Tiêu đề 34 - Hướng dẫn của ASEAN và mỹ phẩm (ASEAN Guidelines for Cosmetic Good Manufacturing Practices).pdf ✅

ASEAN Cosmetic Documents Appendix VI – ASEAN Guideline for Cosmetic Good Manufacturing Practice 1 Appendix VI ASEAN Guidelines for Cosmetic Good Manufacturing Practice PREAMBLE The GMP Guidelines have been produced to offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN Cosmetic Directive. As this document is particularly intended for cosmetic products, clear delineation from drug or pharmaceutical product GMP should be kept in mind. The Good Manufacturing Practices presented here is only a general guideline for the manufacturers to develop its own internal quality management system and procedures. The important objective must be met in any case, i.e. the final products must meet the quality standards appropriate to their intended use to assure consumer’s health and benefit. 1. INTRODUCTION The objective of the Cosmetic Good Manufacturing Practice ( GMP ) guidelines is to ensure that products are consistently manufactured and controlled to the specified quality. It is concerned with all aspects of production and quality control. 1.1 General Consideration 1.1.1 In the manufacture of cosmetic products, overall control and monitoring is essential to ensure that the consumer receives products of specified quality. 1.1.2 The quality of a product depends on the starting materials, production and quality control processes, building, equipment and personnel involved.
ASEAN Cosmetic Documents Appendix VI – ASEAN Guideline for Cosmetic Good Manufacturing Practice 2 1.2 Quality Management System 1.2.1 A quality system should be developed, established and implemented as a means by which stated policies and objectives will be achieved. It should define the organisational structure, functions, responsibilities, procedures, instructions, processes and resources for implementing the quality management. 1.2.2 The quality system should be structured and adapted to the company’s activities and to the nature of its products and should take into consideration appropriate elements stated in this Guidelines. 1.2.3 The quality system operation should ensure that if necessary, samples of starting materials, intermediate, and finished products are taken, tested to determine their release or rejection on the basis of test results and other available evidence related to quality. 2. PERSONNEL There should be an adequate number of personnel having knowledge, experience, skill and capabilities relevant to their assigned function. They should be in good health and capable of handling the duties assigned to them. 2.1 Organisation, Qualification and Responsibilities 2.1.1 The organisational structure of the company shall be such that the production and the quality control sections are headed by different persons, neither of whom shall be responsible to the other. 2.1.2 The head of production should be adequately trained and experienced in cosmetic manufacturing. He should have authority and responsibilities to manage production of products covering operations, equipment, production personnel, production areas and records.
ASEAN Cosmetic Documents Appendix VI – ASEAN Guideline for Cosmetic Good Manufacturing Practice 3 2.1.3 The head of quality control should be adequately trained and experienced in the field of quality control. He should be given full authority and responsibility in all quality control duties such as establishment, verification and implementation of all quality control procedures. He should have the authority to designate/assign when appropriate, personnel, to approve starting materials, intermediates, bulk and finished products that meet the specification or to reject those which do not conform to the relevant specification or which were not manufactured in accordance with approved procedures and under the defined conditions. 2.1.4 The responsibilities and authority of key personnel should be clearly defined. 2.1.5 An adequate number of trained personnel should be appointed to execute direct supervision in each section of the production and the quality control unit. 2.2 Training 2.2.1 All personnel directly involved in the manufacturing activities should be appropriately trained in manufacturing operations in accordance to GMP principles. Special attention should be given to training of personnel working with any hazardous materials 2.2.2 Training in GMP should be conducted on a continuous basis. 2.2.3 Records of training should be maintained and its effectiveness assessed periodically. 3. PREMISES The premises for manufacturing should be suitably located, designed, constructed and maintained. 3.1 Effective measures should be taken to avoid any contamination from the surrounding environment and from pests. 3.2 Household products containing non-hazardous materials/ingredients and cosmetic products can share the same premises and equipment provided that due care should be exercised to prevent cross contamination and risk of mix-up. 3.3 Painted line, plastic curtain and flexible barrier in the form of rope or tape
ASEAN Cosmetic Documents Appendix VI – ASEAN Guideline for Cosmetic Good Manufacturing Practice 4 may be employed to prevent mix-up. 3.4 Appropriate changing rooms and facilities should be provided. Toilets should be separated fromthe production areas to prevent product contamination/cross contamination. 3.5 Defined areas should be provided for, wherever possible and applicable: 3.5.1 Materials receiving. 3.5.2 Material Sampling 3.5.3 Incoming goods and quarantine. 3.5.4 Starting materials storage. 3.5.5 Weighing and dispensing. 3.5.6 Processing. 3.5.7 Storage of bulk products. 3.5.8 Packaging. 3.5.9 Quarantine storage before final release of products. 3.5.10 Storage of finished products. 3.5.11 Loading and unloading. 3.5.12 Laboratories. 3.5.13 Equipment washing. 3.6 Wall and ceiling, where applicable should be smoothand easy to maintain. The floor in processing areas should have a surface that is easy to clean and sanitise. 3.7 Drains should be of adequate size and should have trapped gullies and proper flow. Open channels should be avoided where possible, but if required they should be able to facilitate cleaning and disinfection. 3.8 Air intakes and exhausts and associated pipework and ducting, when applicable, should be installed in such a way as to avoid product contamination.