Thông tư 32/2020/TT-BYT

CIRCULAR

ON STANDARDS FOR PROCESSING AND PREPARATION OF TRADITIONAL DRUGS IN TRADITIONAL MEDICINE ESTABLISHMENTS

Pursuant to the Law on Pharmacy dated April 06, 2016;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 on functions, duties, powers and organizational structure of the Ministry of Health;  

At the request of the Director General of Traditional Medicine Administration of Vietnam;

The Minister of Health hereby promulgates a Circular on standards for processing and preparation of traditional drugs in traditional medicine establishments as follows:

Article 1. Scope

1. This Circular provides for standards for processing and preparation of traditional drugs in traditional medicine establishments which process and prepare traditional drugs and declaration of conformation to such standards.

2. This Circular is not applicable to preparation of oriental drugs and decoction drugs for treatment of patients in traditional medicine establishments. Decoction methods are provided for in Decision No. 26/2008/QD-BYT dated July 22, 2008 by the Minister of Health on technical traditional medicine procedures.

Article 2. Definitions

1. “processing of traditional drug ingredient by traditional method” means the process that results in qualitative and quantitative changes of a herbal ingredient into a traditional drug ingredient according to traditional medicine principles and methods or folk experience, including primary processing, slicing and complex processing.

2. “traditional drug preparation” means the process of combining or transforming herbal ingredients and/or traditional drug ingredients into a traditional drug in any of the following traditional or modern dosage forms:

a) Traditional dosage forms include finished products in the form of glue, hard pill, soft pill, medicinal powder, medicinal tea, medicinal alcohol or tincture.

b) Modern dosage forms include finished products in the form of compressed tablet, soluble powder, soluble granules, dripping pill, syrup, hard capsule, soft capsule, aerosol or another form.

Article 3. Traditional drug processing and preparation standards

1. Traditional medicine establishments processing herbal ingredients and/or traditional drug ingredients shall apply the standard in Appendix I enclosed therewith.

2. Traditional medicine establishments preparing traditional drugs in traditional dosage forms shall apply the standard in Appendix II enclosed therewith.

3. Traditional medicine establishments preparing traditional drugs in modern dosage forms shall apply the standard in Appendix III enclosed therewith.

4. For provincial traditional medicine hospitals processing and/or preparing and selling traditional drugs to other healthcare establishments practicing traditional medicine located in their respective provinces, these hospitals shall comply with regulations in Appendix VI and Appendix VII of Circular No. 35/2018/TT-BYT dated November 22, 2018 by the Minister of Health on Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials and be assessed according to regulations of this Circular.

Article 4. Applications for declaration of conformity to traditional drug processing and/or preparation standard(s)

An application for declaration of conformity to traditional drug processing and/or preparation standard(s) (hereinafter referred to as “declaration application”) includes:

1. Copy of operating license of the traditional medicine establishment;

2. Declaration of eligibility for traditional drug processing and/or preparation made using Form No. 01 in Appendix IV enclosed therewith;

3. Report on traditional drug preparation and/or processing made using Form No. 02 in Appendix IV enclosed therewith.

Article 5. Procedure for declaration of conformity to traditional drug processing and/or preparation standard(s)

1. The applicant shall submit a declaration application via the online public service system or by post or in person to the receiving authority (Ministry of Health or Department of Health) according to the following regulations:

a) Traditional medicine establishments under management of the Ministry of Health and health units of ministries and central authorities shall submit an application to the Ministry of Health (Traditional Medicine Administration of Vietnam).

b) Traditional medicine establishments under management of Departments of Health shall submit an application to Departments of Health.

2. Within 30 days starting from the date written on the acknowledgement of receipt of declaration application, which is made using Form No. 3 in Appendix 3 enclosed therewith, the receiving authority mentioned in Clause 1 herein shall consider the application and perform the following tasks:

a) If the application meets requirements, the receiving authority shall make an announcement on its website using Form No. 06 in Appendix IV enclosed therewith.

b) If the application fails to meet requirements, the receiving authority must send a written explanation and request for application amendment to the applicant.

Within 60 days starting from the date written on the request for application amendment, the applicant must send an amended application to the receiving authority.

Within 07 working days starting from the date of receipt of the amended application, the receiving authority shall assess the application and make an announcement on its website if the application meets requirements. Otherwise, it shall send a written explanation and request for application amendment to the applicant. If the applicant fails to amend its application within 60 days starting from the date written on the request for application amendment, its application will be invalidated.

3. In case of change of the person in charge of the processing/preparation operations, area or equipment of a traditional medicine establishment, the establishment shall notify the change to the receiving authority mentioned in Clause 1 herein in writing. The establishment may process and/or prepare traditional drugs immediately after sending the notification. The receiving authority shall carry out post-inspection of this change.

Article 6. Inspection and assessment of conformity to traditional drug processing and/or preparation standard(s)

1. In November of every year, authorities receiving declaration applications shall announce their plans for inspection and assessment of maintenance of conformity to traditional drug processing and preparation standards (hereinafter referred to as “conformity inspection”) on their websites and send these plans to the establishments mentioned therein.

2. At least 30 days before the date of conformity inspection according to the plans announced by the receiving authorities, the inspected establishments must send a report on traditional drug processing and/or preparation activities to the receiving authorities, which is made using Form No. 2 in Appendix IV enclosed therewith.

E.g., Establishment A is expected to undergo the inspection on October 28, 2021, thus, establishment A must submit a report on its traditional drug processing and/or preparation activities to the receiving authority before September 28, 2021.

3. Establishments failing to submit a report on their traditional drug processing and/or preparation activities within the time limit mentioned in Clause 2 herein shall be subject to an ad hoc inspection of their traditional drug processing and/or preparation activities by receiving authorities.

4. Conformity inspection shall be recorded in writing using Form No. 4 in Appendix IV enclosed therewith.

5. Handling of conformity inspection results:

a) If the conformity inspection results of an establishment are rated Level 1 according to regulations in Appendix V of this Circular, the establishment may continue to process and/or prepare traditional drugs;

a) If the conformity inspection results of an establishment are rated Level 2 and the establishment has any serious issue according to regulations in Appendix V of this Circular, the receiving authority shall request the establishment to address the issue in writing.

- Within 45 days starting from the date upon which the receiving authority requests the establishment to address the serious issue in writing, the establishment must finish settling the issue and send a report together with proof (documents, images, videos, certificates and other documents) of such settlement;

- Within 10 days starting from the date of receipt of the report and proof (documents, images, videos, certificates and other documents) from the establishment, the receiving authority shall assess how the issue was settled and draw a conclusion about conformity to processing and/or preparation standard(s) of the establishment;

+ If the settlement is satisfactory, the receiving authority shall issue a written approval of the settlement;

+ If the settlement is unsatisfactory, the receiving authority shall revoke the declaration published on its website and handle according to regulations in the Government’s Decree No. 117/2020/ND-CP dated September 28, 2020 prescribing penalties for administrative violations in medical sector.

c) If the conformity inspection results of an establishment are rated Level 3 and the establishment has any critical issue according to regulations in Appendix V of this Circular, the receiving authority shall revoke the declaration published on its website and handle according to regulations in the Government’s Decree No. 117/2020/ND-CP dated September 28, 2020 prescribing penalties for administrative violations in medical sector.

Article 7. Implementation

1. Traditional Medicine Administration of Vietnam shall:

a) Provide guidelines for, organize, inspect and assess implementation of this Circular throughout the country.

b) Inspect and assess traditional medicine establishments at central level and of ministries and central authorities.

c) Direct Departments of Health to implement this Circular.

d) Announce and update list of establishments eligible for on-site traditional drug processing and/or preparation according to regulations of this Circular on its website in a regular, adequate and accurate manner.

2. Departments of Health and health authorities of ministries and central authorities shall:

a) Direct and organize implementation of this Circular in localities and units under their management;

b) Inspect and assess results of implementation of this Circular in localities and units under their management;

c) Announce and update lists of traditional medicine establishments eligible for traditional drug processing and/or preparation using Form No 5 in Appendix IV enclosed therewith on websites of Departments of Health in a regular, adequate and accurate manner.

d) Submit reports using Form No. 6 in Appendix IV enclosed therewith to the Ministry of Health (Traditional Medicine Administration of Vietnam) before December 31 of every year to update information on traditional medicine establishments eligible for traditional drug processing and/or preparation to the information system of the Ministry of Health (Traditional Medicine Administration of Vietnam).

3. Traditional medicine establishments shall:

a) Comply with the regulations on this Circular;

b) Self-assess conformity to processing and/or preparation standard(s) of the drugs that they process and/or prepared according to regulations of this Circular and take responsibility for declared information.

c) Submit reports using Form No. 02 in Appendix IV enclosed therewith to the receiving authorities mentioned in Clause 1 Article 5 of this Circular upon receipt of conformity inspection plans before December 31 of every year.

Article 8. Transitional clauses

For drugs prepared by traditional medicine establishments and covered by the health insurance fund according to regulations in Circular No. 05/2015/TT-BYT dated March 17, 2015 by the Minister of Health on promulgation of list of oriental medicines, herbal medicines and traditional ingredients covered by health insurance and Circular No. 50/2017/TT-BYT dated December 29, 2017  by the Minister of Health amending and supplementing regulations on reimbursement of costs of covered medical services, if the traditional drug ingredients of these drugs are processed before December 31, 2022 and these drugs are prepared before December 31, 2023, the health insurance fund shall continue to reimburse the costs of these drugs for the establishments until these drugs expire.

Article 9. Terms of reference

In case the documents cited in this Circular are amended or superseded, the newest documents shall apply.

Article 10. Roadmap to implementation

1. Traditional medicine establishments processing traditional drug ingredients must declare their conformity to standard for traditional drug ingredient processing according to regulations of this Circular before December 31, 2022.

2. Traditional medicine establishments preparing traditional drugs must declare their conformity to standard for traditional drug preparation according to regulations of this Circular before December 31, 2023.

3. Traditional medicine establishments are encouraged to implement this Circular before the deadlines mentioned in Clauses 1 and 2 of this Article.

Article 11. Effect

This Circular takes effect from February 17, 2021.

Any difficulty arising during the implementation of this Circular should be promptly reported to the Ministry of Health (Traditional Medicine Administration of Vietnam) for consideration and guidance./.

APPENDIX I

STANDARD FOR PROCESSING OF HERBAL INGREDIENTS AND TRADITIONAL DRUG INGREDIENTS
(Enclosed with Circular No. 32/2020/TT-BYT dated December 31, 2020 by Minister of Health)

I. General provisions

1. All activities concerning processing and preparation of traditional drugs (hereinafter referred to as “processing and preparation") shall have systemized personnel, facilities, equipment and documents to ensure that traditional drugs are processed and prepared in a stable manner and in compliance with quality requirements of quality standards.

2. Processing and preparation area must be arranged in a one-way manner and in compliance with technical, safety and hygiene requirements and other necessary conditions to meet technical processing and preparation requirements.

II. Personnel

1. The person in charge of professional operations and quality of a traditional drug ingredient processing establishment must hold at least one of the following degrees, diplomas and certificate:

a) Bachelor’s degree in pharmacy;

b) Bachelor’s degree in traditional medicine or bachelor’s degree in traditional pharmacy;

c) College degree in pharmacy;

d) Intermediate professional education diploma in pharmacy;

dd) Intermediate professional education diploma in traditional medicine or traditional pharmacy;

e) Traditional medicine practitioner certificate.

2. The person in charge of professional operations of the establishment must be in good health and have appropriate qualifications and experience in processing herbal ingredients and/or traditional drug ingredients. Persons directly involved in primary processing, complex processing and processing of traditional drug ingredients must regularly participate in training and refresher courses in primary processing, complex processing and processing of traditional drug ingredients.

III. Primary processing and processing area

1. Location, design, construction, repair and maintenance of the area for primary processing and processing of herbal ingredients and/or traditional drug ingredients of the establishment must be suitable for primary processing and processing steps and size. This area must be separated from other areas and have a sufficient lighting system to ensure operational accuracy.

2. There shall be separate areas for primary processing and processing of herbal ingredients and/or traditional drug ingredients. Primary processing and processing area must be sufficiently large, well ventilated and easy to clean, ensure manufacturing safety and ease of operation, and have a water supply system for primary processing and processing.

3. Premises of the processing area must be arranged in a manner that ensures processing steps are taken in a consecutive and reasonable order appropriate to processing and preparation procedures and necessary sanitary level. Herbal ingredient primary processing and preparation area comprises areas for the following steps: impurity removal; soaking, fermentation; washing; cutting; drying, seasoning, fermentation; cooking and other steps. Herbal ingredient washing area and herbal ingredient drying area or yard shall be arranged as needed and suitable for the establishment’s size. The primary processing and processing area shall have area of at least 18m2 and volume of at least 54 m3.

4. There is a water supply system meeting at least domestic water standard for herbal ingredient processing in compliance with hygiene requirements. Water used to wash an herbal ingredient must not be used to wash another herbal ingredient.

5. Labeling and packaging area: there is a separate area for labeling and packaging, which must have physical dividers to prevent mixing products with packaging. Samples of printed labels and packaging must be archived in dossiers. All herbal ingredients and traditional drug ingredients must be identified and labeled according to regulations on medicine and medicinal ingredient labeling of the Ministry of Health.

6. Storage: the storage must comply with regulations on storage of the Ministry of Health.

III. Equipment

1. The establishment must provide sufficient equipment suitable for the processing method and procedure of each herbal ingredient and traditional drug ingredient. Such equipment must meet technical specification requirements and primary processing and processing needs of the establishment, including equipment for washing, cutting, soaking, fermentation, drying and cooking and other equipment, to prevent cross-contamination, dust and contamination accumulation and negative impacts on product quality.

2. Scales and primary processing and processing equipment must be calibrated, cleaned and maintained on a periodic basis.

IV. Hygiene regulations

1. Primary processing and processing area must be cleaned on a regular basis.

2. Guidelines for cleaning and maintenance of primary processing and processing equipment must be available.

V. Documents

1. The establishment must retain documents on equipment, herbal ingredient origin, traditional drug ingredient and herbal ingredient quality and batch documents.

2. The establishment must comply with application regulations on quality control for herbal ingredients and traditional drug ingredients of the Ministry of Health.

3. The dossier on each processing/preparation batch shall include name of the herbal ingredient/ traditional drug ingredient, product weight; processing date; and batch number. All dossiers must specify the time, have signature of the person in charge of professional operations and be retained at the manufacturing location until the product expiry date.

VI. Control during primary processing and processing

Pharmaceutical starting materials and packaging materials are subject to quality control. The establishment shall prepare records of import, export and inventory of ingredients, herbal ingredients, traditional drug ingredients and additives used in processing of traditional drug ingredients.

APPENDIX III

STANDARDS FOR PREPARATION OF TRADITIONAL DRUGS IN MODERN DOSAGE FORMS
(Enclosed with Circular No. 32/2020/TT-BYT dated December 31, 2020 by Minister of Health)

Chapter I

GENERAL PROVISIONS

1. All activities concerning processing and preparation of traditional drugs (hereinafter referred to as “processing and preparation") shall have systemized personnel, facilities, equipment and documents to ensure that traditional drugs are processed and prepared in a stable manner and in compliance with quality requirements of quality standards.

2. Processing and preparation areas must be arranged in a one-way manner and in compliance with technical, safety and hygiene requirements and other necessary conditions to meet technical processing and preparation requirements.

Chapter II

PERSONNEL AND TRAINING

2.1. General provisions

2.1.1. Persons in charge of professional operations and preparation, inspection and control of quality and storage must have professional knowledge about traditional drugs. At least one of those in charge of preparation, inspection and control of quality must hold a bachelor’s degree in pharmacy.

2.1.2. All responsible officials must have a detailed job description and be delegated suitable powers to perform their duties. Their duties may be delegated to their qualified deputies. An organizational chart must be available.

2.2. Key personnel

2.2.1. Key personnel include heads of preparation units, heads of quality units and authorized persons. Heads of preparation units and heads of quality units must be independent of each other. In some cases, these units may be combined into one unit. Authorized persons may take responsibility for one or more than one of these quality units.

2.2.2. A person with suitable qualifications and experience may be designated to approve release of a batch of finished products or a product following an approved product release procedure. This task is usually carried out by quality assurance units via batch dossier review.

Chapter III

FACTORIES AND EQUIPMENT

3.1. General provisions

3.1.1. Location, design, construction, repair and maintenance of factories of the establishment must be suitable for preparation steps and size. Preparation areas, administrative areas and operational areas must be arranged in a suitable manner and separated from each other.

3.1.2. Factories must be located away from pollution sources such as polluted water, land or air or other nearby activities; and protected against the weather, flooding, floor cracks, insects, rodents, birds and other animals. Factories and surroundings thereof must be kept clean and tidy.

3.1.3. Factories must be clean, dry and sufficiently lighted, warm and humid (if necessary). Fire safety equipment and environmental monitoring equipment must be available. Monitoring must be recorded in writing.

3.2. Storage areas

3.2.1. Storage areas must be sufficiently large and suitable for preparation size, and have separated warehouses for fresh herbal ingredient (if any); herbal ingredients having undergone primary processing, packaging materials, semi-finished products, finished products, and rejected products, returned products or recalled products.

3.2.2. Design of storage areas must ensure protection against insects, rodents and other animals, and include measures against the spread of animals and microorganisms in herbal ingredients to prevent fermentation, mold and fungi development and cross-contamination.

3.2.3. Storage areas shall be kept at temperature and humidity level suitable for stored items or according to manufacturers’ instructions. Shelves must be arranged in a manner that ensures ventilation.

3.2.4. Herbal ingredients, ingredients and packaging materials accepted or requiring special storage, semi-finished products and finished products, products requiring special storage, products permitted to be released, and rejected products, returned products or recalled products must be distinguishable and suitably isolated in storage areas. Herbal ingredient storage areas and finished product storage areas must be arranged in compliance with regulations and standards of corresponding good storage practices.

3.2.5. Toxic herbal ingredients or rare/ precious herbal ingredients must be stored in dedicated packaging or separate rooms/ areas and affixed with dedicated labels. Extracted fluids, extracted glues and other preparations must be stored in proper humidity, temperature and light conditions, which must be maintained and monitored throughout the storage process.

3.2.6. Substances requiring special storage such as solvents, flammable and explosive ingredients, toxic substances and similar substances shall be storage in dedicated areas.

3.3. Herbal ingredient primary processing and processing area

3.3.1. Preparation rooms of the herbal ingredient primary processing and processing area must be arranged according to the one-way movements of personnel, ingredients, products and waste to prevent mixing and/or cross-contamination.

3.3.2. There shall be separate areas for primary processing and processing of herbal ingredients. The herbal ingredient primary processing area comprises areas for the following steps: impurity removal; soaking, fermentation; washing; cutting; drying and other steps. These areas must be suitably divided to prevent dust. Herbal ingredient washing area and herbal ingredient drying area or yard shall be arranged as needed and suitable for the establishment’s size.

3.3.3. Herbal ingredient drying areas must be well ventilated, protected against insects, birds, rodents and pets, and provided with sufficient shelves and other drying equipment.

Herbal ingredients must not be laid flat to dry on uncovered ground. Herbal ingredients shall be placed on plastic fabric or other suitable cover sheets if laid flat on cement or concrete floor to dry.

3.3.4. The herbal ingredient primary processing and processing area must be easy to clean, well ventilated, easily operated and equipped with a water supply system meeting at least domestic water standard for herbal ingredient processing. Water used for the final washing and rinsing step must be at least potable water. Factories must be protected against insects, specifically for the following steps:

a) For raw herbal ingredient processing (removal of impurity, dirt, sand, unneeded parts, and washing): factories must be clean, easy to clean and protected against microorganism accumulation and development. Closed water drainage pipes shall be used and measures to prevent sewage backup must be taken.

b) For cleaning, cutting, drying and primary processing of herbal ingredients (steaming, roasting, heating, seasoning, etc.): factories must be easy to clean and provided with ventilation, dehumidification and cooling equipment. Dust resulting from dust-producing steps such as cutting, grounding of raw herbal ingredients, etc. must be handled properly.

c) Powdered herbal ingredient preparation: dispensing, grinding, mixing and sifting of powdered herbal ingredients and cleaned raw ingredients directly used for traditional drug preparation must be carried out in enclosed factories equipped with air filtering and exhaust/ dust processing systems.

d) For high processing and extraction:

Factories must have smooth floor, ceiling and walls that are easy to clean and protected against microorganisms and dust; be provided with filtered air to prevent dust from the outside; and take measures to collect and process humidity generated during the preparation process in compliance with requirements.

3.4. Finished product preparation area

3.4.1. Preparation rooms of a factory must be designed and arranged as appropriate to the preparation line (dosage form, expected capacity) and one-way movements of personnel, ingredients, products and waste to prevent mixing and/or cross-contamination. Preparation areas shall be arranged based on the preparation procedure. Preparation areas must be suitable for the preparation size and producing steps carried out in one area shall not obstruct each other or adjacent preparation areas. Preparation of traditional drugs containing toxic herbal ingredients must be strictly controlled and supervised from starting ingredients to release.

3.4.2. Factories must have sufficient, neat and clean lighting systems to ensure operational accuracy. They shall be kept in good condition, be cleaned and disinfected following written detailed procedures, and retain documents on the cleaning process for each batch of finished products.

3.4.3. Factories shall be kept neat, clean and in good condition, be cleaned and disinfected following written detailed procedures, and retain documents on the cleaning process for each product batch.

3.4.4. Pipes, light bases and other services in preparation areas must be installed in a manner that avoids creating hard to clean spots and facilitates maintenance and should be located away from mixing areas.

3.4.5. Dust-producing preparation steps and activities such as sampling, weighing and mixing and activities involving raw natural ingredients must be closely supervised and protected against cross-contamination by using dust removing system, etc.

3.4.6. Rooms in preparation areas must have sufficient space for operations of personnel and storage during the preparation process as well as equipment and raw materials located in an orderly and suitable manner so as to minimize confusion between different products or product ingredients, prevent cross-contamination and minimize missing or carrying out any step or inspection improperly.

3.4.7. In areas where starting ingredients, primary packaging materials and semi-finished products coming into contact with the environment, the inside surface (walls, floor and ceiling) must be smooth, have no cracks or open connection spots and not retain or produce dust. The floor and walls of mixing areas must be made from waterproof and washable materials. The location where a wall meets the floor in preparation areas must be easy to clean. Avoid creating hard to clean and disinfect spots.

3.4.8. Other relevant activities may be carried out in separate buildings or in the same building with suitable division and in compliance with the following requirements:

a) Changing rooms must be directly connected to but separated from preparation areas;

e) Do not place toilets and break rooms in preparation areas;

f) Quality inspection rooms must be separated from preparation areas. Intra-operation control may be performed in preparation areas without affecting or jeopardizing the preparation process;

g) Maintenance unit should be located far away from preparation areas. Maintenance equipment placed inside preparation areas must be kept in a dedicated locked cabinet or room.

3.4.9. Factories must be equipped with an air control system according to the requirements of each product type and preparation procedure. To be specific:

a) Areas for raw drug selection, cutting and grinding must be equipped with vacuum cleaners.

b) Areas for raw drug steaming, roasting and heating must be provided with ventilation, dehumidification and cooling equipment.

c) Factories where drugs or cooked drugs are extracted and concentrated must be provided with equipment for prevention of contamination, microorganism and cross-contamination.

d) Factories for dispensing, grinding, mixing and sifting of cleaned raw drugs and dried glues directly used for drug preparation must be enclosed.

3.5. Weighing and dispensing areas

3.5.1. Herbal ingredients may be weighed in a separate room or separate area in the warehouse containing the ingredients.

3.5.2. Other starting ingredients must be weighed in a separate weighing area designed for weighing purpose and of appropriate class of cleanliness. The weighing area may be located in a storage area but should be located in a preparation area. After being weighed and divided into batches, the ingredients must be preserved using proper shelves, containers and management measures.

3.5.3. Before weighing and dispensing, inspect hygiene, temperature and humidity conditions of the environment to ensure that the weighing and dispensing area has been properly cleaned and the weighing and dispensing processes will be carried out with accuracy. In-charge personnel must wear appropriate attire.

Take measures to prevent cross-contamination and confusion during weighing. Formulate procedures for inspection and management of dispensing of herbal ingredients, starting ingredients and semi-finished products.

3.6. Quality inspection and control areas

3.6.1. Drug quality inspection and control areas must be separated from preparation areas. Quality inspection rooms must be designed appropriately to prevent confusion and cross-contamination and have sufficient space for preservation of samples, reference materials, solvents, reagents and control and testing documents.

3.6.2. Areas for biological testing and microorganism testing (if any) must be located separately and use different sets of air processing equipment and other types of equipment.

Chapter IV

EQUIPMENT AND AUXILIARY SYSTEMS

4.1. Equipment

4.1.1. Preparation factories must be fully provided with equipment necessary for preparation of drug products permitted to be prepared at the establishment.

4.1.2. Design, selection, manufacturing, location, installation and maintenance of preparation equipment must ensure the convenience and safety of operations, ease of cleaning and maintenance; and prevent cross-contamination, dust and dirt accumulation and adverse effects on product quality.

4.1.3. Scales and measuring equipment used in preparation and quality inspection must have appropriate scale range and accuracy, be calibrated according to regulations, be subject to periodic inspection and recording, and be properly maintained. Calibration, inspection and maintenance must be performed in an adequate manner and the results thereof must be recorded and retained.

4.1.4. Equipment cleaning and maintenance procedures must be provided and followed fully.

4.1.5. Broke or disused machinery and equipment must be moved out of preparation areas and undergo quality inspection. If a piece of machinery or equipment cannot be moved outside, it must be marked or labeled as broken to prevent being used by mistake.

4.2. Auxiliary systems

4.2.1. Heating, ventilation and air conditioning system

- Heating, ventilation and air conditioning system must meet the requirements of each operation (preparation, quality inspection, storage) and each step and each product type.

- Heating, ventilation and air conditioning system must have sufficient capacity, maintain suitable temperature and humidity, be maintained and monitored on a regular basis and recorded in writing.

4.2.2. Water processing system

Depending on the requirements of each dosage form, water used for preparation must meet at least domestic water standard or water standards in compliance with the requirements of each dosage form.

4.2.3. Wastewater, exhaust and waste processing systems

a) The establishment must take suitable measures for processing of wastewater, exhaust, waste and scraps from the preparation process to ensure safety, hygiene and compliance with regulations on environmental hygiene;

b) The establishment is encouraged to invest in waste and scrap processing systems suitable for its preparation size to ensure safety and hygiene.

4.2.4. Fire prevention and fighting systems

The establishment must have sufficient unexpired fire prevention and fighting equipment.

Chapter V

RAW MATERIALS AND HERBAL INGREDIENTS

5.1. Starting ingredients

5.1.1. Starting ingredients must be provided by assessed and approved suppliers (suppliers include both distributors and manufacturers). Ingredients must be purchased by experienced personnel.

5.1.2. All starting ingredients, including raw ingredients used in preparation, must have quality standards and are subject to quality inspection.

5.1.3. Dispatch, receipt and inventory of ingredients and semi-finished products must be recorded in writing; and inventory shall be managed using the “First Expired, First Out” (FEFO)  and “First-In, First-Out” (FIFO) methods.

5.1.4. Rejected ingredients must be clearly labeled and separately stored in a restricted area. Rejected ingredients must be stored safely and separately from accepted ingredients.

5.2. Herbal ingredients

5.2.1. Herbal ingredients must be of good quality and have clear origin.

5.2.2. For animal ingredients, the establishment shall formulate and retain documents on the source, origin, processing method, expiry date or retesting date for each batch. These ingredients must be preserved in controlled conditions.

5.2.3. Herbal ingredients must undergo quality inspection, meet quality standards and conform to relevant regulations of law before they may be used for preparation, mixing and sale.

5.2.4. Quality standards of herbal ingredients must be in compliance with existing pharmacopoeias (of Vietnam, Japan, China, etc.) and/or official technical documents (scientific research results at State or Ministry level having undergone commissioning).

5.2.5. Inspection of quality of herbal ingredients and ingredients:

a) All herbal ingredients must be subject to strict quality control from receipt. Persons with suitable qualifications and experience in herbal ingredients and traditional drugs shall perform this task for each herbal ingredient packaged unit and at different packaging locations.

b) Results of standard-based inspection and testing of herbal ingredients, ingredients, semi-finished products and finished products. Sufficient samples of herbal ingredients, ingredients and finished products of each preparation batch must be retained.

5.2.6. Primary processing:

a) Procedures for primary processing and processing of herbal ingredients must be available. Ensure that the processing process does not affect the quality of these ingredients.

b) Use primary processing and drying methods suitable for each type of herbal ingredient. Control temperature and humidity to prevent spoiling or changing bioactive components.

5.2.7. Herbal ingredient preservation

a) Monitor and record storage conditions in writing adequately; provide special notices for storage areas of herbal ingredients, extracted fluids, tinctures and dosage forms requiring special temperature and/or humidity conditions and/or shielding from light.

b) Herbal ingredients having undergone primary processing must be stored in sealed packaging affixed with basic information such as name of the processing establishment, name of the ingredient, user, marketing authorization number (if any); source/origin; package weight; primary processing, processing and packaging dates; storage conditions; batch number; expiry date; and quality and humidity standards (if any).

5.3. Packaging materials

5.3.1. Provide standards for primary packaging and pre-printed packaging. Provide SOPs for receipt, sampling and testing of packaging materials.

5.3.2. Primary packaging and pre-printed packaging shall be purchased, managed and inspected in a manner similar to that of starting ingredients.

5.3.3. Packaging materials must be stored in safe conditions to prevent illegal access and dispensed under strict supervision.

5.3.4. Other printed cut-apart labels must be stored and transported in separate well-closed containers to prevent confusion. Only authorized personnel may dispense packaging materials according to an approved written procedure.

5.3.5. Each delivery or batch of primary packaging or pre-printed packaging must be managed by batch or individual identifying mark to enable tracing of product batch information.

5.3.6. All packaging materials and products delivered to the packaging unit must be inspected in terms quantity, identity and compliance with packaging guidelines.

5.3.7. Expired or unusable primary packaging or pre-printed packaging must be disposed of, which shall be recorded in writing.

5.3.8. Class of cleanliness of the environment of the area for the last primary packaging processing step must be the class of cleanliness of the environment of the drug processing area.

Chapter VI

HYGIENE AND HYGIENE CONDITIONS

6.1. General provisions

The establishment must follow rules for factory hygiene and personal hygiene throughout the drug preparation process, including factory cleaning, personal hygiene and cleaning of machinery, equipment and packaging materials.

6.2. Personal hygiene

The establishment must ensure that all personnel comply with personal hygiene regulations appropriate to preparation requirements and characteristics of dosage forms.

6.3. Factory cleaning

6.3.1. The establishment must formulate procedures and methods for factory and equipment cleaning suitable for the requirements of each dosage form.

6.3.2. Conditions related to factories, equipment and personnel that might adversely affect products must be reported to the direct supervisor.

6.4. Equipment cleaning

6.4.1. Provide SOPs for preparation and cleaning and maintenance of preparation equipment, which must specify cleaning duty assignment; cleaning and maintenance schedules; cleaning and maintenance methods; in-use equipment and raw materials; guidelines for protecting cleaned equipment from contamination; and control of equipment hygiene conditions prior to use. These procedures must be fully adhered to.

6.4.2. Both the inside and outside of equipment must be cleaned after use following approved procedures. Clean equipment must be kept clean and have its cleanliness inspected before use. Cleaning and post-cleaning and pre-use inspection must be recorded in writing.

6.4.3. Records of cleaning and pre-use inspection must be retained.

Chapter VII

PREPARATION AND CONTROL DURING PREPARATION

7.1. General provisions

7.1.1. The establishment must ensure that all preparation operations are performed in accordance with procedures approved by competent units.

7.1.2. Assign sufficient personnel for preparation and take suitable measures to supervise all preparation operations. All personnel must wear appropriate attire when carrying out preparation operations. Competent persons shall carry out and supervise preparation operations. Only authorized personnel may enter preparation areas.

7.1.3. Operations on different products shall not be carried out at the same time or consecutively in the same room unless there is no risk of confusion or cross-contamination.

7.1.4. Starting ingredients and finished products must be placed in special storage immediately after receipt or preparation until they are permitted to be used and distributed. Starting ingredients and finished products must be preserved in suitable conditions and arranged in an orderly manner to enable batch division and warehouse switching. Starting ingredients must be inspected to ensure that the correct ingredients have been sent/received.

7.1.5. Processing of raw materials and products, including receipt and special storage, sampling, storage, labeling, dispensing, processing, packaging and distribution, must be carried out following written procedures or guidelines and recorded in writing. Semi-finished products purchased shall be regarded as starting ingredients upon receipt.

7.1.6. Preparation must take place in accordance with procedures or guidelines. If there is any difference, such difference must follow an approved procedure. Differences must be approved by competent persons in writing. Inspect yield and compare quantities to ensure a difference does not exceed the permissible limit.

7.1.7. Take special precautions to prevent dust production and dispersal when working with dry products and ingredients. At each processing stage, products and ingredients must be protected against microorganisms and other contaminants.

7.2. Semi-finished products

7.2.1. Have special storage and dispatch systems for semi-finished products, including identification of product status (in special storage, released or rejected). Develop systems and procedures for processing of semi-finished products/unqualified finished products.

7.2.2. Final yield of each preparation batch must be recorded and compared with theoretical productivity. In case of significant change, investigate the cause before releasing or continuing with the processing process.

7.2.3. Semi-finished products awaiting packaging must be placed in special storage to undergo quality inspection before the next steps.

7.3. Preparation procedures

7.3.1. Batch numbering system

a) Have a batch numbering system described in detail, including identification of starting ingredients, packaging materials, semi-finished products and finished products;

b) Batch number assignment must be recorded immediately and include information such as number assignment date, product identification and batch size.

7.3.2. Preparation

a) Assign sufficient personnel for preparation and take suitable measures to supervise all preparation operations. All personnel must wear appropriate attire when carrying out preparation operations.

b) Procedures for primary processing and processing of herbal ingredients must be available. Ensure that the processing process does not affect the quality of these ingredients.

7.3.3. Control during preparation

a) Inspect the preparation process and environmental control, and record all results of such inspection according to preparation procedures and batch dossiers.

b) Preparation conditions and environment must meet regulatory requirements. All processing equipment is subject to pre-use inspection.

c) Take measures to contain dust for preparation steps that might produce dust such as weighing and packaging.

d) Regularly inspect and control parameters of semi-finished products at key preparation steps such as granules humidity, pill weight, pack tightness, solution pH, etc. Inspection and control shall be recorded in writing. Semi-finished products used for intra-operation inspection and control must be disposed of properly.

dd) Preparation guidelines must comprise preparation steps for raw ingredients such as drying, grinding, screening and removal of foreign materials, including drying time, drying temperature and methods used to control crumbling or grain size.

e) Perform inspection to ensure that pipes and equipment used to move products from one area to another are connected properly.

7.4. Labeling, packaging and distribution

Take measures to ensure that packaging is done in a fast manner and minimize the risk of cross-contamination or confusion or change concerning labeling and packaging. Physical dividers must be installed to prevent confusion between different products and types of packaging when packaging different products in the same packaging area. Product name and batch number must be displayed in the area where the products are being packaged.

7.5. Finished products

7.5.1. Finished products must be isolated until release in conditions established by producers.

7.5.2. Finished products and dossiers thereon are subject to inspection and assessment before the products are released.

7.5.3. After release, finished products must be stored according to storage conditions written on their labels.

7.6. Preservation and distribution

7.6.1. Formulate procedures for preservation of finished products released. Have documents that allow quick identification of all customers who have bought finished products of a certain batch, which must specify the release time, quantity, packaging specifications and delivery of each product batch to customers.

7.6.2. Retain records of storage time, temperature and other storage conditions before distribution.

7.7. Rejected, recycled and returned products

7.7.1. Rejected products must have dedicated labels and be stored separately. They must be returned to their suppliers or, if appropriate, should be recycled or disposed of. Returning raw materials to their suppliers or recycling or disposal of raw materials must be approved by competent persons and recorded in writing.

7.7.2. Recycle only a limited quantity and only when the quality of the finished product is unaffected and the recycled product still meets the applicable quality standard. Recycle according to a specified procedure after assessment of relevant risks, which must be recorded in writing.

Chapter VIII

QUALITY INSPECTION

8.1. General provisions

8.1.1. Quality inspection unit shall perform quality control and inspection tasks, including activities concerning sampling, sample storage; standard formulation; inspection and testing of quality of herbal ingredients, preparation ingredients, semi-finished products and finished products; inspection of equipment, reagents and reference substances; formulation of release procedures and documents to ensure performance of necessary tests; stamping for unqualified products and qualified products prior to release.

8.1.2. Quality inspection unit shall assess and control quality of traditional drug ingredients while they are freely circulated on the market and cooperate with relevant units in assessing capacity for quality control of ingredient and packaging material suppliers.

8.1.3. Unit in charge of inspecting and testing traditional drugs must be provided with equipment suitable for the preparation size at the establishment, independent from other units and under management of a person having appropriate qualifications and experience.

8.1.4. Quality inspection unit must have sufficient equipment and approved procedures for sampling, inspection and testing of starting ingredients, packaging materials, semi-finished products and finished products.

8.1.5. The establishment shall test each traditional drug batch and only allow it to be released when it meets the approved quality standard. Finished product assessment must encompass all relevant factors, including preparation conditions, intra-operation inspection results, preparation documents (including packaging documents), compliance with standards and inspection of the final finished products.

Quality inspection unit may perform other tasks such as formulating, appraising and following procedures for quality inspection, storing reference materials, ensuring accurate labeling of packaging of ingredients and traditional drugs, ensuring monitoring of traditional drug stability, investigating into complaints related to traditional drug quality and supervising the environment. All of these tasks must be performed as assigned in writing.

8.5. Documents

8.5.1. Quality inspection unit must have inspector handbooks, analysis documents, test sheets and analysis sheets.

Inspector handbooks shall be used to record results, calculations, figures and comments related to the analysis of a sample. These handbooks must have their pages numbered, not be written using pencils and not have their contents erased or overwritten.

8.5.2. Analysis and testing documents must contain full information on samples, testing methods and analysis and testing results, and shall be pre-printed with the following basic information: sample name, origin/place of preparation, reference code (if any); batch number, expiry date, analysis requirements (number, date and content); date of sample receipt, sample recipient; testing standards and method; state of sample before receipt and before analysis; analysis and testing results (including calculations). Analysis documents must be added to testing documents together with analysis results. Analysis sheets and test sheets must bear the signatures of inspectors and supervisors.

8.5.3. Update and retain all quality standards necessary for testing operations, including Vietnamese pharmacopoeia and foreign pharmacopoeias as well as appendixes, amendments and revisions thereof, and quality standards not included in pharmacopoeias for drugs tested based on standards of their manufacturers. Laboratories shall research and promulgate testing methods not included in pharmacopoeias.

8.5.4. Stability monitoring

The establishment shall formulate the procedure and documents for monitoring of its drugs. These documents must be retained.

Chapter IX

DOCUMENTS

9.1. Rules

The establishment shall develop a system of documents, including quality handbooks, standards, procedures and regulations for all operations at the establishment.

9.2. General requirements

9.2.1. Documents must be designed, formulated, reviewed and distributed in a meticulous manner.

9.2.2. Documents must be approved, signed and dated by competent persons. Do not make any unauthorized change to a document.

9.2.3. Documents must contain understandable contents, all necessary information, a title, and information on their nature and purposes presented in an orderly and easy to inspect order, and no excessive data. Photocopies must be understandable and easy to read. Do not make any mistake when copying documents.

9.2.4. Regularly review and update documents. All amendments require official authorization. Take measures to prevent unintended use of old versions of amended documents. Replaced documents shall be retained for a suitable amount of time.

9.2.5. For documents requiring data input, the data inputted must be understandable, easy to read and indelible. The documents must have sufficient space for the data.

9.2.6. Any change to data in a document must be signed and dated; this change must not alter previous information (do not overwrite). Reason for such change must be recorded.

9.2.7. Documents shall be formulated or completed immediately when the relevant activities are carried out and in a manner that covers all activities related to product preparation to enable investigation into and tracing of defective products.

9.2.8. Preparation documents and retained samples of starting ingredients and finished products shall be kept for at least 1 year after the expiry date. Herbal ingredients shall undergo quality and stability assessment to determine retention period of their preparation documents and samples, which shall not be less than 1 year.

9.2.9. Preparation documents of semi-finished products used for multiple products must contain links to original documents for reference where necessary.

9.6. Procedures and records

9.6.1. Have SOPs and prepare records of each completed operation or conclusions for:

- Installation and appraisal of machinery and equipment;

- Analytical equipment and calibration thereof;

- Maintenance, cleaning and disinfection;

- Personnel-related matters, including qualifications, training, attire and hygiene;

- Environmental monitoring;

- Insect control;

- Complaints;

- Product recall;

- Returned products.

9.6.2. Have SOPs and prepare records of receipt of starting ingredients and primary packaging materials or pre-printed packaging. These records shall include:

- name of the raw material written on delivery sheet and container;

- internal name and/or code of the raw material (if any);

- date of receipt;

- name of supplier and, if possible, name of producer;

- batch number or reference number of producer;

- total weight and number of containers received;

- batch number assigned after receipt;

- any other relevant comment (e.g., state of container, etc.)

9.6.3. Have SOPs for labeling, special storage and storage of starting ingredients, packaging materials and other ingredients where appropriate.

9.6.4. Have SOPs and guidelines for sampling, which must specify the persons authorized to collect samples. The sampling guidelines shall include:

- sampling methods and sampling plans;

- sampling equipment;

- precautions against contaminating raw materials or degrading raw materials;

- required sample amount;

- guidelines for sample division where necessary;

- sample packaging and labeling;

- special precautions, especially for sampling of toxic raw materials.

9.6.5. Formulate a procedure describing the batch numbering system in detail for the purpose of ensuring that each batch of semi-finished products or finished products can be identified by a unique identifying number. This procedure must ensure that:

- batch numbers assigned during processing and during packaging are consistent with each other.

- a batch number is not used twice, which is also applicable to recycling;

9.6.6. Prepare SOPs and guidelines for appraisal, calibration, maintenance, use and cleaning of each type of equipment, which shall be placed near the relevant equipment. Such preparation shall be recorded in writing with specific date and name of in-charge persons.

Have procedures for approval for release or rejection of raw materials and products, especially for release of finished products to the market of authorized persons. Documents on distribution of each product batch must be retained in an orderly manner to facilitate searching where necessary.

Chapter X

PRODUCT COMPLAINTS AND RECALL AT ESTABLISHMENT

10.1. Product complaints

The establishment shall formulate written procedures for handling of all matters concerning complaints about its products and appoint personnel for transfer, consideration and assessment of complaints about products prepared by the establishment. Handling of a complaint shall be recorded in writing and retained until the expiry date of the product batch receiving the complaint.

10.2. Returned products

The establishment shall formulate documents on monitoring of and written procedures for receipt and inspection of returned products. Documents on returned products retained shall include product name and content, dosage form, batch number, reason for return, quality of returned product and return date. Returned products must be identified correctly and placed in isolated storage.

10.3. Product recall

The establishment shall formulate written procedures for handling of product recall and appoint persons to decide product recall. Documents and reports on product recall must be prepared and retained, including results of the recall and freezing of sale of released products. Recalled products shall be stored in a safe place to prevent them from being sold or used without investigation or assessment.