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Decision 15/2008/qd-Byt: Temporary Regulations Issued Basic Guidelines For The Production Of Medicinal Drugs From The Stage To The 31/12/2010

Original Language Title: Quyết định 15/2008/QĐ-BYT: Ban hành Quy định tạm thời nguyên tắc cơ bản để sản xuất thuốc từ dược liệu giai đoạn tới 31/12/2010

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The DECISION, issued temporary regulations the basic principles for the production of medicinal drugs from the period to December 31, 2010 the MINISTER of health pursuant to the law No. 34/2005/QH11 Pharmacy on June 14, 2005;
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 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 decision No. 108/2002/QD-TTg dated 15 September 8, 2002 by the Prime Minister on the approval of the "Pharmaceutical industry development strategy phase to 2010";
Consider the situation a deployment practices the principle of "good manufacturing practice" as recommended by the World Health Organization in the production facilities, sales of drugs from medicinal herbs;
Proposal of the Director of the drug administration, decision: article 1. Attached to this interim regulation decision principles fundamental to the production of medicinal drugs from the stage to the 31/12/2010 (hereinafter referred to as the regulation on the production of medicines from medicinal herbs). This policy is built on the basis of principles, standards of "good manufacturing practice" as recommended by the World Health Organization.
Article 2. In the period before 31/12/2010, the production base of drugs from medicinal herbs to meet the guidelines in the regulations on the production of new medicinal drugs from eligible activities. Encourage the production of drugs from pharmaceutical application deployment guidelines, standards of "good manufacturing practice" as recommended by the World Health Organization.
Article 3. Affairs Director of the drug administration to base regulation on the production of medicines from the pharmacy building and issued "the checklist of conditions producing medicines derived from medicinal herbs" as a basis to test yourself and check the condition of the production of the drug manufacturing facility from pharmaceutical phase until 31/12/2010.
Article 4. This decision takes effect 15 days from the Post Gazette.
Article 5. The Office of the Chief Justice, the Chief Inspector, Chief, Bureau of drug administration, heads of subdivisions, Director of the provincial health department, central cities, the health sector is responsible for the implementation of this decision.
TEMPORARY PROVISIONS basic principles to the production of medicinal drugs from the stage to the 31/12/2010 (attached to decision số15/2008/QD-BYT on April 21, 2008) i. Glossary: definitions outlined below apply to the terms used in this temporary regulations pursuant to the Guide to good manufacturing practice of drugs as recommended by medical organizations World International.
Medications from pharmaceutical Drugs from pharmaceutical drug is produced from raw materials of natural origin from animals, plants or minerals.
The lot is a definite amount of original material, packaging, raw materials or products are processed in a single process or a series of processes and to have uniformity. Sometimes it may be necessary to divide the plot into a number, then gathered together to form a final homogeneous batch. In the case of sterilization in the last paragraph, the batch size is determined by the capacity of the autoclave. In continuous production, batch must correspond to a defined portion in production with characteristic is the expected. Lot size can be specified as a fixed product or a product produced in a fixed period of time.
The batch number Is the obvious combination of numbers and/or letters to uniquely identify a lot, recorded on the label, in the batch record, on the corresponding test votes, etc.
Lot records all documents related to the production of a batch of semi-finished or finished products. They show the history of each batch of products, and of the situation regarding the quality of the final product.
Semi-finished products have passed through all the stages of production, except for the packaging.
Calibration of a series of operations aimed to set out certain conditions, a relationship between the values have been due to a device or a system of measurements (especially weight) records, and control, or values represented by a material measure, compared with the corresponding values were known of a standard collation. Need to establish the limited acceptance of the measurement results.
Clean area an area that perform environmental control measures identified for the primary segment and micro-organisms, built and used in a manner that can reduce the bring in, create and keep the junk in the infection-causing factors the scope of that area.
 
The shipment (or deliveries) in a pharmaceutical quality produced by a manufacturer and provided a further (at a time) in a proposal or specific orders. A shipment may include one or more containers or the antenna-the bow tie and can include the products of one or more batches.
Journal of infection is the infection of unwanted impurities have chemical or microbiological nature, or of strange droppings into a minor initial raw materials or intermediate products of the manufacturing process, sampling, packaging or repackaging, storage or shipping.
An important operation is the operation in the production process can cause variations in the quality of pharmaceutical products.
Cross-contamination of The original material, a contaminated product, or product into an original material or other products in the production process.
Finished products A complete form has undergone all stages of production, including packaging in the final packaging and labelling.
Check out the production process The check is performed in the production process in order to monitor and, if necessary, to adjust the process to ensure products meet specified standards. Controlling the environment or equipment may also be considered part of the examination of the manufacturing process.
Intermediate product processed products a part and have to continue through the stages of production become more semi-finished products.
Manufacturer a company performing activities such as the production, packaging, repackaging, labelling and labelling pharmaceutical products again.
The original recipe a document or set of documents specifying the raw materials and the volume of them, packaging materials, together with a description of the process and the need to be vigilant in order to produce a definite amount of finished products, as well as the instructions for processing, including checks in the production process.
The original batch of records a document or set of documents used as a root for batch records (batch records).
Packing all the manipulation, including bottled and labelled, to give a semi-finished to become a finished product. A sterile products bottled in sterile conditions, or a product that will be sterilized in the last paragraph is not usually considered part of the package.
Raw materials packaging materials, including print materials, used in the packaging of a pharmaceutical product, except the outside packaging for shipping. Packaging material mentioned here are called primary or secondary packaging depending on whether they have direct contact with the product or not.
 
A pharmaceutical raw materials or products intended for human or animal health, is presented in the form of finished products or as raw material for the products that form, are subject to the terms of the drug laws in the country of export and/or import.
The production of all the operations related to the manufacture of a pharmaceutical product, from receipt of materials, through processing stages, packaging and repackaging, labelling and labelling, until the completion of finished products.
Quality assurance quality assurance is a broad concept covering all the issues of common or separate influence to the quality of a product. That's the whole plan was set up with the aim to ensure the quality of medicinal products to meet the purpose of their use.
Quality control quality control is a process related to the sampling, testing and standards, also related to problems of organization, documentation and records rules to make sure production browsers have conducted the appropriate and necessary tests, and materials are not for use or product not to be selling or providing as if they haven't been rated as quality.
Special hosting original material condition or packaging materials, intermediate products, semi-finished or finished products were split to separate a mechanical way or by other effective measures, while waiting for the decision to allow the factory, eliminating or recycling.
Collation comparison between theoretical and actual amounts of weight.
The recovery brought a part or the whole production batch (or solvent has been distilled, or similar products) have reached the quality regulations, on a production batch in a stage defined in the manufacturing process. Recovery including the removal of impurities out of the waste to obtain a pure substance or restoration materials used to reuse for other purposes.
Processing back bringing the whole or part of a batch/batch processing, drug product (final biological products before packing) or semi-finished products of a single batch/lot back earlier production steps in the manufacturing process was assessed, as does not meet the quality standards specified in advance.
The process of processing back sometimes is necessary for biological products, in that case, the processing must have been appraised and approved before the license.
Bringing recycling products are intermediate products, processing (biological products before finally packing) or semi-finished products of a single/batch batch processing again by a different manufacturing process do not reach the intended standard. The recycling is so unexpected and no case was approved earlier in the product license.
Closed area

The factory base ensures complete separation on all aspects, including the relocation of staff and equipment, according to well established procedures, controls and monitoring closely. Closed areas include the mechanical barrier as well as the air handling system is separate, but not necessarily located in two separate buildings.
A standard list of specific requirements that the products or materials used or obtained during the production process to achieve. The standards are used as a basis for assessing quality.
Standard operation procedures (SOP) a process in writing and approved, take out the directions for the implementation of the operation, are not necessarily specific to each product or material (for example, operation, maintenance and cleaning air; appraisal; factory hygiene and environmental control; sampling and inspection). Some SOPS can be used to complement the product profile and the original batch production records for the specific product.
Original material A quality determined substances used in the production of a pharmaceutical product, but not the packaging material.
Evaluation of an activity to demonstrate that a process of manipulation, processing, machines, materials, activity or system that actually bring the results as desired.
II. The principles 1. Pharmaceutical quality medicinal principles put into processing, production to quality assurance in accordance with the regulations.
Medicinal origin all medicinal herbs must have detailed information about the sources, source, method of harvesting, processing and storage. This material should be preserved in the conditions are controlled, monitored and must be systematically arranged.
The purchase of the original medicinal to have contracts with vendors, including terms to ensure the quality and stability of raw materials, including reports on changes in the process of harvesting, production, processing and processing of medicinal herbs.
All medicinal herbs before entering the repository must be inspected sensory surfaces and humidity along the relevant norms. Need to have the track record and periodically check the records, inventory, import export.
Quality control of all the original material and medicinal herbs are used in the production process must have quality standards.
Need to have enough equipment, facility staff are trained and procedures are approved to perform the sampling, inspection and testing, medicinal intermediate products, semi-finished products and finished products.
Need to have 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 finished products have to be made by the methods and the employees are parts quality control approval.
Need the profile notes, to prove that all the process of sampling, checking and necessary testing was actually in progress, and any discrepancies would compare with the process are documented fully in the profile and are investigating.
To record the test results and tested according to standards for pharmaceuticals, 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 to product testing later if necessary.
The preservation of medicinal herbs should be preserved in the private sector. Conservation area should be well ventilated, and must be designed in a way likely to resist insects or other animals penetrate, especially rodents. To take measures to prevent the possibility of any animals or microorganisms that would follow the same medicinal herbs and cross-infection prevention.
Pay special attention on hygiene and maintenance of good conservation area especially when there arises the dust.
The preservation of medicinal herbs, extracts, high extraction or other other products subject to the special conditions of temperature, humidity and light; These conditions need to be maintained and monitored.
When medicinal herbs and the intermediate products are brought into the warehouse area, must be stored separately in special storage areas and warehouses of special labeling.
To have the system quality control label: different label types available for the nickname, accept and remove with the necessary information: name, number, number of batch materials test, on export/remove/test date, expiration date. Only those who are responsible for checking the quality of the new specified tagged determine initial material condition;   
Medicinal herbs are removed should be clearly labeled indicating the status and preserved separately and separate from the medicinal herbs are acceptable.
2. Personnel training principles, Must have sufficient qualified staff to perform all the work in the scope of responsibility of the manufacturer. Need to clearly define personal responsibility, this responsibility must be personally concerned understand and are recorded in a job description.
Personnel Must have sufficient qualified staff and appropriate experience for the parts. The clear separation of personnel in manufacturing, storage and testing.
Personnel must be educated about the processing, production of medicinal herbs, have sufficient qualifications and practical experience in the manufacture of drugs and medicines from medicinal herbs.
In charge of the manufacturing, quality control, storage must have knowledge, especially about the pharmaceutical expertise.
A sufficient number of personnel primarily responsible for monitoring the operation. The individual responsible for monitoring must be trained and have sufficient expertise, experience in the field is assigned. Is there a description of the functions and tasks of the key staff.
Train staff to receive training and retraining. Must have periodic training programmes, approved annually. Staff must have personnel records showing and personal training.
3. Workshop, workshop guidelines equipment must be located, designed, build, repair and maintenance in accordance with the production operation will take place.
3.1. conservation areas conservation areas are wide enough, in accordance with the scale of production, and have appropriate isolation: initial raw materials and packaging materials, intermediate products, semi-finished and finished products, special products, the product exports, eliminated, bounced or product recall.
Have the area reserved for substances that require special preservation such as solvents, flammable materials, poison, mental direction and similar substances.
The conservation area is sealed and locked in where needed.
Conservation areas must be designed or adjusted to ensure good preservation conditions. Especially to clean, dry, and light enough to maintain acceptable temperatures. There are tools to monitor humidity, temperature and must have track records.
Arsenal must take measures to prevent the entry of insects, rodent, bird ...
3.2. The manufacturing sector to ease cleaning and prevent cross-infection when the production operations have born dust, special measures are needed while sampling, weighing, mixing, blending (for example: the use of System cleaner or a private area for each type of product) processing area/medicinal processing must have separate areas for handling preliminary processing of pharmaceutical materials such as: do the essential cleaning and removing impurities, sandy soil, the parts are not used, washed, cut, dried and processed medicinal (where wash deck, medicinal or dried medicinal herbs by request).            Each area must be arranged preliminary arrangements to ease sanitary and convenient operation. Clean water system for processing medicinal herbs to ensure hygiene standards.
Pharmaceutical processing area must be separate from the manufacturing areas. Pharmaceutical processing areas as: extract, high cooking stars laced, extraction, ..., must, ensure the quality and safety of medicinal herbs.
The area of production of finished products of factories must have appropriate location, not contaminated, designed, ensuring convenient operation, maintenance and cleaning of the suit, to avoid the adverse effects of the weather.
The factory must have areas to identify and control appropriate for the stage of production. The factory is built, maintenance and protection against insects, rodents, birds, lizards, insects and other animals invade and reside.
Sewage systems and disposal of waste substances, wastes, as appropriate. To have the system running water, pure water production.
The design, the layout of the rooms to ensure the principle of direct current for the shipping of raw materials, personnel, waste products, and to prevent the products being mixed and/or cross-infection.
The loss of initial raw materials need to be made in separate scales are designed for this purpose.
The area of the factory packaging must be designed and arranged specifically to avoid confusion and cross infection.
Lighting systems are designed and installed to fully ensure the work being conducted correctly.
Workshops to ensure neat, clean, maintenance, maintenance in good condition.
3.3. quality inspection area test area must be separate from the manufacturing areas. Those areas to conduct biological, microbiological tests must be separated from each other.
Quality control rooms must be designed in accordance with the operation will proceed in that, is there an area of wide enough to avoid confusion, cross infection, and enough to preserve the template, standard substances, solvents, reagents and profile.
3.4. the auxiliary system air conditioning systems must have factory air conditioning systems iÒu ® µ cough hoÆc separate for the different areas: manufacturing, testing, maintenance, microbiological testing area, production area of sensitive substances, toxicity.
Water factory systems must have a water treatment system achieving consistent standards of service production and must have program, the plan of sampling, test the water quality.
Wastewater treatment systems must be factory wastewater treatment system.

The drainage line is large enough, be designed and equipped to avoid reflux. If possible, avoid open water discharge. But if it should be necessary to have built the farm for ease of cleaning and disinfect.
The system of fire, fire with fire, fire extinguishing system is confirmed also the validity of the relevant regulatory bodies on the status of operation of the fire extinguishing system.
3.5. Plant production equipment must be fitted with necessary equipment suitable for the production of the drugs needed for production.          
The devices must be designed, built, selection, layout and installation and maintenance of appropriate aims to minimize the risk of errors and allows for cleaning and maintenance of effective, to avoid cross-contamination, accumulation of dust and dirt, and generally avoid the adverse effects for the quality of products.
Weight and measuring equipment must be calibrated according to the calendar. The calibration, and evaluation must be conducted in full and the results should be documented.
To have the process of guiding the cleaning and maintenance of equipment, instrument and must be in full compliance.
 
3.6. The area of sanitary toilet area and the Foyer are separated from the other areas. 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 preservation.
4. Hygiene and sanitation principles need to implement the principles of factory sanitation and personal hygiene at a high level in every aspect of the production process. The scope of implementation of the principles of factory sanitation and personal hygiene includes employees, factories, machinery, equipment and tools, the production of raw materials and packaging, products used to clean and disinfect, and anything can become sources of junk for infection-causing products.
Hygiene standards have to have standards for the inspection of hygiene in the production of:-the specified hygiene methods consistent with the characteristics of the medicinal herbs are being processed and the substance or device for cleaning.
-Standard work outfit.
-How to check the health condition of the employee.
-hand washing and antiseptic way.
Sanitary methods Must have the processes and methods of factory sanitation and proper equipment. This process must be periodically reviewed and approved.
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.
The cleaning with a brush or compressed air must make a very careful, if be should avoid using a brush or compressed air for cleaning.
Personal hygiene of staff assigned to handle pharmaceutical needs to perform personal hygiene in high level, fully trained for maintaining sanitary conditions. Need to have the provisions not be involved if the producers be infected infection or skin disease.
Take measures to protect the staff avoid direct exposure to the toxic substances, medicinal herbs have the ability to cause allergies: is full of gloves, hats and protective clothing, masks, take suitable footwear during processing.
All staff should be checked before and health as being employed. These employees perform the check by the eye should be periodically checked.
Staff must be educated about personal hygiene practices. All employees involved in production must adhere to the rules of personal hygiene in high level. In particular, staff must be instructed to wash the hands before entering the production area. Need signs and rules of the control with respect to the area of production, testing, microbiological testing and warehouse area. The instructions and regulations must be taken seriously.
Anyone at any time would have been markedly illness expression or open wound can have adverse effects to the quality of the product are not permitted to join the initial raw material handling, packaging materials, raw materials in the production process, or product until condition is no longer at risk.
All staff must be instructed and encouraged to report to the person in charge directly any status whatsoever (related to the plant, machinery, equipment or staff) that they said could adversely affect the product.
Operators should avoid direct contact with the original raw materials, packaging materials, intermediate products and finished products for sale.
Staff must have protective clothing appropriate labour.
Not allowed to smoke, eat, drink, chew, to trees, food, beverage and tobacco as well as the healing of individuals in the area of production, quality inspection and preservation areas, or in other areas that can cause adverse effects to product quality.
Personal hygiene procedures, including the use of protective clothing must apply to all staff to go into the area of production, whether official or employee is temporary, or is not the employees, such as employees of the contracted party, visiting, the senior management cadre , and inspectors.
5. Principle of document profile To set the profile system documentation to determine the criteria and processes for all raw materials and production methods are defined as well as quality control; to ensure all employees are related to the production of all understand the need to do anything on time; 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.
5.1. criteria for The initial raw materials, intermediate products, semi-finished products, finished products must have adequate standards and methods of analysis. The original material must be consistent with the standards of Vietnam, Pharmacopoeia standards and regulations on the quality and hygiene of the Ministry of health.
Standards for initial raw materials and packaging materials standards for raw materials, primary packaging original packaging and printing if appropriate description is required for materials, including:-name (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, if available.
-The qualitative requirements and quantitative limits allow.
Depending on the requirements of the standard, companies can add other information, such as: provider and manufacturer of original materials, packaging printing templates, guides and sampling testing, or reference to procedures performed, the conditions of preservation and careful the maximum preservation time limit, before testing again, expires.
Packaging materials are standard and are compatible with the materials and/or products contained therein. Materials should be checked on the 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.
Standards for intermediate products and products need to have 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.
Finished product standards product standards require:-product name and reference code if available;
-Component name/active ingredient;
-Formula or formula reference;
-Description of dosage and details of packaging;
-Manual sampling and testing, or reference to procedures performed;
-Inquiries about quantitative and qualitative, with the allowable limit;
-Conditions of preservation and careful if there are;
-Expires.
Are there tests 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 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.
5.2. manufacturing formula and processing instructions all the products produced at the plant must have the original patent formula which describes in detail, the full production process. The original recipe to be updated and be accepted, review by the quality assurance Department.
To 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.
Need to 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.         
For the period of manufacture 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.     
5.3. batch records must have 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 test results, process conditions, check the equipment before the start and during the production process, Pack and store the sample label on the packaging.
Batch records are correct as of the form and the full expression of the original recipe.
Batch processing records must be reviewed and signed as appropriate.
5.4. process and profile records must have the standard operation procedure guide the 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.
6. The production and control of the production process the principle production operations must be performed according to the procedure already registered in the license production and circulation, the goal is to get the products with the quality requirements.
6.1. the initial raw materials all original materials or raw materials used in the production process must have quality standards and must be checked, tested quality.
There are several import, export, and inventory records to can be reconciled.
The handling of 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 profile. This material should be preserved in the condition control and specify limits on use or testing.
The materials and the products eliminated the need to 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.
There is a revolving inventory programs according to the principles of the previous expiration-export (FEFO) and enter before-previous (FIFO).
Packaging 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.
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.
The sampling has a regulation on labelling specify the bins, packaging material was 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.
6.2. Production batches, batch numbering system systematically 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,.
Weight and area allocated weight 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.
Prudent measures to avoid cross-contamination during the loss.
There is a system to manage the allocated initial raw materials, intermediate products and finished products for sale.
 
The production Is arranged, the number of 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, measurements must be calibrated and accurate matching of materials needed weight, swung.
To have preliminary procedures, handling of medicinal herbs. When processing medicinal herbs to pay attention so that the processing does not harm pharmaceutical.
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 from a cavity or stamping stations, close the capsule to test or use 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.
The water used in the manufacture of medicinal products drugs must meet minimum standards of pure water.
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.
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.
6.3. Labelling, packing and distribution of packaging Should have the standard packaging and packaging direct in available. Must have the SOP for the activities of receiving, sampling, packaging material testing.
 
Packaging and labeling activities the activities labeled and packaged to 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.     
Preservation and distribution Must build the SOP for the preservation of finished products shipped in shipping area. To have the records to allow quick identification of all the customers have purchased finished products of a batch/batch determines which specify the time, quantity, packing and shipping of each batch of product for the customer. Have stored the records of storage time, temperature and other preservation conditions prior to delivery.
6.4. production hygiene 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.
7. Quality control principles

Quality inspection departments need to independently of other parts and administered by a qualified and experienced person to 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.
HR 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 shipment.
The room must have sufficient quality control employees are trained appropriately, has the expertise and experience to get the job done.
Equipment quality control Rooms must be designed accordingly, ensure enough room for professional tools, equipment, records and document workspaces for employees.
Quality control rooms must be equipped with the proper tools, equipment for 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.  
Record, document the laboratory must 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.
Profile analysis must have full information about the sample, test method, results analysis and must be printed with the following minimum information: Name, origin/sample-where the production of reference code, if available.
-the batch number, expiration, requirements analysis (number, date and content)-receipt of samples, sample recipient-standards and testing methods-model status when received and before the analysis results analysis (including calculus) analysis of records must be saved to the profile tested along with the results of the analysis. Analysis of votes must be signed by the person's name and the test monitor.
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 proofreading.
-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.
Follow-up program must have stability and stability track record of smoking. The track record of stability of medicines must be kept.
8. Complaints and product recall complaints about products with the writing process to handle all complaints and specify who is responsible, forward, review and reviews complaints about the product. The handling of the complaint products must be recorded in writing and kept in a certain time.
Products returned have the writing process to receive and test pharmaceuticals bounced back and have to set the track record of the products being returned. 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, on returns, the final decision and date.
The returned products must be clearly identified and preserved in the quarantine area.
Recovery products Have written procedures 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.
9. The Inspector and the Inspector himself Must build the program yourself and determine the appropriate inspection team members. To record the self inspection and reporting inspection order to take the appropriate corrective action.