Decisions about the deployment of application of principles of good practice for preservation of smoking _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ MINISTER of health pursuant to the law on people's health protection 11/7/1989 and the Charter smoking prevention, healing attached to Decree No. 23 dated January 24, 1991 of the Council of Ministers (Government);
The base quality of goods Ordinance on 24/12/1999;
Pursuant to Decree No. 68/CP dated 11/10/1993 of specified government functions, powers and organization of the Ministry of health;
Pursuant to Decree No. 87/CP on 08/12/1995, of the Government assigned state management responsibility for the quality of the goods;
Proposal of the Director General Vietnam Pharmacy Management, Decisions 1. Deploy the application of the principle of "good storage practice" attached to this decision in all the units of production, sales, import and export, trading, stock trading, warehouse storage services, hospital pharmacy, Research Institute and medical center.
Article 2. This decision takes effect 15 days from the date of signing, promulgation.
Article 3. He is Director of the Vietnam pharmaceutical Management Bureau is responsible for guiding, inspecting and monitoring the application of the principle of "good storage practice".
Article 4. The He, she: Chief, Chief Inspector of the Ministry of health, Director of the Vietnam pharmaceutical Management Bureau, heads of subdivisions, Director of the Health Department of the province or city level, heads of health departments responsible for the implementation of this decision.
 

 



KT. Health MINISTER DEPUTY MINISTER (signed) Le Van the PRINCIPLE Infusion "to GOOD STORAGE PRACTICE" (attached to decision No. 2701/2001/QD-BYT on 29/6/2001 of the Minister of health) part I GENERAL PART 1. The purpose.
To ensure the supply of quality drugs to the hands of users requires the implementation of all the stages related to production, preservation, storage, distribution and circulation of drugs.
Good storage practice (English: Good Storage Practices, abbreviation: GSP) is the special measure, suitable for the storage and transport of raw materials, products in all the stages of production, preservation, storage, transport and distribution of drugs to ensure specified quality medications when coming to consumers.
This text determines the basic principles, General guidelines on "good practice to preserve the drugs". However, the guidelines, the guide can be adjusted to meet your specific requirements, but still ensure quality medicines.
The principle of "good practice to preserve the drugs" is applicable to manufacturers, exporters, importers, traders, stock medicines, hospital pharmacy, Research Institute and medical center.
2. Explanation of terms the terms used in the guidelines are interpreted as follows: 2.1 preservation of smoking: is the safe storage of medicines, raw materials, including getting put to use and maintain the full range of document profile system accordingly, including the receipt and voucher.
2.2 Smoking are products derived from animals, plants, minerals, pharmaceutical chemistry or biology are manufactured for use in people, in order to:-prevention, healing.
-Recover, adjust body functions.
-Reduces symptoms of the disease.
-Diagnosis of the disease.
-Restore or improve health.
-Loss of sensation of a full body or parts.
-Compromising the reproductive process.
-Do change your body shape.
2.3 materials are active or not active, have genetically modified or not modified to be used in the production process. Include active substances, excipients, reagents, solvents, intermediate products, packaging and labeling of medications.
2.4 active ingredient is a substance or mixture of substances are studied to be used in the manufacture of drugs.
2.5 excipient is the substance, not the active ingredient, had been a full review of safety and be put on drug distribution system.
2.6 the packaging is all the material used in the packaging of the product, excluding the container used for product packaging, transport by means of different transport without unloading the goods inside before arrival.
2.7 semi-finished material has been processed in part, and to undergo the treatment before become finished products.
2.8 is smoking products have undergone all the stages of the manufacturing process, including packaging stages.
2.9 Days check back as the date on which drugs, raw materials need to be checked, reassess whether quality standards regulations do not.
2.10 label as prints, drawings, photographs, signs are imprinted directly on the famous commercial packaging or tagged, sure on commercial packaging of drugs to show the necessary information and primarily about smoking, help users choose and use the right medicines, and as a base to the relevant authorities make check monitoring, management.
The label includes all the labels and printed, written or stickers on the packaging of the products or on the packaging, cans containing that product, excluding the container.
2.11 Special reserves: is the condition of the drug, raw material, are to separate, in a quarantine area or by administrative measures to wait decided to handle the cancel or allow the export or warehousing warehouse for the manufacture, packaging or distribution.
2.12 FIFO is the acronym of the English "First In/First Out", meaning "enter before-front".
FEFO is the acronym of the English "First Expired First Out", meaning "to expire before – made before".
2.13 the is infection Junk we don't desire the impurities have a chemical or microorganism, or foreign objects into the raw materials, semi-finished products, finished products in the manufacturing process, sampling, packaging, packing, storage and transport.
cross-contamination of 2.14 is the magazine of contamination of raw materials, intermediate products or drug products with other drugs or raw materials in process of manufacture, storage and transportation.
Part II GOOD STORAGE PRACTICE 1. HR: 1.1. According to the unit's scale, drug inventory must have sufficient qualified staff, consistent with the assigned jobs working in the warehouse area. All employees are regularly trained on "good practice to preserve", professional skills, and must be defined clearly the responsibility, the work of each person writing.
1.2. The key staff of the monitoring function, inventory check, need honest, have the necessary experience, knowledge and professional degree and techniques consistent with the assigned task, meet the regulations of the State.
1.3. the storekeeper with the necessary knowledge about medicine, about preservation services: the method of preservation, management methods and import tracking books, drug quality ...
1.4. The seat must have a minimum level of inventory is high pharmacists for the manufacturing, wholesale medicine. For manufacturing, wholesale smoking traditional medicine, medicinal herbs, store keeper must have minimum levels are stipend pharmacy or pharmacist.
1.5. poison storekeeper, addictive drugs and smoking mental direction must meet the regulations of the relevant law.
1.6. Storekeepers are trained regularly updates the new rules of the State of preservation, management, methods, scientific advances are applied in storage.
2. Warehouses and equipment:

The warehouse must be designed, constructed, equipped, repair and maintenance in a way so that the system can protect the drug, raw material, to avoid the possible adverse effects, such as: the change of temperature and humidity, waste and odor, animals, insects, insect, drug quality assurance.
2.1 location: storage must be built in high places, safety system must have drains, to ensure the drug, raw material, to avoid the influence of groundwater, rain, and floods.
The repository must have an address defined, is in place for importing, transporting, protect.
2.2 design, build: a-Shed is wide enough, and when necessary, should have the separated between the areas to ensure the preservation of quarantine of each drug, each shipment as required.
b-depending on the purpose, scope of the warehouse (warehouse of the manufacturer, the Distributor's warehouse, warehouse of hospital pharmacy ...) need to have those areas identified, is built, reasonable layout, equipped with suitable: + reception area, storage and preservation of drugs, raw materials waiting to enter the warehouse.
+ The area sampled drugs, raw materials: this area must be built, equipped with suitable and must have systems that provide clean air guarantee required by the sampling.
+ Conservation areas.
+ Conservation areas, raw materials require special preservation;
+ Conservation areas, the material does not meet the quality standard, pending;
+ Conservation areas of raw materials, finished products exported the repository waiting for production or allocate;
+ Packing area, travelers and labeled;
+ Conservation areas of the packaging;
+ Special preservation area in storage before the materials;
c. the warehouse must be designed, built, arranged to meet the requirements on the way back, escape, fire systems, fire.
d-the ceiling, the walls, the roof, the repository must be designed, built, ensuring the rotation of air, firmly against the influence of the weather as the Sun, rain, storms and flooding.
Background-the repository is high enough, flat, smooth, hard, and sure enough be treated against moisture, waterproof to ensure operation of the staff working in the warehouse, and the operation of motor vehicles. Background the repository must be free of cracks, slots dextral.. where are the accumulation of dust, the refuge of vermin, insects.
2.3 equipment warehouses must meet the following requirements: a-have the facilities, the equipment fit: exhaust fan, air-conditioning system, truck, forklift, thermometers, humidity ... to ensure the conditions for preservation.
b-there is enough light guaranteed to activities in the area of the repository are correct and secure.
c-There are enough equipment, shelves to sort the goods. Not to drugs, raw materials directly on the repository. The distance between the racks, between the shelves warehouse are wide enough to ensure the sanitary inspection, warehouse, collated, and folded, unloading.
d-had enough of the equipment, the essential guide for fire and explosion prevention, such as: automatic fire alarm system, sand bucket, water system and fire hydrants, gas cylinders, fire sprinkler systems ...-There are rules govern out into the warehouse area , and to have preventative measures, preventing out of people.
the e-regulations and measures to combat the penetration, the development of insects, vermin, rodents ...
2.4 the conditions are preserved in the repository: in principle, the conditions of preservation must be a condition indicated on the label of the drug. As defined by the World Health Organization, regular preserving condition is preserved in a dry, airy conditions, and temperatures from 15 to 250 c or depending on climatic conditions, the temperature can be up to 300C. To avoid harsh direct light, the smell from the outside in and signs of pollution.
If the label does not indicate the condition of preservation, the preservation in normal conditions. The case record is preserved in a cool place, frozen ... ... then apply the following rules: a-temperature: storage temperature: room temperature in about 15-250 c, in each time the temperature can go up to 300C.
Cool: temperatures in the range of 8-150C.
Cold storage: temperatures do not exceed 80 c. Refrigerator: the temperature in the range of 2-80 c.
Cold storage: temperatures do not exceed-100 c.
b-humidity: "dry" preservation conditions are interpreted as relative humidity not exceeding 70%.
2.5 storage Warehouses, raw materials require special preservation: a-special measures should be taken for the storage of poisons, substances sensitive to light, temperature, humidity ..., active substances, high and dangerous substances, such as: liquid, solid, gas fire addictive drugs, and similar substances, drugs and highly toxic chemicals, radioactive materials, pharmaceutical chemicals.
b-The drug, raw material, require special preservation conditions, need to be stored in separate areas are built and equipped to ensure the conditions required for preservation and the regulations of the law.
c-for the liquid explosive, solid, the compressed air ... must be preserved in the repository are designed, constructed and suitable for the storage of flammable products as required by the law, is far from the other repository and housing areas to clear Inventory. and are equipped with lamps. The power switch must be set in addition to the repository.
d-for addictive drugs, poisons, smoking mental direction: must be preserved in the repository meet stipulated in the relevant regulations.
-The smell of drugs and chemicals such as ammonia, types of essential oils, tinctures ... need to be preserved in sealed packaging, in the private sector, avoiding to absorb odor on other medications.
e-for drugs requiring controlled preservation conditions of temperature, humidity, light, these conditions should be tracked and ensure sustained.
The equipment used to track conservation conditions: thermometer, humidity ... must be checked periodically, when necessary, calibration and test results, this correction must be recorded and stored.
g-sampling area, or providing travelers the raw materials, product packaging, wait need to separate from the other preservation area, and must be equipped, have the dụngcụ necessary for conducting the work, must have enough supplies and equipment emissions, prevention of cross-contamination, contamination of impurities.
h-Must implement appropriate measures to prevent the cross-contamination, contamination and impurities to provide safe working conditions for workers.
3. Hygiene: 3.1 preservation area should be clean, no dust, rubbish accumulates and no insects insects. Must have written sanitation program rules, clearly define the frequency and methods of factory hygiene, storage.
3.2 all storekeepers, workers working in the warehouse must be periodic health checks. People with respiratory diseases, or have open wound are not working in the conservation area are directly processed (raw materials, finished products, ...) are also openings.
Where hand washing, toilet rooms must be well ventilated and appropriate layout (with glass reception area, preserved, processed, smoking).
3.3 workers working in the warehouse area must wear protective clothing appropriate to the labor.
4. The maintenance procedures 4.1 General requirements: a-drugs, raw materials need to be preserved in the conditions to ensure the quality of them. Drugs, raw materials need to be rotated to give the plots received before or have limited use before will bring used before. Previous entry guidelines-previous (FIFO-First In/First Out) or expire before – front (FEFO-First Expired First Out) need to be made.

b-Smoking waiting to remove the need to have clear labels and special reserves to prevent the production, circulation, use.
c-depending on the nature and conditions of preservation of the products, to mandate the inspection program, reviews periodically or irregularly to determine the quality of the product.
d-books system, must have the standard operation procedure to ensure for the preservation, control and monitor the import and export of drug quality.
4.2 label and packaging.
a-The medicines must be stored in suitable packaging, do not adversely affect the quality of the drugs, and has the ability to protect the drug from the influence of the environment, in some cases, when required, this includes both work against infections.
b-all over the packaging of the medication must be labeled clearly, easy to read, full of content, form meets the regulations of the law on trademarks and the label of the drug. Do not use the abbreviated name, drug name or code.
c-for every type of packaging, labels or product, to have the record separate records, which indicate the condition of preservation, precautionary measures should be noted and expiration (if any).
d-to have a separate area to preserve the label and the packaging was printing. Are there specific rules for the import, packaging and label types.
DD-must comply with the requirements of Pharmacopoeia and the legal regulations concerning labeling and packaging.
4.3 receiving medication.
a-the reception smoking must be done in the area dedicated to the reception of drugs, separated from the area preserved. This area must have the conditions to preserve to protect the drug from the bad influence of the weather during the time waiting for unloading, check out smoking.
b-Smoking before entering the repository must be examined, collated with the documents related documents about the type, amount, and other information recorded on labels like every name, manufacturer, supplier, batch number, expiration ... c-shipments must be checked for uniformity, and if necessary , divided into small batches according to the batch number of the provider.
d-all packaging needs to be examined carefully on the level of contamination and the extent of the damage, and, if necessary, should be cleaned or to own the packaging damaged, contamination to look to find the cause. All drugs have the packaging is damaged, take the seal or suspected contamination of impurities must be preserved in special storage areas for processing, not to be sold, or to be with other drugs.
DD-these drugs require special preservation conditions (the addictive drug, poison, drugs that need preservation in cold temperatures, ...) must quickly be examined, classified and preserved according to the instructions indicated on the label and according to the regulations of the law.
e-to have and save the records recorded for each type of cargo, with each shipment. The records must show the drug name, form of the drug, the concentration levels of, quality, quantity, batch number, expiration, production time, and code (if available). Need to comply with the regulations of the law on archive records.
g-the sampling of drugs to quality check must be conducted in the area for the sampling, and by people with the expertise done. The sampling must be as defined in the regulations of drug sampling to determine quality.
Batches of the drug, raw material, has to be sampled must be preserved especially in storage. The plot of the drug must be to separate during storage and differences in the storage time.
h-special storage mode must be done either by using a separate conservation area, or by the system of electronic data processing.
The measures are applied need enough safety to prevent the use or dispensation, the material has not been controlled, tested or do not meet the stipulated requirements.
I-drugs, raw materials need to be kept in special storage mode until accepted in writing or removal of quality inspection. Security measures need to be taken to ensure the drug, the material removed will not be used. While waiting for the decision to cancel, reprocess or return the provider, the drug, this material must be stored separately with drugs, other materials allocated revolving warehouse-4.4.
a-Only allocated the drug, raw material, quality standards, also in term of use. Not allocated, distribution of the drug, raw material, not intact packaging, or have doubts about quality.
b-right there and save the records (import track votes, the votes of drug quality monitoring ...) expresses all the times entered the warehouse, warehouse of drugs, raw materials match the production batch number.
c-allocation need to adhere to the principle of Rotary (pre-pre-production expires or before), especially smoking, limited materials used. Note When a drug, raw material, the following entry is limited to shorter drug use, materials of the same type are entered before the drug, raw material, have shorter expiration must be allocated before export.
d-The barrel, including medicine, raw materials have been used a part need to be sealed again safely to avoid the scattered or cross-infection, contamination of impurities in the storage time.
e-The barrel, how smoking damaged materials, not intact, sealed, lost or torn labels, labels are not clear, then not sold, allocated, and must immediately notify with the quality control Department.
4.5 maintenance medication.
a-The conservation conditions are required, such as: type of packaging, limited to the temperature, the humidity, the protecting light ... should be maintained during storage time. Need to have the attention to the medication contains active ingredients of inferior firmly for temperature, humidity, light ... (Refer to Appendix-directory of some active ingredients less firmly) b-drug packaging must be kept intact during the process of preservation. Do not use mixed packaging of this type for other types.
c-poison, addictive drugs, smoking mental direction must be preserved in accordance with the regulations in the relevant regulations.
The temperature-sensitive medications must be stored in cold storage or refrigerated. The temperature in storage must be examined in the different positions of the repository.
The light-sensitive medications must be stored in sealed packaging, not for light transmission, in a dark room.
The volatile drugs and drugs that are sensitive to moisture must be preserved in cold storage, hermetic packaging. The strong desiccant must be preserved in a dry room, glass or plastic bag sealed. If the button is covered with paraffin.
The smell of drugs must be stored in sealed packaging, in a private repository.
Medicinal herbs must be preserved in a dry, airy warehouse. The barrel must be streamlined to ensure air circulation. The appropriate materials to packaging to preserve medicinal herbs can be glass, plastic, paper ... The medicinal herbs contain essential oil also needs to be preserved in sealed packaging.
The flammable, explosive must be stored in a separate repository, meet the regulations of the law.
d-Must periodically conducted the reference drug in the repository by comparing extant drug and weight remain under import tracking votes. In all cases, the collation must be conducted when each shipment is used up.
DD-all wrong, losses should be investigated to find out the cause due to confusion, negligent or other wrongful issues.
e-check regularly the batch number and expiration to ensure import guidelines before-before or prior to expiration-export compliance, and to be found near off or out of date.

g-periodically test the quality of the goods stored for the detection of metamorphism, damaged during maintenance due to conditions of temperature, humidity or other factors can affect the quality of the drug, raw material.
h-drugs, substandard raw materials quality, expired user must be preserved in the private sector, are labeled, you smoking, raw materials processing. To have precautionary measures the allocated, use of drugs, raw materials used, the drug has expired, the material does not meet the quality standards.
I-must have the means of transportation and preservation in order to ensure appropriate for smoking, avoiding disruption and material damaged caused by the climatic conditions exceed defined as hot, wet ... during the process of transportation, preservation to note those drugs, raw materials require special preservation conditions.
5. Smoking returns 5.1 all the drugs were out of stock, bounced to be preserved in special areas. These drugs are only sent back to the arsenal of drugs to the circulation, distribution, use, after quality assurance Department reviews the standard of quality and safety for the user.
5.2 all returns, after quality assurance Department reviews is no guarantee of quality, do not ensure the safety of the user shall not be put to use and must be disposed of according to the regulations of the law.
5.3 The medicines because patients must be returned to the private sector, waiting for cancellations.
6. Send the item (shipping the drug by sending the row) 6.1 The allocate and queue up only vehicles made after having shipment orders in writing.
The principles, regulations about the process of shipping the drug by sending orders (dispatch) must be set according to the nature of the drug and after considering all the precautions.
6.2 with regard to the drugs require special preservation, during transport, to ensure the maintenance of conditions there.
6.3 The shipping the addictive drugs, poisons, smoking mental direction must comply with the regulated in the regulations concerned.
6.4 The shipping packaging must protect the drug to avoid external influences and must be clearly labeled, not erasing or prone to erasure.
6.5 transport shipping documents must specify:-the time of shipping.
-Customer name and address.
-The name and address of the sender.
-The name and address of the carrier.
-Drug Name, form, size, quantity and batch number.
-Transport, storage conditions.
6.6 all documents related to the transportation, shipping must be stored at the sender and receiver, and preserved in a safe place.
7. the document profile.
7.1 operation process: the need to have available, easy-to-read place the hanging process manipulating the approved standard defines the working methods in the area of the warehouse. The process must accurately describe the process of receiving and examining drug warehousing, storage, cleaning and maintenance depots, equipment used in preservation (including the process of checking, insect control, rat flea), regulations on the preservation conditions notes safe smoking Depot, and in the process of shipping, the dispensation, the records, including the records of customer orders, returns, the recovery process and determine the way of smoking, and of information .... The process must be negotiated, signed and dated by the review authority.
7.2 Is there a system of books suitable for recording, monitoring the import of drugs, including the drug name, batch number, expiration, quantity, quality, drug suppliers, manufacturers ... meet the regulations of the law. If the type of the books are in computer culture, they must comply with the regulations of the law. Must have the mandate, specific precautions to avoid intrusions, repair, use an illegal way the data is stored.
-Import tracking smoking Votes (sample attached 1-GSP/MB)-drug quality tracking Votes (sample attached 2-GSP/MB)-The other form as defined by the relevant Ministries.
Are there import tracking smoking votes separately for each product type and for each kind of specification products.
For the reception, poison, addictive drugs, smoking mental direction must follow strictly the regulations of document profile in the relevant regulations.
Part III GUIDELINES 1. General rules: 1.1. The unit of export and import, trafficking, drug storage, storage warehouse service, hospital pharmacy, research institutes, the medical centre must develop a step-by-step plan to invest to upgrade, build the arsenal of drugs under the principle of "good storage practice".
1.2. The drug manufacturing units in the process of implementing the standard rules apply "good manufacturing practices" at the same time to deploy the application of the principles of good practice "storage".
2. Implementation: training 2.1 a-Ministry of health (the Vietnam pharmaceutical Management Bureau) popular organizations, training on "good practice to preserve the drugs" for the Vietnam Pharmaceutical Corporation, the provincial health department, central cities, health departments, the production units, the business, the Central Hospital, and the hospital has beds.
b-provincial health department, central cities, Vietnam Pharmaceutical Corporation, health departments are responsible for dissemination, training, and training in the principles of "good practice to preserve the drugs" for the unit, including the hospital pharmacy, Research Institute and Medical Center closed.
c-The popular self training units of the principle "good storage practice" for staff members of the unit.
2.2 registration procedures and authority check.
2.2.1 registered check the unit, after the self test, reviews his base of standard "good practice to preserve", submit the registration records check "good practice" to preserve the Health Ministry (the Vietnam pharmaceutical Management Bureau). Registration documents are:-the registration check "good practice to preserve" (attached form 3-GSP/MB)-program, content and results of the training of "good practice" in the storage facility.
-Organization, staffing of the facility.
-Diagram of the geographic location and design of the repository.
-Environmental assurance certificate of the competent authority.
-The category of the equipment maintenance of the facility.
-Category category items preserved in the repository.
-Automatic inspection record "good practice to preserve" the registration profile is made up of 3 sets, sending about Vietnam drug administration.
2.2.2 registration documents re-examined: registration documents re-examined included:-A register re-examined "good practice to preserve the drug"-reported payroll changes, the Organization of workshop facilities in 2 years "good practice to preserve the drugs".
-Summary report about the program, the contents and results of training "good storage practice" at the facility in 10 years.
-Automatic inspection reports, and reviews of the most recent batch of facilities in implementing "good storage practice".
2.2.3 competence test and certification: the Vietnam pharmaceutical Management Bureau is responsible for receiving, evaluating the registration records check, Union test basis and granted certificate of standard base "good storage practice".
the criteria of 2.2.3.1 officers examined good practice to preserve the drugs:-University degree or above, experienced in management of pharmacy in General and storage in particular.
-Honest objective.

-Have the scientific working methods, determined strictly obey the rules, regulations, have the ability to quickly detect the flaws of the basis, at the same time to be persuasive measures helped overcome shortcomings.
2.2.3.2 the registration dossier evaluation test practised well preserved.
After getting enough registration records check "good storage practice" of basis as required (properties 2.2.1 and 2.2.2), the Vietnam pharmaceutical Management Bureau in conjunction with experts of related agencies appraise records (there are minutes of the appraisal records). Within 30 days of receipt of a valid application, Vietnam Drug Administration has decided to set up the test group to examine "good storage practice" at the facility. If the profile is not yet fully meet the requirements, the Vietnam drug administration must have the written reply basis and stating the reason.
2.2.3.3 test and certification:-test group composition: Vietnam drug administration and the Department of health, the central city where corporate headquarters.
-Report on the check must be in charge of the base and the head of the delegation check signatures, be made in 3 copies: 1 a save at the base, 1 a save in Vietnam drug administration and 1 a medical in the central cities, where the unit headquarters.
After the check, if the facility meets the principles of "good practice" preservation, Ministry of health (the Vietnam pharmaceutical Management Bureau) will the certification standard of "good practice" storage. The certificate of "good practice to preserve the drugs" worth 2 years from the date of signing. Before the expiration of 3 months, the facility must do the registration procedures re-examined as defined in 2.2.2, 2.2 points, section 2, part III of the guidelines. If the required standard, the basis will be continued in the new certification.
Periodically check the "good storage practice" 2 in 1 times, except in the case of irregular due to the base or the Ministry of health (Drug Administration) requirements.