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Cosmetic Good Manufacturing Practice of Cosmetic code of GMP October 1994 (THAILAND) 

Cosmetic Good Manufacturing Practice of Cosmetic code of GMP October 1994 (THAILAND)


  2. Definition
The following definitions are applicable :

 2.1 "Cosmetic" means cosmetic stipulated in Cosmetic Act B.E.2535.
 2.2 "Good Manufacturing Practice" is part of Quality Assurance aimed at ensuring that products are consistently manufactured to a previously specified quality. It is, thus, concerned with bulk materials and completely enclosing them.
 2.3 "Primary Packaging Materials" means packaging materials used in direct contact with bulk materials and completely enclosing them.
 2.4 "Secondary Packaging Materials" means packaging materials used in enclosing Primary Packaging Materials including labels and leaflets.
 2.5 "Label" means any figure, relief, or epithet pertaining to the cosmetics displayed on the cosmetic container, or package, or accompanying the cosmetic or inserted in the container or package, including the document or handbook provided with the cosmetic.
 2.6 "Batch or Lot" means a quantity of any cosmetic product produced in a given cycle of manufacture that is uniform in character and quality.
 2.7 "Lot Number and/or Control Number" means a designation in numbers and/or letters or combination of both that identifies the complete history of the batch quality control and distribution.
 2.8 "Date of Manufacture" means a fixed date of for the individual batch, indicating the starting date of manufacture.
 2.9 " Expiration Date or Expiry Date" means the time in which the preparation will remain stable when stored under recommended condition.
 2.10 "Raw Materials" means any formula infredient used in the manufacture of cosmetic product.
 2.11 "Bulk Product" means a cosmetic product which process is already complete however still need packaging stage to become finished product.
 2.12 "Finished Product" means a cosmetic product having passed all phases of manufactured and quality testing and ready for distribution.
 2.13 "Documentation" means all written records concerning the formula, all test results in quality testing of products and the recording of all test results and extraordinary occurences during the manufacture of a batch as well as the preservations of these records.
 2.14 "Master Formula" means the specific amount of raw materials for manufacturing.
 2.15 "Manufacturing" means all activities in the manufacture of a cosmetic product from the weighing-in of raw materials to processing, filling, packaging and labelling.
 2.16 "Production" means the entires series of activities which cover the processing and packaging.
 2.17 "Processing" means the entires series of activities from the weighing-in of raw materials up to obtaining the bulk product.
 2.18 "In-Process Control" means checks, tests and carried out in the course of the manufacture of cosmetic product.
 2.19 "Packaging" means the part of production cycle starting from bulk product filled into primary packaging material, labeled and packed that are ready for distribution.
 2.20 "Theoretical Yield" means the quantity that would be produced at any appropriate
 2.21 "Sterilization" means inactivating or reducing micro-organism by steam, dry heat, gas or ionizing radiation etc.
 2.22 "Clean Room or Clean Area" means a room or area with defined environment control of particular and microbial contamination, constructed, equipped and used in such a way as to reduce the introduction, generation and retention of contaminants. within the area.
 2.23 "Quality Assurance" means all activities of quality management made with the objective of ensuring that products will be of the quality which meet the required specification. It is Good Manufacturing Practice and Research and Development of the products.
 2.24 "Quality Control" means all efforts of examining and testing designed to ensure the uniform output of cosmetic products that conform to established specification of identity, strength and other characteristics.
 2.25 "Specification" means a requirements as to physical, chemical and biological characteristics of raw materials, bulk products and finished products.
 2.26 "Representative Sample" means a random sampling based on rational criteria and intended to assure that the sample accurately portrays the batch or the total amount of materials being sampled.
 2.27 "Quarantine" means the status of raw materials, packaging materials, bulk product and finished product which are physically separated by designation while waiting for decision.
 2.28 "Released or Passed" means the status of raw materials, packaging materials, bulk product and finished product which are allowed to be used for processing, packaging or distribution.
 2.29 "Rejected" means the status of raw materials, packaging materials, bulk product and finished product which are permitted to be used for processing, packaging or distribution.
 2.30 "Sanitation" means hygienic control on manufacturing including premises, personnel, equipment and material handling.
 2.31 "Research and Development" means carry out study, investigation, compile all data of cosmetic such as research on the quality of cosmetics in terms of physical, chemical toxicology and others that related to the quality assurance of cosmetic, including development of formulation and stability study.

3. Personnel

3.1 The organizational structure of the cosmetic manufacturers shall be such that production and quality control shall work independently. Duties and responsibility of each worker should be specified.
3.2 The head of each division shall be well trained and have practical experience inline with his/her duty.
3.3 All operating personnels of manufacture are to be trained in the principles of Good Manufacturing Practice, personal hyguene and operating precautions.
3.4 Provide an adequate number of technically trained personnel.
3.5 Physically and mentally healthy. They must be free from skin diseases, contagious diseases or open wound, and must have at least an annual physical check-up which record should be kept as reference.
3.6 All operating personnels involving in manufacture need to wear operating gown, shoes, gloves and mask suitable for the working process to be carried out when enter into the manufacturing area. Gown and shoes used in manufacturing area do not allow to be worn outside and should be washed regularly.

4. Premise

4.1 It should be in a appropriate location and clearly separated from living areas.
4.2 Building should be well designed and constructed in a suitable manner. It should contain enough area for manufacturing equipment. Floors, walls and ceilings should be durable, smooth, free from cracks, easy to clean and maintenance.
4.3 Provide enough light and good ventilation.
4.4 The manufacturing area is well protected from the intrusion of animals and insects.
4.5 Changing rooms, bathrooms and lavatories are adequately provided for all personnels.
4.6 Manufacturing rooms or filling rooms should have adequate space and appropriately furnished and not be used as entrance to the other area.
4.7 The raw material storing room is dry and clean. Temparature and humidity should be controlled as necessary.
4.8 The quarantine area is defined for raw materials, packaging materials, bulk products and finished products during quality control test.
4.9 Inflammable substances, explosive substances, toxic substances, packaging materials, bulk products and sub-standard finished products or recalled products are stored in specific areas.
4.10 The well equipped quality control unit is established as responsible entity for raw materials, bulk products and finished products.

5. Sanitation
Manufacturing premises shall be maintained in accordance with sanitary standard and cleanliness as followed:

5.1 The premises shall be kept tidy, clean, free from filth and vectors.
5.2 No unhygienic rule is allowed, e.g. eating food, smoking, storing food or beverages and storing things that are not related to cosmetics, in the premises.
5.3 Toilets and wash-basins shall be provided for workers. Toilets must be clean and have sufficient equipment for cleaning and disinfection as necessary.
5.4 Good provisions shall be established for controlloing fiflth, hazardous substances, polluted substances inclluding refuse, sediment or residue from those substances which are drained from the premises, which start or may start to affect environment quality or toxicity to public health in accordance with Enhancement and Conservation of National Environment Quality Act B.E.2535 (1992).
5.5 An adequate disposal of sewage disposal must be provided.
5.6 A proper draining system and filth draining system must be provided.
5.7 The following measures for safety must be established:

5.7.1 An adequate number of emergency exits for workers including exit-signposts which are easily seen.
5.7.2 Alarms of danger.
5.7.3 Appropriate number of fire-extinguishers or alternatives equipments for putting-out fire and also other fire-prevention methods.
5.7.4 Premises and necessary equipment to be used for First-Aid.

6. Equipment

6.1 Manufacturing equipments should be appropriate for operation. Design and Installation of equipments should be in such a way that:

6.1.1 minimize any contamination that may occur during manufacturing such as lubricants, dust or metal debris.
6.1.2 is easy to, thoroughly, clean equipment and installation area.
6.1.3 equipment material does not adsorb or react with or produce any contamination to the raw materials, cleansing agents and disinfections.
6.1.4 is suitable for its intended use and maintenance.


6.2 Equipments should be cleaned and disinfected before and after manufacture and should be kept in proper place.

7. Raw Materials and Packaging Materials

7.1 All received raw materials and packaging materials are recoreded. The record should contain informationd on date of receiving, name of materials, batch or lot number, name of supplier, manufacturer, quantity, date of analysis, date of release and date of expiration (if any).
7.2 They must not be harmful to health and conform to the quality specification.
7.3 They should be in good condition. The containers have no damage and contain detailed information on name, batch or lot number and quatity.
7.4 They are properly and separatedly stored to avoid any confusion, contamination and degradation due to temperature, humidity and sunlight. They are not placed directly on the floor, but the pallet.
7.5 They are quarantined while awaiting result of inspection and test from quality assurance unit. In addition, the label indicated their status, (released or rejected or awaiting for approval) are palced clearly on the container.
7.6 Approved raw materials and packaging materials is used in "first-in, First-out" order.
7.7 The stored remaining raw materials and packaging materials are retested periodically for quality assurance.
7.8 Measures of quality of water used in manufacturing process is established.

8. Production

8.1 Processing

8.1.1 Production process, which is reviewed by capabilities, is defined in written document to prevent err and contamination.
8.1.2 Raw materials are weighed with cross-checking in specific area.
8.1.3 Raw materials are kept in well closed and labeled container.
8.1.4 All equipments are cleaned and stored appropriately to avoid contamination.
8.1.5 The working area free from materials or equipments not required for current operation.
8.1.6 The prevention of contamination is put in place where a number of product items are produced in the same premises or a product item is produced in the premises that is priory used to produce another item.
8.1.7 Cosmetic products shall be examined and approved by quality control personnel prior to be released and distributed to the market.
8.1.8 bulk products shall be kept in well closed and labeled containers.

8.2 Packaging Each product item need Master Packaging Procedure which specifies packaging size and type of container.

8.2.1 Packaging materials of each product item shall be kept separatedly.
8.2.2 All labels and packaging materials shall be examined and approved by quality control personnel.
8.2.3 Filling and Labeling shall be recorded in Batch Processing Record that the product is examined and approved by quality control personnel.
8.2.4 Packaging materials and labeling shall be examined and recorded in document.
8.2.5 All cosmetic products shall bear the labels that comply with cosmetic regulations and be quarantined until examined and approved by quality control personnel.

9. Quality Control
The manufacturers shall assign quality control personnel with the following responsibilties:

9.1 establish and document quality control procedures including identification specification and test, chemical and physical properties, contamination of microorganisms of raw materials, bulk products and finished products.
9.2 acquire proper equipments for quality control performance.
9.3 establish sampling procedures for retaining and retain raw materials and finished products for retesting periodically.
9.4 retain, more than one year, finished products for at least two retest.
9.5 contain the authority to release raw materials, packaging materials and finished products.
9.6 define the date of expiration and storage of finished products from stability data if the date of expiration of raw materials defined.
9.7 examine the quality of raw materials and packaging materials.
9.8 participate in investigating the results on products due to the change of production process including equipments, procedures and rawmaterials.
9.9 establish measures for inspection of products when complaint.
9.10 evaluate the quality data of the defect products and establish the product recall procedure.
9.11 participate in the evaluation of the recalled products in association with other division.
9.12 record and retain the quality data of raw materials, packaging materials and finished products.

10. Documentation
The manufacturers shall document the written production enabling the precision of production in compliance with product specification as followed:

10.1 Master Formulas include

(1) product name;
(2) quality and quantity of total raw materials and packaging materials used;
(3) instruction of production, filling and storage of bulk products and finished products;
(4) theoretical yields and acceptable deviation;


10.2 Batch Documentation as the report of quality control of each batch as a statement of compliance with production specification including:

(1) product name, quantity and formula or item;
(2) manufacturing date and batch number;
(3) analytical number of all raw materials used in production;
(4) detail of production and equipments used;
(5) name and signature of operators;
(6) report of analytical data of production and modification;
(7) signature of person responsible for product release and date of approval;


10.3 Quality Control Report as the report of quality control of raw materials, packaging products, bulk materials and finished products.

(1) product name and quantity;
(2) manufacturing date and batch or lot number;
(3) analytical data;
(4) evaluation, summation and signature of quality control personnel;


10.4 Specification with the following informations:

(1) Raw Material Specification including:

- trade name and/or code
- chemical name
- name of manufacurer or distributor;
- specification including test for purification, chemical and physical properties and microbiological test (if necessary);
- frequency of retest of stored raw materials;
- date of expiration (if necessary);
- test of expired raw materials;
- special precaution e.g. explosive or inflammable raw materials etc.;
- date of issue;


(2) Packaging Material Specification including:

- trade name and/or code
- description of materials including thickness, width, colour and alphabet"s sharpness;
- name of manufacurer or distributor;
- special precaution (if necessary);
- date of issue;


(3) Bulk and Finished Products Specifications including:

- trade name and/or code
- preparation form and strength;
- physical properties e.g. colour, form, odor, quantity, acidity and viscosity etc.;
- chemical or microbiological test (if necessary);
- expiry date (if necessary);
- storage and special precaution (if necessary);
- date of issue;


10.5 Preservation of reports and Reference Samples

(1) document according to 10.2, 10.3 and 10.4 shall be retained for at least 2 yeasr.
(2) raw materials and finished products shall be retained as references in adequate quantity for retest when complaint.

11. Self Inspection

It is advisable for a manufacturer to appoint a properly qualified person or teamwork to conduct inspections of its overall premises and facilities, production, quality control procedure and other issues related to cosmetic manufacture.

12. Recalled Records

A manufacturer is responsible for recall of cosmetic products. The recall process must be able to be promptly performed and documented in the practical and understandable way.

13. Distribution Records

Manufacturer has to prepare distribution records of finished products in order to conduct a prompt accurate and efficient cosmetic recall whenever necessary.

14. Complaints and Reports of Cosmetic Allergy

Any complaints and reports from consumers regarding quality, safety and adverse effects of any cosmetic products must be thoroughly investigated and documented. If the cosmetic product is proven that it is out of specification or causes harmful side effects, it must be immediately recalled and destroyed.

15. Returned Products

A manufacturer should establish procedures for investigation and/or analysis of returned cosmetic products in order to determine whether such products should be reprocessed or destroyed.

References

1.       Thai Cosmetic Act B.E.2535

2.       Cosmetic Good Manufacturing Practice [GMP] of the Republic Indonesia, November 4, 1992.

3.       Food and Drug Administration, U.S. Department of Health and Human Services, Public Health Services: Cosmetic Handbook, February 28, 1991.

4.       GMP Regulations of Japan, 1992: Technical Guidelines for Manufacturing and Quality Control of Cosmetics.

5.       Principle of Cosmetic Licensing in Japan, 2ndedition.

6.       Good Manufacturing Practices [GMP] for cosmetic products published by Industrieverband Korperflege-und Waschmittel Karlstrabe 21, D-6000 Frankfurt am Main I, 1st edition July 1992.

7.       The Cosmetic, Toiletry and Fragrance Association, Inc., 1971: Quality Assurance Guidelines and Plant Housekeeping and cleanliness.

8.       Norman F. Estrin, The Cosmetic Industry, 1984.

9.       Thai Good Manufacturing Practices [GMP] for Pharmaceutical products B.E. 2530

10.    Thai Enhancement and Conversation of National Environment Quality Act B.E. 2535

11.    ASEAN Good Manufacturing Practice of Drug, 1981

12.    Remington Pharmaceutical Science 16th edition.