials must be kept separately from other medicines and raw materials.

4.4 Issuing - Inventory Rotation.

a- Only medicines and raw materials meeting quality standards and still within their shelf life may be issued. Medicines and raw materials with damaged packaging or suspected quality issues shall not be issued or distributed.

b- There must be and retain records (outgoing and incoming medicine tracking forms, quality monitoring forms, etc.) showing all entries and exits of medicines and raw materials corresponding to production batches.

c- The issuance must follow inventory rotation principles (first-in-first-out or near-expiration-first-out), especially for medicines and raw materials with expiration dates. Note that if a type of medicine or raw material with a shorter shelf life is received later than those of the same type with longer shelf lives, the former must be issued first.

d- Partially used boxes or bags of medicines and raw materials must be securely sealed to prevent spillage or cross-contamination during storage.

e- Boxes or bags of medicines and raw materials that are damaged, unsealed, missing labels, or have torn and unclear labels shall not be sold or issued and must immediately report to the quality control department.

4.5 Storage of Medicines.

a- Storage conditions such as packaging types, temperature limits, humidity levels, protection from light... must be maintained throughout the storage period. Special attention must be given to medicines containing active ingredients that are unstable under temperature, humidity, or light conditions (Refer to Appendix - List of Some Unstable Active Ingredients).

b- Medicine packaging must remain intact throughout the storage period. Packaging materials of one type should not be mixed with those of another type.

c- Toxic medicines, addictive medicines, and psychotropic medicines must be stored according to the relevant regulations.

Temperature-sensitive medicines must be stored in cold storage or refrigerators. Temperature checks must be conducted at different locations within the storage area.

Light-sensitive medicines must be stored in opaque packaging in dark rooms.

Volatile medicines and moisture-sensitive medicines must be stored in cold storage with tightly sealed packaging. Strong desiccants must be stored in dry rooms with sealed glass or plastic packaging. If possible, stoppers should be coated with paraffin.

Medicines with odors must be stored in sealed packaging in separate warehouses.

Herbal medicines must be stored in dry, well-ventilated warehouses. Pallets must be arranged to allow air circulation. Suitable packaging materials for herbal medicines can include glass, plastic, paper, etc. Herbal medicines containing essential oils also need to be stored in sealed packaging.

Flammable and explosive substances must be stored in separate warehouses in compliance with legal regulations.

d- Regular stocktaking of medicines in the warehouse must be conducted by comparing current stock and remaining quantities with outgoing and incoming medicine tracking forms. In all cases, stocktaking must be performed when each batch is used up.

đ- All discrepancies and losses must be investigated to identify causes due to mixing, carelessness, or other errors.

e- Regularly check batch numbers and expiration dates to ensure the principle of first-in-first-out or near-expiration-first-out is followed, and to detect nearing or expired products.

g- Regularly inspect the quality of stored goods to detect changes and damage caused by storage conditions such as temperature, humidity, or other factors that may affect the quality of medicines and raw materials.

h- Medicines and raw materials that do not meet quality standards or have expired must be stored in a separate area, labeled, and marked as pending processing. Measures must be taken to prevent the issuance and use of expired medicines and raw materials that do not meet quality standards.

i- Appropriate transportation and storage equipment must be provided to ensure medicines and raw materials are protected from breakage and damage due to weather conditions exceeding specified limits such as extreme heat, humidity, etc., during transportation and storage. Special attention must be paid to medicines and raw materials requiring special storage conditions.

5. Returned Medicines.

5.1 All medicines returned from the warehouse must be stored in a separate area. These medicines can only be reintroduced into the warehouse for circulation, distribution, and use after the quality assurance department evaluates and confirms they meet quality standards and are safe for users.

5.2 All returned medicines that are evaluated by the quality assurance department as not meeting quality standards or being unsafe for users shall not be used and must be processed according to legal regulations.

5.3 Medicines returned by patients must be placed in a separate area awaiting disposal.

6. Dispatch (Transporting Medicines by Dispatch).

6.1 Issuing and loading onto transport vehicles can only be carried out after receiving a written dispatch order.

Principles and regulations for the dispatch process of transporting medicines must be established based on the nature of the medicines and after considering all preventive measures.

6.2 For medicines requiring special storage conditions during transportation, these conditions must be maintained.

6.3 Transportation of toxic medicines, addictive medicines, and psychotropic medicines must comply with relevant regulations.

6.4 Transport packaging must protect medicines from external influences and must be clearly labeled without being easily erased or altered.

6.5 Dispatch shipping documents must clearly state:

- Shipping time.

- Customer name and address.

- Sender's name and address.

- Name and address of the carrier.

- Name of the drug, form, dosage, quantity, and batch number.

- Conditions for transportation and storage.

6.6 All documents related to transportation and shipment must be kept by both the sender and the recipient and stored in a secure location.

7. Documentation.

7.1 Operating procedures: Approved standard operating procedures must be available and displayed in easily readable locations within the warehouse area, detailing the methods of work. These procedures must accurately describe processes for receiving and inspecting incoming drugs, storage, sanitation, and maintenance of inventory and equipment (including pest control procedures), regulations on recording storage conditions and safety of drugs during transportation, drug distribution, records including customer orders, returned drugs, recall procedures, and information tracking... These procedures must be reviewed, signed off, and dated by authorized personnel.

7.2 There must be an appropriate system for recording entries and exits of drugs, including the name of the drug, batch number, expiration date, quantity, quality, supplier, manufacturer... complying with legal requirements. If electronic record-keeping systems are used, they must comply with legal provisions. Specific preventive measures must be established to prevent unauthorized access, use, or modification of stored data.

- Drug entry and exit monitoring sheet (attached model 1-GSP/MB).

- Drug quality monitoring sheet (attached model 2-GSP/MB).

- Other forms as prescribed by relevant Ministries and Departments.

There must be separate monitoring sheets for each type of product and each specification of the product.

For the distribution and receipt of toxic drugs, addictive drugs, and psychotropic drugs, compliance with the documentation requirements set forth in relevant regulations is mandatory.

Part III

IMPLEMENTATION GUIDELINES

1. General Provisions:

1.1 Export-import units, trading units, storage units of drugs, service units providing drug storage, hospital pharmacy departments, research institutes, health centers must develop phased plans for investment and upgrading to build drug warehouses according to the principle of "Good Storage Practices for Drugs".

1.2 Drug manufacturing units must simultaneously implement "Good Manufacturing Practices for Drugs" and "Good Storage Practices for Drugs" during the implementation process.

2. Implementation:

2.1 Training:

a- The Ministry of Health (Vietnam National Medicines Administration) shall organize the dissemination and training on "Good Storage Practices for Drugs" for Vietnam Pharmaceutical Corporation, provincial and municipal health bureaus under the central government, health sectors, production and trading units, central hospitals, and research institutes with beds.

b- Provincial and municipal health bureaus under the central government, Vietnam Pharmaceutical Corporation, and health sectors are responsible for disseminating, training, and educating their subordinate units, including hospital pharmacy departments, research institutes, and health centers within their jurisdiction, on "Good Storage Practices for Drugs".

c- Units shall disseminate and train their employees on "Good Storage Practices for Drugs".

2.2 Registration Procedures and Inspection Authority:

2.2.1 Application for Inspection:

After self-inspection and evaluation, units that meet the standards of "Good Storage Practices for Drugs" shall submit an application for inspection of "Good Storage Practices for Drugs" to the Ministry of Health (Vietnam National Medicines Administration). The application includes:

- An application for inspection of "Good Storage Practices for Drugs" (attached model 3-GSP/MB).

- Program, content, and results of training on "Good Storage Practices for Drugs" at the facility.

- Organizational structure and staffing chart of the facility.

- Layout diagram and design of the warehouse.

- Certificate of environmental compliance from the competent authority.

- List of storage equipment of the facility.

- List of types of items stored in the warehouse.

- Self-inspection report on "Good Storage Practices for Drugs".

The application must be made in three copies and submitted to the Vietnam National Medicines Administration.

2.2.2 Application for Re-inspection:

The application for re-inspection includes:

- A re-inspection application for "Good Storage Practices for Drugs".

- Report on changes in staffing, organization, and facilities of the unit over the past two years of implementing "Good Storage Practices for Drugs".

- Summary report on the program, content, and results of training on "Good Storage Practices for Drugs" at the unit over the past two years.

- Self-inspection report and assessment of the unit's implementation of "Good Storage Practices for Drugs" in the most recent period.

2.2.3 Inspection Authority and Issuance of Certification:

The Vietnam National Medicines Administration is responsible for receiving, reviewing applications for inspection, forming inspection teams, and issuing certificates to units that meet the standards of "Good Storage Practices for Drugs".

2.2.3.1 Standards for Inspectors of Good Storage Practices for Drugs:

- Hold a bachelor's degree or higher, with experience in pharmaceutical management in general and drug storage in particular.

- Be honest and impartial.

- Have scientific working methods, strictly adhere to regulations and rules, have the ability to quickly identify deficiencies in the unit, and propose convincing measures to help the unit overcome shortcomings.

2.2.3.2 Review of Applications for Inspection of Good Storage Practices for Drugs:

After receiving complete applications for inspection of "Good Storage Practices for Drugs" from the unit as stipulated (sections 2.2.1 and 2.2.2), the Vietnam National Medicines Administration will collaborate with experts from relevant agencies to review the application (with a review record). Within thirty days from the date of receiving complete valid applications, the Vietnam National Medicines Administration will issue a decision to form an inspection team to conduct inspections of "Good Storage Practices for Drugs" at the unit. If the application does not fully meet the requirements, the Vietnam National Medicines Administration must send a letter to the unit explaining the reasons.

2.2.3.3 Inspection and Issuance of Certificates:

- Composition of the inspection team: Vietnam National Medicines Administration and the provincial or municipal health bureau where the enterprise is located.

- Inspection team composition: The Vietnam National Pharmaceutical Administration and the Health Department of the province or centrally-administered city where the enterprise is headquartered.

The inspection report must be signed and confirmed by the head of the facility and the leader of the inspection team, and made into three copies: one copy to be kept at the facility, one copy to be kept at the Vietnam National Pharmaceutical Administration, and one copy to be kept at the Health Department of the province or centrally governed city where the unit is headquartered.

After the inspection, if the facility meets the "Good Storage Practices for Medicines" principles, the Ministry of Health (Vietnam National Pharmaceutical Administration) will issue a certificate of compliance with the "Good Storage Practices for Medicines" standard. The "Good Storage Practices for Medicines" certificate is valid for two years from the date of issuance. Three months before its expiration, the facility must complete the procedures for re-inspection according to the provisions in Section 2.2.2, Point 2.2, Subsection 2, Part III of this principle document. If it meets the specified standards, the facility will be issued a new certificate.

Regular inspections of "Good Storage Practices for Medicines" shall be conducted once every two years, except in cases of extraordinary circumstances requested by the facility or the Ministry of Health (National Pharmaceutical Administration).