Non-governmental members of the board of directors are entitled to a remuneration prescribed by the Ministry of Health. The registration period, registration fee and registration renewal fee shall be prescribed by the Board of Directors. A person whose registration of a traditional drug has been revoked must follow the instructions of the authority's committee in relation to the traditional drug in his possession.
The work in the office of the Board of Authority will be carried out by the Department of Traditional Medicine.
QUALITY MANAGEMENT
The organizational structure of the company must be such that production and the quality control department are independent of each other. Good manufacturing practice training must be conducted in accordance with written programs approved by the head of the production department and the head of the quality control department.
PREMISES AND EQUIPMENT
The production of other traditional medicines and health supplements will be done in separate facilities. Production areas should be well lit, especially where on-line visual checks are performed. Separate areas will be used for the production of finished products intended for external use or application and finished products intended for internal consumption only.
There must be separate and secure areas for the storage of rejected, recalled or returned materials or products. Reception areas must be designed and equipped so that containers with incoming materials can be cleaned where necessary before storage. If sampling is carried out in the storage area, it must be carried out in such a way as to prevent contamination or cross-contamination.
Particular attention should be paid to the cleanliness and good maintenance of storage areas, especially when dust is generated. Control laboratories are designed to suit the activities carried out in them. Production equipment must be located at such a distance from other equipment as to prevent overcrowding and cross-contamination.
SANITATION AND HYGIENE
Premises used for the manufacture of products must be of suitable design and construction to facilitate good sanitary conditions. Adequate employee washrooms and well-ventilated toilet facilities and changing rooms must be provided in suitable locations. Adequate locker facilities must be provided in appropriate locations for the storage of employees' clothing and personal belongings.
The preparation, storage and consumption of food and drink must be limited to special areas such as dining rooms and canteens. Equipment and supplies must be cleaned inside and out after use in accordance with established procedures. Compressed air and brushes should be used with caution or avoided if possible as they increase the risk of product contamination.
There must be sufficient space, preferably separated from processing areas, for cleaning and storage of mobile equipment and tools, including storage of cleaning materials. Written procedures must be established and followed for cleaning and disinfecting equipment, tools and containers used in the manufacture of traditional medicines and dietary supplements. Records of cleaning, including appropriate disinfection and inspection carried out prior to use, must be maintained.
DOCUMENTATION
Any change made to the entry on a document must be signed and dated, and where appropriate the reason for the change must be noted. Any Quality Control documentation relating to a batch record must be retained for at least one year after the expiry date of the finished product. Documented traceability of the materials and suppliers is fundamental to the quality of the finished products and will be made available.
A description of the packaging operation, including any significant additional operations, and equipment to be used;. It will be based on the relevant parts of the Manufacturing Formula and currently approved processing instructions. It will be based on the relevant parts of the packaging instructions and the method of preparation of these records will be designed to avoid transcription errors.
date(s) and time of packing; when there is a risk of contamination, the packing activity should be done on the same day. Details of packaging procedures carried out, including reference to equipment and packaging lines used; Records are kept of the distribution of each batch of product to facilitate recall of the batch if necessary.
PRODUCTION
At every stage of processing, products and materials must be protected against microbial and other contamination. Significant changes to the facilities, equipment and the processes that may affect the quality of the product must be verified. Contamination of a starting material or of a product by another material or product must be avoided.
The supplier of the material must be adequately assessed and the assessment must be recorded. Packaging material will only be issued for use by authorized personnel according to an approved and documented procedure. The name and batch number of the product being handled must be displayed at each packing station or line.
Measures should be taken to prevent any contaminants such as glass shards and metal particles. Finished products are kept in quarantine until final release under conditions specified by the manufacturer. After release, finished products are stored as usable stock under conditions specified by the manufacturer.
QUALITY CONTROL
The stability of the finished product is monitored according to an ongoing appropriate program that will enable the detection of any stability problems associated with the formulation in the marketed package. Reference samples are representative of the batch of materials or products from which they are taken. Samples of input materials (excluding solvents, gases and water) should be kept for at least two years after product release, if their stability permits.
Laboratory reagents intended for prolonged use must be marked with the date of preparation and the signature of the person who prepared them. After marketing, the stability of the product will be monitored according to an appropriate continuous program that will allow the detection of any stability problems related to the formulation in the marketed package. The ongoing stability program will be described in a written protocol and the results will be formalized as a report.
Equipment used for an ongoing stability program (including stability chambers) must be qualified and properly maintained. For example, an ongoing stability study is conducted after any significant change or significant deviation from a procedure or package. The results of ongoing stability studies are made available to key personnel and in particular to an authorized person.
CONTRACT MANUFACTURE AND ANALYSIS
The client provides the contractor with all information necessary to correctly carry out the contracted work, in accordance with the requirements of the NRA. The client ensures that all products and materials supplied by the contractor meet its specifications. The contractor has adequate buildings, equipment, knowledge and experience and competent staff to carry out the work assigned by the client in a satisfactory manner.
The Contractor shall ensure that all products or materials received are fit for their intended purpose. The contract recipient shall refrain from any activity that may adversely affect the quality of the product manufactured/tested for the contract grantor. A contract will be drawn up between the contract grantor and the contract acceptor, which specifies their respective responsibilities regarding the production and control of the product.
In the case of contract analysis, the contract must specify whether or not the contractor must take samples from the manufacturer. The contract must allow the contractor to visit the contract acceptor's facilities. In the case of contract analysis, the contract acceptor must understand that he is subject to inspection by the competent authorities.
COMPLAINTS AND PRODUCT RECALLS
In particular, other groups containing reworks of the defective batch will be investigated. All decisions and measures taken as a result of a complaint will be recorded and referred to the corresponding batch records. For recurring problem, a trend will be established to identify the possible systemic defects.
Responsibility and procedures for the recall of the product will be established by the manufacturer to facilitate the recall of a batch from any link of the distribution chain when it becomes necessary. The procedures to be followed must be specified in writing and made known to all who may be involved. There will be established written procedures, regularly reviewed and updated when necessary, to organize any recall activity.
The distribution records must be readily accessible to the person(s) responsible for recalls and must contain sufficient information about the distributor/importer/retailer/wholesaler and direct supplied customers (with recent and valid addresses, contact numbers including mobile phone, telephone and/or fax numbers within and outside working hours, lots and quantities delivered), including those for exported products. Recalled products must be identified, recorded and stored separately in a secure area while awaiting a decision on their fate. Progress in the recall process must be recorded and a final report issued, including a reconciliation of the delivered and recovered quantities of the products.
SELF-INSPECTION
Disclaimer: In case of any discrepancies, reference should be made to the official definition of health supplements from the ASEAN Agreement on Traditional Medicine / Health Supplements. Re-inspection is carried out if there are significant changes to facilities, systems, processes and equipment that could affect the quality of the finished products and the changes would require regulatory approval. If there are no significant changes, regular inspections should be carried out to demonstrate that the facilities, systems, processes and equipment continue to meet the prescribed requirements.
Verification of process contributes to the assurance of product quality and the basic principle of quality assurance is that a product must be manufactured under such a condition as is suitable for its intended use. The basic principle of quality assurance is that a product must be consistently manufactured and controlled to the quality standards appropriate for their intended use and as required by the marketing authorization and product specification. A process verification report must be prepared to provide evidence that the process has been verified. a) Demonstration.
Critical parameters must be determined and monitored. During production, checks are carried out to monitor the process and adjust it if necessary to ensure that the products meet specifications. The likely impact of the change of facilities, systems and equipment on the product must be evaluated, including risk analysis. The necessity and extent of re-inspection of machinery and equipment and re-inspection of processes must be determined.
