Pursuant to the law No. 34/2005/QH11 Pharmacy on June 14, 2005;

Pursuant to Decree No. 79/2006/ND-CP dated 9 August 2006 from the Government detailing the implementation of a number of articles of the law on Pharmaceuticals;

Pursuant to Decree No. 188/2007/ND-CP on December 27, 2007 of the Government functions, tasks, powers and organizational structure of the Ministry of health;

Pursuant Resolution 62/NQ-CP on December 17, 2010 of the Government on the simplification of administrative procedures in the scope of the management function of the Ministry of health;

Consider the situation of implementation practices principles, standards of "good manufacturing practice" as recommended by the World Health Organization in the production of drugs from medicinal herbs;

The Ministry of health regulation in principle produce the drug from medicinal herbs and routes apply principles, standards of good manufacturing practice (GMP) for the manufacturing of medicines from medicinal herbs as follows: chapter I GENERAL PROVISIONS article 1. Scope 1. This circular stipulates in principle produce the drug from medicinal herbs and routes apply principles, standards of good manufacturing practice (GMP) for the manufacturing of medicines from medicinal herbs.

2. This circular guide on the profile, the order of evaluation of condition of production of medicines from medicinal herbs in the drug manufacturing facility from medicinal herbs.

Article 2. Explain the term In this circular, the terms below are interpreted as follows: 1. The facility manufactures the pills from pharmaceutical chemicals including enterprises, households and business operating under the enterprise law to produce the drug from medicinal herbs or cooperatives and other institutions that perform activities related to the production of medicines from medicinal herbs (in this circular as the basis).

2. Drugs from pharmaceutical drug is produced from raw materials of natural origin from animals, plants or minerals.

The drug has a pure active substances extracted from medicinal herbs, medicinal combination medications with no synthetic chemicals called the drug from medicinal herbs.

3. Oriental medicine is medicine from medicinal herbs, are manufactured according to the reasoning and methods of traditional medicine of the Eastern countries.

Chapter II PRINCIPLES for the PRODUCTION of MEDICINAL DRUGS FROM article 3. Regulation of medicinal quality 1. All the pharmaceutical production of drugs for people who have to be inspected, only when quality standards and in accordance with the relevant provisions of the new law was put into production, mixing and circulation.

2. Pharmaceutical chemicals used to produce drugs must be provided by the facility are eligible drug business.

a) buying medicinal herbs from sources planted in the country must have a contract with base/personal work organization cultivating medicinal herbs, including terms to ensure the quality of medicinal herbs prescribed.

b) production facilities must record and store information on the supply, origin, method of harvesting, processing and preservation of pharmaceutical drug production.

3. Quality control of medicinal raw materials a) all medicinal herbs and raw material used in the production process must have quality standards. The facility is staffed and qualified personnel have adequate equipment to perform the sampling, inspection and testing, medicinal intermediate products, semi-finished products and finished products.

b) must be available the medicinal form reference to use in the comparison test: test by sensory, microscope, and by different chemical methods. The sampling of intermediate products, medicinal products, and the products must be made according to the procedures that have been approved by the facility and by the individuals who have the expertise and experience of pharmaceutical performed.

c) need the profile notes, to prove that all the process of sampling, checking and necessary testing has really been done in the process, and any discrepancies would compared to processes are fully documented on the record.

d) Must record the test results and tested according to standards for the medicinal herbs, raw materials, intermediate products, semi-finished products and finished products. Need to keep sufficient amount of samples of medicinal herbs, raw materials, semi-finished and finished products for each production batch.

Article 4. Regulations on personnel and training 1. The facility must have sufficient qualified staff to perform the work in the scope of responsibility of the manufacturer. Must clearly define personal responsibility, this responsibility must be the individuals involved understand and are recorded in a job description of the facility.

2. Personnel a) basis must have sufficient qualified staff and appropriate experience for the manufactured part and match the scale of production at the facility. The clear separation of personnel in manufacturing, testing and storage.

b) personnel must be trained expertise and practical experience in the manufacture of drugs and medicines from medicinal herbs.

c) in charge of the manufacturing, quality control, preservation repository must have the knowledge, expertise and professional training.

3. training a) production base to organize training according to a written program for all personnel whose task in the production department, quality control, storage (including the staff do technical, maintenance and cleaning) and the other staff if needed.

b) basis must have periodic training programs, annually approved by the authorized person in the facility and to keep records of the training.

Article 5. Regulations on factories, equipment 1. The base factory must be located, designed, build, repair and maintenance in accordance with the operation in the production process and in accordance with the scale of production at the facility.

2. conservation area a) conservation area is wide enough, to fit the scale of production, there is segregation and isolation match for raw material, packaging materials, intermediate products, semi-finished and finished products, special products, products have allowed factory, removed , returned or withdrawn product.

b) conservation areas must be designed or adjusted to ensure good preservation conditions, prevent the entry of insects, rodents and other animals, must take measures to prevent the possibility of the spread of microorganisms according to the same pharmaceutical and preventing cross-contamination. Conservation area is clean, dry, and light enough to maintain proper temperatures with the object of preserving or according to manufacturer's instructions. Need to have enough tools or equipment to track temperature, humidity and must have daily tracking records.

c) To the layout area dedicated to preserving substances that require special preservation such as solvents, inflammable materials, explosives, toxic chemicals and similar substances.

d) The medicinal herbs must be preserved in the private sector, ensuring a dry and cooler air was good, got control of the temperature and humidity, are arranged systematically, have labeled. Before entering the warehouse, medicinal herbs must be inspected sensory surfaces and humidity along the relevant norms. Must have a track record and periodically check the recording process, type and inventory. For maintenance, higher refractive index extracts or other product types subject to appropriate conditions of temperature, humidity and light; These conditions must be maintained and monitored throughout the process of preservation.

DD) To build and apply label status tracking system of raw material, semi-finished products and finished products which have different label types for distinction, accepted and removed with the necessary information such as: name, batch number, test number, date of export/remove or test date/expiration date. The medicinal herbs are removed should be clearly labeled indicating the status and preserved, separate from the medicinal herbs are acceptable. Only those who have the responsibility for quality control is assigned to the new tagged determine the status of the initial material.   

3. The area of preliminary processing, handling and processing of medicinal herbs a) must have separate areas for handling, processing and processing of medicinal herbs, this Department is separate from the other drug production areas. The medicinal preparation area as: do the essential cleaning and removing impurities, sandy soil, the parts not used to; wash; cut; dried and processed medicinal (pharmaceutical washing place, drying or drying medicinal herbs as requested and the scale of the facility).

b) area, processing of medicinal herbs to ease sanitary, ventilation, ensure safety and convenient operation, have clean water system the minimum drinking water standard is to process medicinal herbs to ensure hygiene standards.

4. The manufacturing sector a) workshops must have appropriate location, not contaminated, designed, ensuring convenient operation, maintenance and cleaning of the suit, to avoid the adverse effects of the weather. Buildings must be designed, arranged the production rooms ensure the principle of direct current for the shipping of raw materials, personnel, waste products, and aims to prevent the products can be mixed and/or cross-infection or when production operations have born dust.

b) production factories are built, maintenance and protection against the insects, animal gậm rodents and other animals penetrate and nest.

c) workshops must have lighting systems are designed and installed to fully ensure the work being conducted correctly. To ensure a neat, clean, maintenance, maintenance in good condition and must be clean and disinfect according to the processes in detail, in writing, to keep records of sanitation process for each production batch.

5. a quality control area) the area tested, quality control of drugs must be separated from production areas. Quality control rooms must be designed in accordance with the operation will proceed in that area and must be wide enough to avoid confusion, cross infection, and enough to preserve the template, standard substances, solvents, reagents and test records.

b) area to conduct biological, microbiological tests must be separated from each other and have to have separate air handling equipment and other devices.

6. auxiliary system a) air treatment systems


Encourage the investment facility installed air conditioning systems or automatic separating for the manufacturing sector such as: manufacture, testing, maintenance, microbiological testing area, production area of sensitive substances, toxicity.

b) water treatment system depending on the requirements of each dosage form of drugs, the source of water used for production purposes must meet the minimum standards of the drinking water is or must meet the standards of water use match the requirements of each dosage form drugs.

Encourage investment base to build water treatment systems for water-level standards for the manufacturing of drugs. The annual sampling plan done right, check out the quality of the source water in the production process.

c) wastewater treatment system, waste gas and waste facility must have waste water treatment measures, emissions and process the waste substance, proper scrap in production process, ensure safety and hygiene.

Encourage investment base to build waste water treatment system, waste substances, wastes, consistent with the scale of production at the facility, ensure safety and hygiene.

d) system of fire base is equipped with sufficient tools, fire equipment, fire and have the fire fire fire protection agency approval; The equipment, fire appliances are maintained.

7. a) production equipment manufacturer must be equipped with the necessary equipment suitable for the production of drug items were manufactured at the facility.

b) production equipment must be designed, built, selection, layout and installation and maintenance of suitable guarantees convenient, safe to operate, easy to cleaning and maintenance; ensure cross-infection, avoid the accumulation of dust and dirt, to avoid the adverse impacts that affect product quality.

c) weight and measuring equipment must be calibrated according to the regulations. The calibration, and evaluation must be conducted in full and the calibration results must be recorded and stored.

d) must have the processes guide the cleaning and maintenance of the equipment, instruments and ensure the processes are in full compliance.

DD) Air and equipment damage, do not use need to be moved out of the area of production and quality control. If there turn out to be, must be marked or labeled clearly is already broken, unintentionally used.

8. The area weight The weight of the initial raw materials needed in the separate scales are designed for weighing purposes. This area may be located in the area of preservation or production areas.

9. The area of hygiene personal hygiene area and Foyer are separate from the manufacturing areas or drug testing. Change rooms and keep clothes, bathing and hygiene areas are easily accessible and in accordance with the number of users. Toilet not be passed directly to the area of production and storage of drugs.

Article 6. Regulation on hygiene and sanitation 1. The facility must implement the principles ensuring hygiene and personal hygiene throughout the production process, including the factory hygiene, personal hygiene, hygiene, equipment and machine tools, packaging materials, packaging.

2. Standards the basis to formulate and enact standards for the inspection of hygiene in production; Standards of work attire; How to check the health condition of employees; Hand washing and antiseptic way.

3. factory housekeeping a) basis to build process and factory hygiene methods and equipment that suit the requirements of each dosage form drugs. This process must be periodically reviewed and approved by a competent person at the facility.

b) Must take measures to regular processing waste from manufacturing to ensure hygiene for this area, waste containers must be clearly marked, is poured and regular hygiene, minimum 1 day 7 times.

4. personal hygiene a) employees work in the production department must be training, training on practice to ensure the hygiene conditions of factories, equipment, appliances, and personal hygiene.

b) basis to take measures to ensure that employees comply with the rules of personal hygiene consistent with the requirements of production and properties of dosage form drugs.

c) operating air staff was not in direct contact with the hand on the original raw materials, packaging materials, intermediate products and finished products for sale.

d) staff must be equipped with the instruments proper labor protection such as gloves, hat and protective clothing, masks, shoes, slippers fit for each stage of production, processing. Need to take measures to protect the staff avoid direct exposure to the toxic substances, medicinal herbs have the ability to cause allergies.

DD) are not allowed to smoke, eat and drink, to fresh plant food, beverages, medicines and other personal belongings in the area of production, quality inspection and preservation areas, or in other areas that can cause adverse effects to product quality.

Article 7. Regulations on the document profile 1. The facility must establish the profile system documentation to determine the criteria and processes for all raw materials, finished products and determine the method of production as well as quality control; to ensure all employees are related to the production of both understand and perform the right tasks assigned; make sure the person is authorized to have all the necessary information when deciding to export a batch of the drug to the market; and make sure you have the evidence on the record, can find and provide for the inspection of these records as well as clues to the investigation. Document profile make sure you have the necessary data for the evaluation, review and analysis of statistics.

2. Label a) Labels for packaging, machines, equipment or plant must be clear, not blurred and shark is a common form of compliance with the provisions on labelling of drugs. Next to the words written on the label, can use color to indicate the condition of the raw materials, machinery, equipment (for example are distinct, has been accepted, rejected or clean).

b) all smoking products are to be identified and labeled according to the current rules on the labeling of the drug.

c) for standard substances, label and/or accompanying documents must specify the active force or the concentration, date of production, the expiry date, the date of opening the packaging first, conditions for storage and control number if available.

3. Records of the quality standards of the original raw materials, intermediate products, semi-finished products, finished products must have adequate standards and analytical methods, testing. The original material must be consistent with the standards of Vietnam, Pharmacopoeia standards and regulations for quality and hygiene in accordance with the Ministry of health.

a) standards for raw materials and packaging materials standards for raw materials, primary packaging original packaging printing and if appropriate the need for raw materials, description of which must have the following information:-the name is placed (if possible outlined both the name of the INN) and the internal code. For medicinal herbs must have the minimum information as name and origin (medicinal name, scientific name, the section is used), the sensory description.

-Reference to treatise of the pharmacopoeia.

-The qualitative requirements and quantitative limits allow.

Depending on the requirements of the base standard, there may be additional information, such as: the supplier and manufacturer of original materials, packaging printing templates, guides and sampling testing, or reference to procedures performed, the conditions of preservation and the careful preservation of the maximum time limit, before testing again , expires.

Packaging materials directly with the drug are prescribed standards of Vietnam Pharmacopoeia and are compatible with the materials and/or products contained therein. Raw materials are checked on quality standards, the damage and the accuracy of the identification sign.

The records document the testing process description must specify the frequency prescribed for weighing in again each original material, depending on the longevity of them.

b) standards for intermediate products and semi-finished products must have a record of standards for intermediate products and semi-finished products. If that product is purchased or delivered, or if the data are obtained from the intermediate product was used to evaluate the product. The criteria are similar to the standard initial raw material or finished product, if appropriate.

c) finished products standards products standard must have the key information such as product name and code references if available; Component name/active ingredient; The formula or the formula reference; Description of dosage and details of packaging; Guide to sampling and testing, or reference to procedures performed; Qualitative requirements and quantitative limits; Preservation conditions and caution if any; Term of use.

Finished product standards must be the test for the active ingredient can be quantitative and qualitative tests in quality control of finished products. Need to have the test determines the limit allowed by the residual nature of the substances used to preserve, washing (if any), and whether to participate in the process of processing of medicinal herbs.

In addition to have the test for the other relevant criteria according to each requirement of each dosage form, such as: external form like color, flavor, size and texture; Uniform volume levels, hardness, disintegration time (for tablets), in, viscosity (for the solution), the uniform (for ointments, lotions); Mass loss due to drying or water content; Bacterial levels, v/v.

4. Record the original recipe


The facility is built to the original formula was approved officially for each product and each production batch size. The original recipe required information: name of the product, the product's reference code relating to standard; Description of the dosage form, batch size, and content; List of original material is used (the name INN if available), the amount of each substance, described by name and refer to the type of material that (need to specify the substance would be lost in the process of processing); Announced products and expected output limits allow, and output of intermediate products, if any; Stated location of processing and equipment mainly used; The reference method, or methods, are used to prepare and operate the critical equipment, such as for cleaning (especially after changing products), installation, calibration, sterile,; Detailed processing instructions turn step by step (for example, test materials, preliminary processing, sequence of adding materials, mixing times, temperatures); Guidelines for the examination of the manufacturing process and the corresponding limit; If necessary, the rules on the preservation of the product, including packaging, labels and special preservation conditions; the need is especially cautious when produced.

5. processing instruction records lot a) must set records for each batch produced, which specify: the name, the concentration, the concentration of the product; Date of production; The batch number, batch; The full recipe of lot/batch; The SOP is used and record each stage was conducted, all the main equipment is used, all the samples, test results in the production process, the test results of environmental conditions, check the equipment before the start and during the production process, Pack and store the sample label on the packaging.

b) Must keep records for each batch processing a batch production. Records need to be based on the relevant section in the original standard has been approved. The method of preparation of records should be designed to avoid these errors. (Should copy again or use the computer programs have been appraised. Should avoid copying manually with the approved document).

c) must set the processing guide which lists the various operations conducted on medicinal herbs, such as dried, and finely ground, should also stated the temperature and the time required for the drying process, and the method used to test the pieces or the size of the U.S. segment.

d) Should give guidance on screening or other methods used to remove impurities. To detailed any processes would, for example, the sauna is used to reduce microbial infection, along with the method of determining the extent of this pollution.

For the production of preparations from medicinal herbs, the instructions must clearly indicate the substance, or the solvent used, time and temperature must be guaranteed during the extraction process, and whatever method she would.

The guidelines should specify the steps in the process of mixing and adjusting to reach levels of active medicinal ingredients and ensure the uniformity of the plot after mixing the same provisions on the recording parameters in the mixing process.

To build measures to eliminate the pharmaceutical after processing if not standard quality. 

DD) with respect to the period of production of finished products, must have for all raw materials used; all the standard operation procedures; each batch and/or each batch processing and distribution; all the equipment, including the operation, maintenance, housekeeping and appraisal; and for hygiene, environmental control and maintenance of production areas.

All the records must specify the time and be signed by the person responsible for conducting the work, for the important operation, a must have both the signature of the supervisor and must be kept at the place of work during the entire process the operation. Records must be kept and available for inspection for at least 2 years after the expiration of the batch of drugs.

6. process and profile records must have the standard operation procedure guide the production, cleaning and maintenance of equipment, production tools, which specify: assigning responsibility for cleaning; the schedule determines the sanitation, maintenance of equipment; the method of conduct; the equipment and materials used; maintenance instructions the equipment was clean from contamination and hygiene; hygiene condition control device before use. This process must be in full compliance.

Article 8. Rules on the production and control of the production process 1. The facility must ensure the manufacturing operation is performed according to the procedure already registered in the production and circulation of drugs.

2. Raw materials a) original material all the original ingredients or raw materials used in the production process must have quality standards and must be checked, tested quality. The basis must prepare the import, export, inventory records, the status of inventories of raw materials, semi-finished products.

The processing of raw materials and products, such as receiving and storage differences, sampling, storage, labelling, allocate, processing, packing, and distribution of all must follow proper procedures or instructions in writing and recorded if necessary.

For the raw materials of animal origin are recorded details about the supply, origin, method of production in the profile. This material should be preserved in the condition control and specify limits on use or testing.

Raw materials and discarded products should be clearly labeled indicating the status and preserved separately in limited areas. The discarded materials must be stored securely and separately from the raw materials are accepted.

The basis to build and perform inventory turnaround programs according to the principles of the previous expiration-export (FEFO) and enter before-previous (FIFO).

b) packaged raw materials purchasing, management, check the packaging material and packaging direct in available must be made as to the original material.

The packing material, printed packaging must be stored in a limited access area and allocated under strict supervision.

c) intermediate products and semi-finished products and semi-finished products waiting to be special packaging store to check the quality before you proceed to the next phase.

All the intermediate product manufacturing and semi-finished products including the additional appearances at the request of the production must have full documentation.

If the ingredients/raw materials are transformed into new packaging, new packaging must be identified with a label that reads: the name or code of the component/material, receiving code or the code volume control in new packaging. Distribution operations/export additions must be full, monitoring each component/material must be checked by a second person to ensure that:-ingredients/raw materials have allowed output for use by the quality control Department.

-The correct volume according to the output command-The containers are defined properly.

d) provisions on sampling Have rules about labelling specify packaging material, containers are sampled. Must have the following information for each template is retrieved: name of the person taking the sample, the number of samples taken, the number of containers on template sampling.

The original materials must be stored until differences are accepted and permitted use.

3. a production process), batch numbering system.

The system describes the details of the lot numbering, including the identification of initial raw materials, packaging materials, intermediate production, semi-finished and finished products.

The batch number, batch must be recorded immediately and must include the following information: the date of grant, identity of product and lot size,.

b) weight and balance area allocated must be equipped to prevent cross-infection and be separated mechanically with the other rooms by wall or other barrier types.

Before conducting weight, allocate to conduct testing of sanitary environmental conditions, temperature, humidity to ensure regional balance, allocate are clean and the weight, allocations are made correctly. The sterile materials must be balance and allocate in the sterile area. Staff must wear proper attire.

To have the measure of caution to avoid cross-contamination during the loss. To build the control to manage the allocated initial raw materials, intermediate products and finished products for sale.

c) production Must arrange production employees fit and must have appropriate measures to monitor all of the processing operation. The staff must wear appropriate attire to proceed with the processing operation.

Environment and production conditions are met according to the rules. All the equipment must be checked before use. The equipment weight, measurement and calibration must be have a precision fit with the material needed weight, swung.

To have preliminary procedures, handling of medicinal herbs. When processing medicinal herbs to pay attention so that the processing does not affect the quality of medicinal herbs.

During processing, all materials, semi-finished products, packaging the correct equipment, and if both the room and packing are used must be tagged or if not should have the identifier names of products or materials are to be processed , the concentration (if appropriate), and the batch number. All the trademarks and inappropriate signs were there before the processing must be completely removed.

The press members do not have separate sealed environment must be placed in separate areas. The experiment on the weight and hardness of the members must be conducted in the stamping process.

For production of capsules, capsule weight should conduct throughout the process to close. The tablets or capsules taken directly from the injected parts, close to testing follicle or used for other purposes must be collected and destroyed properly.

The empty capsule shell must be preserved in the condition to avoid dryness and cracking or avoid the effects of moisture.

The ink used in the capsules and capsules to the food coloring and be considered as raw materials.


The liquids or creams and ointments are produced by the method and conditions avoiding the contamination of bacteria and other pollution types. The production, the transport of liquid or cream, powders must be made in the closed system.

d) intermediate products and finished products must have special storage system and export warehouse for semi-finished and finished products, including defining clearly the status of the product (store, factory, removed). To build the system and procedures for the handling of the product is not reached and the product being returned.

DD) control in the production process Needed to conduct the inspection, control and record all test results in the manufacturing process and control the environment according to the production process and batch records.

4. Labelling, packaging and distribution of a) the packaging must have the standard packaging and packaging direct in available. Must have the SOP for the activities of receiving, sampling, packaging material testing.

b) active labelling and packaging The packaging and labeling activities must be separated mechanically to avoid confusion of the product and the packaging. The label template and a sample of the packaging has been printing must be saved in the record batch. There are special areas separate and secure storage for the finished product waiting for permission.

c) preservation and distribution Must build the SOP for the preservation of finished products shipped in shipping area. Must have the profile allows for the quick identification of all the customers who have purchased the product a lot/batch determines which specify the time, quantity, packing and shipping of each batch of product for the customer.

 Need to store the notes on storage time, temperature and other preservation conditions prior to delivery.

5. Hygiene in production must take measures to control the use of insecticides to avoid the contamination of the product. Waste water, waste, the material was abandoned, not accepted must be controlled and/or treated in a manner that is safe, hygienic. To the regulations of the staff at limited areas.

Article 9. Regulations on quality control 1. Drug manufacturing facility from medicinal herbs must perform testing each batch of drugs, only to reach the quality standards of new registered factory.

2. Production of medicines from medicinal herbs are invested to build and test parts of drug testing and drug materials consistent with the scale of production at the facility. Quality control Division is independent of other parts and administered by a person who has the qualifications and experience fit, this person can run one or more of the laboratory. It should have sufficient resources to ensure that all measures of quality control are performed in an efficient and reliable.

3. for the production of medicines from medicinal herbs have not established drug testing parts or have established drug testing parts but not yet tested all the quality criteria must then send the form and signed drug testing with the unit are eligible and there are function tested drugs to perform the testing for each batch of drugs produce at the facility or to test for the quality targets unrealized at the base. The vote tested must be stored in the profile of each batch of drugs.

4. quality control personnel personnel of the quality control Department must have deep expertise on products from pharmaceutical drugs to conduct qualitative test, check for the fake, the presence of mold, insect, or inconsistency of the plot. Quality control Division must have sufficient trained staff, the expertise and experience to get the job done.

5. The equipment of a Room or parts) check the quality must be consistent, to ensure enough room for professional tools, equipment, records and document workspaces for employees.

b) quality control Rooms must be equipped with the machines, equipment and instruments suitable for the sampling, analysis, calibration and data processing. The analysis must match the method tested and must meet the requirements of quality inspection units. Physicochemical test rooms equipped with test equipment indicators physicochemical (drying, kiln, test machine, thin layer chromatography, Kublai Khan, ...) and the control equipment in the production process. With regard to the norms have to use expensive equipment such as gas chromatography or the test difficult to implement as the infection can base level through the service unit to the test. The test results must be kept to track long-term.

6. Records, document a) laboratory to have the manual testing, record analysis, the test votes, polling analysis.

The manual testing staff recorded the results, data, calculations, and the comment is relevant to the analysis of a sample. Window must be numbered pages and do not use pencil to take notes, not erasing, overwrite.

b) profile analysis must have full information about the sample, test method, results analysis and must be printed with the following minimum information: Model Name, origin, place of production, reference code if available; Batch number, expiration, requirements analysis (number, date and content); On receipt of the form, the person receiving the form; Standards and testing methods; Upon receipt of the form and status before analysis; Results analysis (including calculation); Analysis records must be saved to the profile tested along with the results of the analysis. Analysis of votes must be signed by testing and monitoring.

c) to update and retain all the quality standards required for the work of testing, including: Vietnam Pharmacopeia and the foreign Pharmacopoeia, including appendices, a supplement and a vetted; Quality standards without Pharmacopeia in, for those drugs be tested based on the standards of the manufacturer. The methods tested without Pharmacopeia in the do laboratory research, issued.

7. track stability facility to build process and establish stability track record of the drugs produced. The track record of stability of medicines must be kept.

Article 10. Regulations on complaints and product recall at the base 1. Complaints about the product base to build the writing process to handle all the issues of the complaint with respect to the product and specify who is responsible, forward, review and reviews complaints about products production base. The handling of the complaint products must be recorded in writing and stored in the time according to the expiry date of the batches of the medicine were complaining.

2. products returned the base to set the track record and the construction process in writing to receive and inspect the returned product. The profile of the products being returned are stored content including: name and amount of the product, the dosage, lot number, reason for return, the quality of the product returned, the returned date. The products returned must be clearly identified and preserved in the quarantine area.

3. Withdraw the product base to build the writing process to handle the recovery products and Regulation Authority decided to recall a product. Must establish and keep records and report on recovery products including the results of the recovery of the product and the action blocked. The products recovered are preserved in a safe place to avoid the products recovered on re-circulation, use that has not conducted investigations, reviews.

Article 11. Rules of automatic inspection activities at the facility the facility to build the self inspection activity plan and identify suitable inspection team members. To record the self inspection and reporting inspection order to take the appropriate corrective action.

Chapter III PROFILE, sequence PRODUCTION CONDITION ASSESSMENT of MEDICINES FROM PHARMACEUTICAL CHEMICALS article 12. Records suggest that drug production condition assessment and certification of qualified business smoking 1. Recommended records appraisal conditions produce the drug from medicinal herbs and certification of eligible drug business, including: a) petition evaluation and certification of eligible drug business (form No. 1);

b) copy of certificate of pharmacy practice managers specializing in medicinal form suits organizes drug business; a copy of the business registration certificate.

c) affidavit a list of personnel, equipment, expertise, technical infrastructure-personnel list declaration and description of functions (form No. 3)-organizational chart relating directly to the drug production process.

-The category of the equipment, machinery, material and technical base of service production, testing, storage-equipment layout, the main production tool and machine-overall map production and the direction of movement of the staff, raw materials, packaging.

-Storage warehouse diagram 2. Records suggest the business scope and additional certification of eligible drug business, including: a) additional appraisal form trading range (form No. 2);

b) copy of certificate of eligibility issued drug business;

3. The records suggest the extension of the certificate of eligible drug business prescribed in article 15 paragraph 3 of this circular.

Petition to renew the certificate of eligible drug business must have the following information: name address of the facility; full name of the professional managers of pharmacy, pharmaceutical practice certificate number; dosage of drugs suggest renewed (stating the dosage), the number of the certificate of eligibility issued drug business, on the level and the place.

4. Basis of preparation 01 record suggest drug production condition assessment and certification of qualified drug production sent to the Ministry of health (pharmaceutical Management Bureau) or the Department of health of the province of the central cities, as stipulated in article 14 of this circular. The profile must be played into the (volume) sure, there's the cover and are arranged in the order as follows: the cover (4); Index profile (model No. 5); The next page sorted as categories of records.


5. The copy of the profile is a certified official copies in accordance with the current rules about endorsements or is a copy of the original by the Medical Director of the facility certification and seal the base responsible before the law about the authenticity of the copies are in the profile.

Article 13. The order of evaluation of condition of production of medicines from medicinal herbs and certification of qualified business smoking 1. Within 20 working days from the date of receiving documents, the Ministry of health (pharmaceutical Management Bureau) or the Department of health is organized founded mission conditions of production at the facility; If not held due diligence was, within 10 days from the receipt of the record, must respond in writing and stating the reason.

2. At the time of the evaluation of the condition of drug production, the production base to conduct the activities of production, quality control, maintenance of the new establishments (register first, production operations can be conducted on samples of confronting (the placebo sample) evaluation group to assess conditions in the production of drugs under the principle of the production of medicines from medicinal herbs are instructions in chapter II in This circular.

3. Mission established a production condition assessment of medicines from medicinal herbs according to the model No. 6. Report on the evaluation of established 3 a, 2 a save at the agency evaluation organizations, 29 a save at the facility. Report on the appraisal must specify the conclusion about the status (Professional, wire form production) have met, have yet to meet or not meet the principles of the production of medicines from medicinal herbs according to the provisions of the circular. In the case of establishments not agreed with the opinion of the mission, the minutes must specify all of the reserves of the base.

4. The base case production has met the principles of producing the drug as defined in chapter II of this circular, within 20 working days from the date of conducting the evaluation conditions produce the drug in the base, the Ministry of health or the Department of health must be certified eligible for business premises If no level must reply in writing and stating the reason.

5. in case of production facilities do not meet or do not meet the principles of producing the drug from medicinal herbs, in the minutes of the appraisal must specify the reasons and remedies for repair. Within 60 days of evaluation, facilities must conduct the repair remedy according to the requirements of the mission, and filed reports to fix (attached to the documents) about drug administration or the Department of health. Based on the report of remedy, within 10 working days from the date of receiving the report of remedy, the Ministry of health or the Department of health must be certified eligible for business premises, if not granted, must be answered in writing and stating the reason.

6. within 90 days prior to the time the certificate of eligibility expired drugs business, the facility must conduct evaluation proposal submission back conditions produce the drug from medicinal herbs to the Ministry of Health/Department of health arrange time evaluation.

7. Basis be responsible appraisal valuation fees filing conditions produce the drug from medicinal herbs according to the current rules on fees and charges of the Ministry of finance.

Article 14. Authorities, additional, extend, replace, change the certificate of eligible drug business.

1. The authority granted, additional, renewal, reissuance of certificates of eligibility for the business type of business has to be directed in paragraph 3 article 11 of law and pharmacy.

2. for types of medicinal drugs from production, authorities, additional, extend, replace the certificate of eligible drug business are defined as follows: a) the Department of health, the central cities of the level, additional, extend, replace the certificate of eligible drug business for the production of medicines from pharmaceutical business registry cooperative; only use medication production enterprise apart from medicinal herbs; manufacturing, processing and packaging of medicinal herbs.

b) Ministry of health level, additional, extend, replace the certificate of eligible drug business for enterprises producing medicines from medicinal herbs and other cases except in the cases specified in point a of paragraph 2 of this.

Chapter IV PRINCIPLES APPLY ROADMAP, standard DRUG GOOD MANUFACTURING PRACTICES (GMP) for the MANUFACTURING of MEDICINES FROM MEDICINAL HERBS article 15. Deployment roadmap that applies principles, standard "drug good manufacturing practices (GMP) for the manufacturing of medicines from pharmaceutical chemicals 1. Since the day this circular effect, the basis of the production of medicinal drugs from the new establishment, additional trading range, or renew the certificate of eligible drug business must meet the principles of producing the drug prescribed in chapter II of this circular.

2. Production of medicines from medicinal herbs are allowed to drug business but have done the appraisal conditions produced by the decision No. 15/2008/QD-BYT on 21/4/2008 of the Ministry of health is continuing to operate until the end of the validity of the certificate of eligible drug business but not too on 31/12/2012.

 3. Production of medicines from medicinal herbs have been appraised production conditions by decision No. 15/2008/QD-BYT on 21/4/2008 of the Ministry of health and is certified eligible drug business in force until 31/12/2010 be considered renewed or issued a certificate of eligibility to the drug business ended on 31/12/2013. Extended review procedures certificate of eligible drug business are prescribed in paragraph 3 article 12 of this circular.

4. From the date of 01/01/2014, the production base of drugs from medicinal herbs must meet guidelines, good manufacturing practices standard medications as recommended by the World Health Organization (WHO-GMP) new eligible drug business. The case of the production of medicines from pharmaceutical business registry if not yet meet guidelines, good manufacturing practices standard drugs must comply with the principle of the production of medicines from medicinal herbs prescribed in this circular and only consider the license production of the Oriental medicine and periodically, 12 times to reevaluate the drug production conditions.

5. The base roadmap implementation guidelines, good manufacturing practice standards and principles in the production of medicinal drugs from the provisions of this circular, Drug Administration Guide and the basis of the renewal procedure of registration of medicines from medicinal effect to 31/12/2010 for drug production.

Chapter V IMPLEMENTATION article 16. Transitional provisions 1. The basis of the production of medicines from medicinal herbs have been appraised production conditions by decision No. 15/2008/QD-BYT on 21/4/2008 of the Ministry of health and is certified eligible drug business in force after 31/12/2010 are allowed to continue trading until the end of the validity of the certificate of eligible drug business but not too on 31/12/ 2013.2. Before 1/1/2014, the qualified certificate drug business new levels, addition or extension for the production of medicines from the pharmacy does not meet guidelines, standards of good manufacturing practice (GMP-WHO) is valid only until 31/12/2013.

3. Within the time limit from the date of 01/01/2011 to this circular effect, the production base of drugs from medicinal herbs are certified eligible drug business in force until 31/12/2010 was to maintain the drug business activities in accordance with the conditions and scope of the drug business has been granted at the certificate of eligible drug business.

Article 17. Regulations on reporting drug manufacturing facility from medicinal herbs must report on Drug Administration-Ministry of health situation produced monthly medications by electronic file form (form No. 7) to the following e-mail address: qlkdd@dav.gov.vn before the day of the month; report 6, in writing (electronic attachments) before July 10, and both report the year before October 1 of the following year.

Article 18. Effect 1. This circular effect since February 8, 2011. Deregulation at the point h paragraph 1 article 1 decision No 27/2007/QD-BYT on 19/4/2007 of the Ministry of Health issued a deployment roadmap that applies principles, standard "drug good manufacturing practices" and the "good practice guidelines for preservation of smoking".

2. During the implementation process, if there are difficulties, obstacles and suggest the Unit reports to the Ministry of health (pharmaceutical Management Department) to look at the instructions./.