Quyết định 2701/2001/QD-BYT

Decision No. 2701/2001/QD-BYT dated June 29, 2001, application of “good storage practices” principle

Decision No. 2701/2001/QD-BYT application of good storage practices principle đã được thay thế bởi Circular 36/2018/TT-BYT good storage practices for medicinal products and medicinal materials và được áp dụng kể từ ngày 10/01/2019.

Nội dung toàn văn Decision No. 2701/2001/QD-BYT application of good storage practices principle


THE MINISTRY OF HEALTH
-------

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom - Happiness
--------------

No.: 2701/2001/QD-BYT

Hanoi June 29, 2001

 

DECISION

APPLICATION OF “GOOD STORAGE PRACTICES” PRINCIPLE

THE MINISTER OF HEALTH

Pursuant to the Law on People’s Health Protection dated July 11, 1989 and Statute of preventive and treatment drug enclosed together with Decree No. 23/HDBT dated January 24, 1991 of the Council of Ministers (now the Government);

Pursuant to the Ordinance on goods quality dated December 24, 1999;

Pursuant to the Decree No. 68/CP dated October 11, 1993 by the Government stipulating functions, duties, authorities and organizational structures of the Ministry of Health;

Pursuant to the Decree No. 86/CP dated December 08, 1995 of the Government stipulating assignment of state management responsibilities for goods quality;

At the proposal of General Director of Drug administration of Vietnam,

DECISION

Article 1. Developing application of “Good storage practices” principle enclosed together with this Decision to pharmaceutical manufacturers, importers, exporters, wholesalers, contractors, drug storage and conservation service companies, hospital’s pharmacy departments, Research Institute and medical centers.

Article 2. This Decision is effective after 15 days since the date of signing and promulgating.

Article 3. Mr. General Director of Drug administration of Vietnam shall be responsible for instructing, inspecting and monitoring the application of the principle “Good drug protecting practice”.

Article 4. The Chief Officers, the Chief Inspector of the Ministry of Health, General Director of Drug administration of Vietnam, heads of agencies under the Ministry, directors of provincial and municipal departments of health under the Center, head physicians of various branches are responsible for executing this Decision.

 

 

PP MINISTER OF HEALTH
DEPUTY MINISTER




Le Van Truyen

 

PRINCIPLE

“GOOD STORAGE PRACTICE”
(Enclosed together with the Decision No. 2701/2001/QD-BYT dated June 29, 2001 of the Minister of Health)

Part 1.

GENERAL PART

1. Purposes.

To ensure supply of quality drug to consumers, it is required that all the stages ranging from production, conservation, storage, circulation and distribution of drug are well implemented.

Good storage practices are special and suitable measures for storage and delivery of materials and products from production, conservation, storage, delivery and distribution to ensure the drug attain intended quality when reaching consumers.

This document stipulates basic principles and general instructions on “Good storage practices”. However, these principles, guidances can be modified to meet particular requirements but still ensure intended quality.

The principle “Good storage practices" applies to pharmaceutical manufacturers, importers, exporters, wholesalers, contractors, drug storage and conservation service companies, hospital’s pharmacy departments, Research Institute and medical centers.

2. Interpretation of terms

Terms used in this Principle are construed as follows:

2.1 Drug storage means safe storage of drugs, materials including putting into use and sufficiently maintaining appropriate systems of documents and materials including receipts and delivery orders.

2.2 Drugs means products that originate from animals, plants, minerals, pharmaceutical chemistry or biology and processed for human use, in order to:

- Prevent and treat diseases

- Restore and adjust physical functions of human bodies

- Reduce symptoms of diseases

- Diagnose diseases

- Help recover or improve health

- Desensitize part or whole of the body.

- Influence reproduction processes.

- Change body shapes

2.3 Materials mean substances active or inactive, changeable or unchangeable used in manufacture of drugs. They include active ingredients, excipients, reagents, solvents, intermediary products, packages and labels.

2.4 Active ingredient means pharmaceutically active substances or compounds used in manufacture of drugs.

2.5 Excipient means substances, other than active ingredients, adequately assessed of safety and put into drug distribution system.

2.6 Packages mean every material used for packaging products except containers used to store products and transported by various means of transport to recipients.

2.7 Intermediate product means a partly processed material which must undergo further processing before becoming a finished product.

2.8 Finished product means medicinal products having undergone all stages of production including packaging.

2.9 Retest date means The date when drug, materials should be re-examined to ensure that it is still suitable for use.

2.10 Labels mean printouts, pictures, images, signs being engraved, embossed or attached directly to commercial packages to convey crucial information of that drug, helping users to choose and use right drug and functioning as the basis for functional agencies to carry out inspection, supervision and management.

Labels include all labels, texts or images printed, written on intermediary packages or on packages or wrappers of that product except containers.

2.11 Isolation means the status of materials or products set apart physically or by administrative system pending rejection or release for processing, packaging or distribution.

1.12 FIFO means an acronym for “First In/First Out”.

1.12 FIFO means an acronym for “First Expired/First Out”.

2.13 Contamination means unexpected appearance of impurities of chemical or microbiological nature, or foreign matters in the raw material, intermediate products, finished products during manufacture, sampling, packaging, re-packaging, storage and delivery.

2.14 Cross-contamination means the contamination of materials, intermediary products or finished products with other materials and products during manufacture, storage and delivery.

Part 2.

GOOD STORAGE PRACTICES

1. Staff:

1.1. According to the organization’s scale, storage site must be adequately staffed by those who are qualified for assigned tasks. Every staff must be regularly trained in “Good storage practices”, professional skills and clearly defined in writing in terms of responsibilities and duties of each person.

1.2. Storage site’s key officers functioning as supervisors, inspectors must be honest, have necessary knowledge, experience and professional and technical qualifications suitable for assigned tasks according to state regulations.

1.3. Store keepers must acquire necessary knowledge of pharmacy and drug storage such as method of storage, method of managing stock inventory and drug quality...

1.4. Store keepers must be certified at least an associate degree in pharmacy to work for modern medicines manufacturing and trading facilities. With respect to facilities manufacturing and trading traditional medicine, herbal ingredients, store keepers must be certified at least as pharmacy aides, pharmacy technicians.

1.5 Keepers of storage sites that have toxins, narcotics and psychotropic drugs must meet relevant regulations.

1.6. Store keepers must be regularly trained and updated with new regulations on drug storage and management, scientific and technical advances applied to drug storage.

2. Stores and facilities:

Stores must be designed, constructed, equipped, renovated and maintained systematically to facilitate protection of drugs and materials against possible adverse effects such as changes in temperature and humidity, waste and odor, animals, plants, and insects ensuring intended quality of drugs.

2.1 Location:

Stores must be constructed on a high, dry and safe place with a drainage system being installed to ensure drugs and materials are protected from effects of underground water, heavy rains, storms and flooding...

Every store must have a specific address, situated in a place favorable for reception, shipment and protection..

2.2 Design, construction:

a- Stores must be spacious enough and if necessary, separation can be established to ensure isolation of each type and batch of drugs on request.

b- Depending on purpose and scale of stores (manufacturer’s stores, distributor's stores, hospital’s pharmacy department’s stores...), some specific areas must be determined, constructed and equipped suitably.

+ Area for receiving, isolating and storing products, raw materials pending stocking.

+ Area for taking samples of products, materials: this area must be constructed and equipped suitably and have a clean air supply system to ensure requirements of sampling.

+ Area for storing drugs.

+ Area for storing drugs, raw materials of special storage requirements.

+ Area for receiving and storing drugs, raw materials failing to meet quality standards, awaiting handling;

+ Area for storing raw materials, finished products taken out for being put into production or dispensation;

+ Area for packaging, classification and labeling;

+ Area for storing packages;

+ Area for isolating materials before dispatch;

c. Stores must be designed, constructed and arranged in such a manner as to facilitate traveling, escape, fire prevention and control system.

d- Ceiling, wall, store roof must be designed, constructed to ensure ventilation, circulation of air, able to resist effects of sun, rain and storm.

dd- Storage areas must be high, flat, smooth, sufficiently firm and treated to withstand humidity and penetration, ensuring operation of store keepers and motor vehicles. Storage areas must not have fractures, slots... as places for accumulation of dirt and shelter of insects.

2.3 Facilities:

Stores must meet the following requirements:

a- Appropriate devices and equipment: blowers, air-conditioners, trucks, bucket truck, thermometer, hygrometer... are provided to ensure storage conditions.

b- Lighting in the warehouse must be adequate to enable all operations to be carried out accurately and safely.

c- Stores must provide adequate equipments, supports, shelves for arrangement of products. Products, materials are not allowed to be placed directly on the ground. Distances between the shelves and from the shelves to the floor must be enough to enable cleaning, inspecting, checking, dispensing and loading products.

d- Stores must provide adequate facilities and instructions necessary for fire prevention and fighting tasks such as automatic fire alarm system, sand box, fire hydrant and hose system, fire extinguishers, automatic fire prevention and control system...

dd- Regulations must be imposed to prevent unauthorized persons from entering storage areas

e- Regulations and measures must be taken to prevent intrusion and growth of insects and rodents...

2.4 Storage conditions:

Storage conditions, in principle, must be those that are required on labels. According to the WHO's regulations, normal storage conditions are storage in dry, well-ventilated premises at temperature of 15-250C or depending on climatic conditions, up to 300C. Extraneous odors, other indications of contamination, and intense light must be excluded.

If storage conditions are not clearly written on labels, normal storage conditions should be applied. In case storage in cool, freeze places is required on labels, the following instructions are recommended:

a--Temperature:

Controlled room temperature of 15-250C: depending on each period of time, temperature can reach up to 300C.

Cool storage temperature: from 8-150C

Cold storage temperature: Not exceeding 80C. Freezer temperature: from 2-80C

Dry ice: Not exceeding 100C.

b- Humidity: “dry” storage conditions are construed as relative humidity (not over 70%).

+ Area for storing drugs, materials of special storage requirements.

a- Special measures should be taken for the storage of toxins, materials sensitive to light, temperature, humidity..., highly active and dangerous materials such as combustible liquids, solids and pressurized gases, narcotics, highly toxic pharmaceutical products and chemicals, radioactive materials and herbal ingredients.

b- Pharmaceutical products, materials requiring special storage conditions shall be stored in an isolation area which is suitably constructed and equipped to ensure storage conditions according to requirements and regulations of the law.

c- For combustible solids, liquids, pressurized gases..., they should be stored in a store suitably designed and constructed to enable storage of combustible products according to the law and located far away from other stores and residential areas. Stores should provide adequate ventilation and flameproof lights. Electric switches should be positioned outside of stores.

d- For toxins, narcotics and psychotropic drugs, they should be stored in the areas meeting relevant regulations and statutes.

dd- For pharmaceutical products, chemicals with detectable smells such as essential oils, ammonia and tinctures..., they should be stored in closed packages in isolation areas to avoid mixing up with other drugs.

e- For pharmaceutical products requiring controlled storage conditions in temperature, humidity and light, these conditions should be monitored and guaranteed to be constantly maintained.

Equipment used to monitor storage conditions such as thermometers, hygrometer...must be periodically inspected, corrected when necessary, and the results from inspection, correction should be recorded and kept in archives.

g- Areas for sampling, or dispensing materials and products pending packaging should be separated from other storage areas and adequately equipped with necessary equipment for air supply and discharge, contamination and cross-contamination prevention.

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

3. Sanitation:

3.1. Storage areas should be kept clean without accumulated dirt and insects. Documents stipulating sanitation program should be promulgated, frequency and method of cleaning stores and facilities be clearly defined.

3.2 All store keepers, workers working in the storage area should have regular check-ups. Any one suffering respiratory tract related diseases or open wounds shall not be allowed to work in the storage area where they work directly with drugs (materials, finished products...)Hand washing areas and restrooms must provide adequate ventilation and be appropriately arranged (isolated from areas of reception, storage and treatment of drugs).

3.3 Workers working in the storage area should wear appropriate protective clothing.

4. Storage procedures

4.1 General requirement:

a- Pharmaceutical products, materials should be stored in such conditions as to ensure their quality. Pharmaceutical products, materials should be rotated so that FIFO or FEFO principles are complied with.

b- Pharmaceutical products pending rejection should have clear labels and stored in isolation to prevent them from being put back into production, circulation and use.

c- Depending on characteristics of products and storage conditions, a regular or unexpected program of inspection and assessment should be planned to determine product quality.

d- A standardized system of records and operation procedures should be available to facilitate storage, control, monitoring of reception, dispatch and drug quality.

4.2 Labels and packages

a- Pharmaceutical products should be stored in appropriate packages in order not to adversely affect quality of products, and at the same time to be able to protect products against impact of the environment, and in certain circumstances, antibacterial factors if requested.

b- Labels attached to product packages must be clear, readable and written with adequate information and manners meeting regulations of the law on labels and trade marks of pharmaceutical products. Use of acronyms for drug names or codes is not permitted.

c- Each type of package, label or product should be accompanied by particular records describing storage conditions, precautions and expiry date (if any)

d- A separate area should be available to store product labels and printed packages. Specific regulations should be issued to facilitate reception, dispense of these labels and packages.

dd- Requirements of pharmacopoeia and regulations concerning labels and packages should be complied with.

4.3 Reception of products.

a- Reception of products should be carried out in an area intended for reception of products and isolated from storage area. This area should provide storage conditions for protecting products against adverse effects of weather during the process of loading and inspection of products.

b- Products before being received should be inspected and checked against documents, receipts concerning type, quantity and other information as described on the label such as product name, manufacturer, supplier, batch number and expiry date...

c- Batches should be inspected in its uniformity and if necessary, divided into small batches according to batch numbers of the supplier.

d- All packages should be carefully checked for contamination and damage. If necessary, contaminated or damaged can be cleaned or separated for determination of causes of such contamination or damage. All products contained in packages being damaged, lost of seal or showing signs of contamination should be stored in an isolation area pending treatment, and must not be sold or mixed up with other pharmaceutical products.

dd- Products requiring special storage conditions (narcotics, toxins and other materials requiring cold storage...) should be inspected quickly, classified and stored according to instructions described on the label and regulations of the law.

e- Archive of records for each reception of products and each batch should be available on request. These records should be fully described with such information as product name, dosage form, concentration, content, quality, quantity, manufacture batch, expiry date, date of reception and codes (if any). Regulations of the law on archive of records should be strictly complied with.

g- Sampling for quality inspection should be carried out in an area intended for sampling and undertaken by qualified staff. Task of sampling should meet regulations set out in the Statute on sampling of drugs for quality determination.

Batches, materials taken sample should be stored in isolation.  Batches of products should be stored in isolation during a period of isolation and next storage period.

h- Isolation regime should be carried out either by use of special storage area or use of electronic data processing system.

Measures taken should ensure adequate safety to prevent use or dispense of products, materials which have not undergone testing, inspection or failing to meet requirements as regulated.

i- Products, materials should be stored in isolation until a written approval or rejection by quality inspection division is released. Security measures should be taken to ensure rejected products, materials are not put back into use. While awaiting a decision for rejection, re-processing or returning to supplier, these products, materials should be stored in isolation from other products, materials.

4.4 Dispense – stock rotation

a- Only products, materials being unexpired and meeting quality standards are dispensed. Dispense and delivery of products, materials of broken packages or uncertain quality is prohibited.

b- Records (dispatch and receipt notes; quality control sheets) on which the number of receipts and dispatches of products, materials is consistent with the number of batches.

c- Dispensing of products should comply with principles of stock rotation (first in – first out or first expired – first out), especially products, materials having limited life. When shelf-life of a successively received product, material of is shorter than that of the product, material of the same category previously received, those of a shorter shelf-life shall be dispatched and dispensed first.

d- Boxes, packages of once used products, materials should be safely sealed to avoid scattering or contamination, cross-contamination during the maintenance period.

e- Boxes, packages of products, materials being damaged, lost of seal, labels or with labels torn or unreadable shall not be permitted for sale, dispense and should be notified immediately to quality control department.

4.5 Storage of drugs

a- Such storage conditions as package types, temperature limit, humidity and lightproof protection....should be maintained during the period of storage. Attention should be paid to products containing active ingredients sensitive to temperature, humidity and light...  (Refer to Appendix – List of some less persistent active ingredients)

b- Packages of products should be kept intact during storage. Do not confuse packages of this kind with others.

c- Toxins, narcotics and psychotropic drugs should be stored in accordance with regulations of the relevant Statute.

Pharmaceutical products sensitive to temperature should be stored in cold or frozen storage conditions. Storage temperature should be inspected at different positions in the store.

Pharmaceutical products sensitive to light should be stored in closed lightproof packages in dark area.

Pharmaceutical products volatile and sensitive to humidity should be stored in cold conditions, packages sealed. Strongly hygroscopic substances should be stored in glass or plastic packages closely sealed in a dry room. If possible, the stopper should be covered with paraffin.

Odorous products should be stored in sealed packages in a separate store.

Herbal ingredients should be stored in a dry and well-ventilated store. Boxes of products should be suitably arranged to enable circulation of air Materials appropriate for production of packages storing herbal ingredient can be glass, plastic and paper... Herbal ingredients containing essential oil should be stored in sealed packages.

Combustible and explosive substances should be stored in a separate dry store, meeting regulations of the law.

d- Regularly carry out checking inventory by comparing existing stock against the stocks described in dispatch and receiving follow-up vouchers. In all circumstances, the checking should be carried out when each batch is used up.

dd- All discrepancies and losses should be investigated to determine the cause due to errors, recklessness or other wrongdoings.

e- Inspection of batch number and shelf-life should be regularly carried out to ensure the principle “first in – first out”, or “first expired – first out” is complied with, and to detect whether products are sold out or expired.

d- Quality inspection of products in stock should be regularly carried out to detect degradation or deterioration during storage due to temperature and humidity conditions and other factors which may affect quality of products, materials.

h- Products, materials failing to meet quality standards or being expired should be stored in isolation, attached with labels, signboards for handling. h- Precautions should be taken to cope with dispense and use products, materials failing to meet quality standards or being expired.

i- Appropriate transportation and storage means should be available to ensure products, materials are not broken and damaged due to excessive climatic conditions according to the regulations such as hot sun and moisture...During the process of transportation and storage, attention should be paid to products, materials subject to requirements of special storage conditions.

5. Returned products

5.1 All products dispatched, returned should be stored in an isolation area. These products can be returned to the store for circulation, delivery and use only when they are evaluated by the quality assurance department as having met quality standards and ensured safety to users.

5.2 All returned products after being evaluated by the quality assurance department as failing to meet quality standards and safety to users shall not be put back into use and handled according to the law.

5.3 Products returned by patients should be stored in isolation pending rejection.

6. Dispatch

6.1 Dispensing and loading products onto transport vehicles are carried out only after a delivery order is released.

Principles, regulations on dispatch procedures should be established depending on the nature of products and after all precautions are put into consideration.

6.2 For products of special storage requirements, maintenance of regulated conditions should be ensured during transportation.

6.3 Transport of toxins, narcotics, psychotropic drugs should conform to the regulations as out in relevant Statute.

6.4 Outside containers should provide adequate protection from all external influences and should be indelibly and clearly labeled.

6.5 Records of dispatch should state:

- Date of dispatch

- Customer’s name and address

- Dispatcher’s name and address

- Transporter’s name and address

- Product name, dosage form, content, quantity and batch number.

- Transport and storage conditions.

6.6 All records of dispatch should be retained at both sides (dispatcher and customer) and available on request.

7. Document

7.1 Operation procedures: approved operation procedures determining working method in the store should be posted at places easily readable. These procedures should accurately describe the process of reception and inspection of received drugs, storage, sanitation and maintenance of treasure, equipment used in storage (including processes of inspection and control of insects, vermin...), regulations on recording storage and safety conditions in the store and during transportation, dispensing, records including records of place orders by customers, returned products, process of recall and determining the path of products and information. These procedures should be approved, countersigned with date of approval by competent persons.

7.2 Appropriate record system should be available for recording, monitoring reception and dispatch of products including product name, batch number, expiry date, quantity, quality, supplier and manufacturer....meeting regulations of the law. In case the record system is computerized, it is ensured that regulations of the law are complied with. Specific regulations, precautions should be available to avoid illegal intrusion, use and modification of stored data.

- Reception and dispatch follow-up voucher (see attached Form No.1 GSP/MB)- Product quality follow-up voucher (see attached Form No.2 GSP/MB)

- Other forms according to regulations of relevant ministries and departments.

Reception and dispatch follow-up voucher should be made specifically for each type and specification of products.

Dispensing and receiving toxins, narcotics and psychotropic drugs should be in strict compliance with records related regulations as set out in relevant Statute.

Part 3.

GUIDANCE ON IMPLEMENTATION

1. General regulations:

1.1 Pharmaceutical manufacturers, importers, exporters, wholesalers, contractors, drug storage and conservation service companies, hospital’s pharmacy departments, Research Institute and medical centers should build a step-by-step plan for investment and construction of store according to "Good storage practices” principle.

1.2. While applying “Good manufacturing practices” principle, pharmaceutical manufacturers shall also apply “Good storage practices” principle.

2. Implementation

2.1 Training

a- The Ministry of Health (Drug administration of Vietnam) shall organize dissemination and training in “Good storage practices” to Vietnam Pharmaceutical Corporation (Vinapharm), the Services of Health of provinces and cities under the Center, branches, departments of health, pharmaceutical manufacturers, central and local hospitals.

b- The Services of Health of provinces and cities under the Center, Vinapharm, branches and departments of health should be responsible for disseminating and training principles of “Good storage practices” to entities placed directly under including hospital’s pharmacy departments, Research Institute and medical centers in the administrative division.

c- Entities themselves should expedite dissemination and training in principles of “Good storage practices” to their staff.

2.2 Registration procedures and inspection authorities

2.2.1 Inspection registration

Entities, after carrying out the inspection and evaluation on their own as having met “Good storage practices” standards, shall submit the inspection registration dossier on “Good storage practices” to the Ministry of Health (Drug Administration of Vietnam) Registration dossier consists of:

- Registration of inspection of “Good storage practices” (Attached form No.3-GSP/MB)

- Programs, subject matters and results from the training in “Good storage practices” at the establishment.

- Organization chart and payroll

- Map of geographical positions and design of stores

- Environmental assurance acknowledgement issued by competent agencies.

- List of storage facilities.

- List of stored product categories

- Minutes of self-inspection of “Good storage practices”

Registration dossier is made into 03 sets and sent to Drug Administration of Vietnam.

2.2.2 Inspection registration dossier:

Inspection registration dossier consists of:

- Registration of re-inspection of “Good storage practices”

- Reports on changes in payroll, organization, workshops of the entity during two years of implementing “Good storage practices”.

- Summary reports on programs, subject matters and results from the training in “Good storage practices” during two years.

- Reports on inspection and assessment by the entity itself in the most recent phase for the implementation of “Good storage practices”.

2.2.3 Inspection and certification authorities

Drug Administration of Vietnam shall be responsible for receiving and appraising the inspection registration dossier, formulating the Inspectorate and certifying the entity as having met “Good storage practices” standards.

2.2.3.1 Credentials of inspectors

- University degree and over, experienced in pharmaceutical management in general and pharmaceutical product storage in particular.

- Honest and objective

- Having systematical working method, strong determination in complying strictly with statutes and regulations, ability to quickly detect shortcomings and to advance convincing solutions helping entities to cope with them.

2.2.3.2 Appraisal of inspection registration dossier on “Good storage practices”

After receiving the inspection registration dossier on “Good storage practices” submitted by the entity according to the regulation (section 2.2.1 and 2.2.2), Drug administration of Vietnam shall coordinate with specialists of relevant agencies for appraisal (inclusive of appraisal record). Within 30 days since all eligible documents, Drug Administration of Vietnam shall issue a decision to establish the Inspectorate to inspect “Good storage practices” at the establishment. If the dossier fails to meet requirements, Drug Administration of Vietnam shall issue an official dispatch specifying the reason.

2.2.3.3 Inspection and certification authorities

- Participants of the Inspectorate: Drug administration of Vietnam and the Services of Health of provinces and cities under the Center where the enterprise is headquartered.

- Inspection record shall be signed for confirmation by representative of entity and head of the Inspectorate and made into three (03) copies: the entity, Drug administration of Vietnam and the Services of Health of provinces and cities under the Center each keeps one (01) copy.

After inspection, if the entity is found to have met the principle of “Good storage practices”, the Ministry of Health (Drug administration of Vietnam) shall grant the Certificate of good storage practices. The Certificate of good storage practices shall have a validity of two years since the day of signing. Three months before the Certificate becomes invalid, the entity should prepare procedures of registration for re-inspection according to Sections 2.2.2, Point 2.2, Item 2, Part III hereof. If the standards are met under the regulations, the entity shall be re-granted the Certificate.

The inspection of “Good storage practices” shall be carried out every two years unless otherwise required unexpectedly by the Ministry of Health (Drug administration of Vietnam).

 

FORM NO.1-GSP/MB

Voucher No.:.......

Name of entity

RECEPTION – DISPATCH FOLLOW-UP VOUCHER

Year.....

Store:.......

Product name (concentration, content)................Unit.................. Expiry date...

Production place................................  Packaging specifications......

Date

Explanation

Incoming quantity

Inventory of each manufacture batch

Signature

Receiving

Dispatch

Inventory

 

FORM NO.2-GSP/MB

PRODUCT QUALITY FOLLOW-UP VOUCHER

Name of managing units  

Product name (concentration, content).................................. Unit......

Production place.....

Date of product arrival

Date of inspection

Code of receiving/dispatch voucher No.  

Incoming source

Quantity, specifications

Testing voucher No..

Manufacture batch No.....

Expiry date...

Comments

Quality classification

Changes in quality of stored products (date of inspectin/quality condition)

Notes

 

FORM NO.3-GSP/MB

Name of managing units  

Name of entity

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom - Happiness

------------------------------------

.......Date..........

 

REGISTRATION OF “GOOD STORAGE PRACTICES”

To: Drug administration of Vietnam

1- Name of entity...

2- Address:......

3- Establishment Decision or operation license:...

In compliance with the Decision No..../2001/QD-BYT dated...2011 of the Minister of Health on application of “Good storage practices”, after carrying out self-inspection, our entity would like to register with the Ministry of Health (Drug administration of Vietnam) for the inspection of “Good storage practices” and undertake to overcome shortcomings stated in the inspection record.  

The following relevant documents are also enclosed:

1. Training documents of “Good storage practices”

2. Organization chart and payroll  

3. Map of geographical positions and design of stores

4. Environmental assurance acknowledgement issued by competent agencies.

5. List of storage facilities.

6- List of stored product categories

7- Minutes of self-inspection of “Good storage practices”

 

Representative of entity

(Signature, full name, stamp)

 

LIST

OF LESS PERSISTENT ACTIVE INGREDIENTS

Acid acetylsalicylic

Aminophylline

Amitriptylline hydrochloride

Ammonium chloride

Acid ascorbic (Vitamin C)

Amphotericin B

Ampicillin natri

Ampicillin trihydrate

Antimony natri tartrate

Acid undecylenic

Bacitracin

Benzathine benzylpenicillin

Benzylpencillin kali

Benzylpenicillin natri

Bephenium hydroxynaphthoate

Calcium gluconate

Calcium para-aminosalicylate

Carbenicillin natri

Cefalexin

Chloral hydrate

Chloramphenicol natri succinate

Chlorphenamine hydrogen maleate

Chlorpromazine hydrochloride

Chlortetracycline hydrochloride

Cloxacillin natri (monohydrate)

Codeine phosphate

Cholecalciferol

Dapsone

Dexamethasone natri phosphate

Dicloxacillin natri (monohydrate)

Diethylcarbamazine dihydrogen citrate Doxycycline hyclate

Emetine hydrochloride

Ephedrine

Ephedrine sulfate

Epinephrine

Epinephrine hydrogen tartrate Ergocalciferol

Ergometrine hydrogen maleate

Ergotamine maleate

Ergotamine tartrate

Ethosuximide

Ethylmorphine hydrochloride

Fluphenazine decanoate

Fluphenazine hydrochloride

Formaldehyde solution

Gentamycin sulfate

Guanetidine sulfate

Hexylresorcinols

Hydralazine hydrochloride

Hydrocortisone natri succinate

Hydroxocobalamine

Hyoscyamine sulfate

Imipramine hydrochloride

Isoprenalin hydrochloride

Isoprenaline sulfate

Quinine bisulfate

Quinine dihydrochloride

 

Lidocaine hydrochloride

 (Senna leaf)

Malarsoprol

Metrofonate

Naloxone hydrochloride

Natri calci edetate

Natri lactate

Natri nitrite

Natri para-aminosalicylate

Natri stibogluconate

Neomycin sulfate

Nystatin

Orciprenaline sulfate

Oxytetracycline hydrochloride

Phenobarbital natri

Paromomycin sulfate

Penicillamine

Pethidine hydrochloride

Phenoxymethylpenicillin

Pehnoxymethylpenicillin calci

Phenoxymethylpenicillin kali

Phentolamine mesilate

Phenybutazone

Pilocarpine hydrochloride

Pilocarpine nitrate

Procainamide hydrochloride

Procaine benzylpenicillin

Procaine hydrochloride

Procarbazine hydrochloride

Promazine hydrochloride

Promethazine hydrochloride

Pyridoxine hydrochloride

Retinal (vitamin A)

Salbutamol sulfate

Sulfacetamide natri

Sulfadiazine natri

Sulfadimidine natri

Suxamethonium chloride

Tetracaini hydrochloride

Tetracycline hydrochloride

Thiamine hydrochloride

Thiamine mononitrate

Thiopental natri

Tolbutamide

Warfarin natri

 


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Số hiệu2701/2001/QD-BYT
Cơ quan ban hành
Người ký
Ngày ban hành29/06/2001
Ngày hiệu lực14/07/2001
Ngày công báo...
Số công báo
Lĩnh vựcThương mại, Thể thao - Y tế, Xuất nhập khẩu
Tình trạng hiệu lựcHết hiệu lực 10/01/2019
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Lược đồ Decision No. 2701/2001/QD-BYT application of good storage practices principle


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          Decision No. 2701/2001/QD-BYT application of good storage practices principle
          Loại văn bảnQuyết định
          Số hiệu2701/2001/QD-BYT
          Cơ quan ban hànhBộ Y tế
          Người kýLê Văn Truyền
          Ngày ban hành29/06/2001
          Ngày hiệu lực14/07/2001
          Ngày công báo...
          Số công báo
          Lĩnh vựcThương mại, Thể thao - Y tế, Xuất nhập khẩu
          Tình trạng hiệu lựcHết hiệu lực 10/01/2019
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                Văn bản gốc Decision No. 2701/2001/QD-BYT application of good storage practices principle

                Lịch sử hiệu lực Decision No. 2701/2001/QD-BYT application of good storage practices principle