APPENDIX XI

• Document

  • ASEAN Cosmetic Documents
  • Appendix VI – ASEAN Guidelines for Cosmetic Good Manufacturing Practice
• The GMP Guidelines have been produced to offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN Cosmetic Directive
• 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 final products must meet the quality standards appropriate to their intended use to assure consumer’s health and benefit
• The objective of the Cosmetic Good Manufacturing Practice (GMP) guidelines is to ensure that products are consistently manufactured and controlled to the specified quality
• The quality of a product depends on the starting materials, production and quality control processes, building, equipment, and personnel involved
• Quality Management System


  1. A quality system should be developed, established and implemented as a means by which stated policies and objectives will be achieved

  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

  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
• There should be an adequate number of personnel having knowledge, experience, skill, and capabilities relevant to their assigned function
• Organisation, Qualification and Responsibilities

  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. The head of production should be adequately trained and experienced in cosmetic manufacturing

  3. The head of quality control should be adequately trained and experienced in the field of quality control
• Training


  1. All personnel directly involved in the manufacturing activities should be appropriately trained in manufacturing operations in accordance with GMP principles

  2. Training in GMP should be conducted on a continuous basis

  3. Records of training should be maintained and its effectiveness assessed periodically
• The premises for manufacturing should be suitably located, designed, constructed, and maintained
• Records of training


  • Should be maintained
  • Effectiveness should be assessed periodically
• Premises for manufacturing


  • Should be suitably located, designed, constructed, and maintained
• Effective measures to avoid contamination


  From the surrounding environment and from pests
• Household products containing non-hazardous materials/ingredients and cosmetic products

  Can share the same premises and equipment provided that due care is exercised to prevent cross-contamination and risk of mix-up
• Employed methods to prevent mix-up

  Painted line, plastic curtain, flexible barrier in the form of rope or tape
• Providing appropriate changing rooms and facilities


  Toilets should be separated from the production areas to prevent product contamination/cross-contamination
• Defined areas provided for

  • Materials receiving
  • Material Sampling
  • Incoming goods and quarantine
  • Starting materials storage
  • Weighing and dispensing
  • Processing
  • Storage of bulk products
  • Packaging
  • Quarantine storage before final release of products
  • Storage of finished products
  • Loading and unloading
  • Laboratories
  • Equipment washing
• Wall and ceiling should be

  Smooth and easy to maintain
• Floor in processing areas should have


  A surface that is easy to clean and sanitize
• Drains should be


  Of adequate size, have trapped gullies, and proper flow
• Air intakes, exhausts, pipework, and ducting should be


  Installed to avoid product contamination
• Buildings should be


  Adequately lit and properly ventilated appropriate to the operations
• Pipework, light fittings, ventilation points, and other services in manufacturing areas should be

  Installed to avoid uncleanable recesses and run outside the processing areas
• Laboratories should preferably be

  Physically separated from the production areas
• Storage areas should be

  Of adequate space, provided with suitable lighting, arranged and equipped to allow dry, clean, and orderly placement of stored materials and products
• Storage areas should be suitable for

  • Effective separation of quarantined materials and products
  • Storage of flammable and explosive substances, highly toxic substances, rejected and recalled materials or returned goods
  • Providing special storage conditions e.g. temperature, humidity, and security
  • Permitting separation of different labels and other printed materials to avoid mix-up
• Equipment should be


  • Designed and located to suit the production of the product
  • Equipment surfaces coming into contact with any in-process material should not react with or adsorb the materials being processed
  • Not adversely affect the product through leaking valves, lubricant drips, and through inappropriate modifications or adaptations
  • Easily cleaned
  • Used for flammable substances should be explosion-proof
• Equipment should be located to

  Avoid congestion and should be properly identified to assure that products do not become admixed or confused with one another
• Water, steam, pressure, or vacuum lines should be


  Installed to be easily accessible during all phases of operation and clearly identified
• Support systems such as heating, ventilation, air conditioning, water, steam, compressed air, and gases should

  Function as designed and be identifiable
• Weighing, measuring, testing, and recording equipment should be serviced and calibrated regularly. All records should be maintained
• Sanitation and hygiene should cover

  • Personnel
  • Premises
  • Equipment/apparatus
  • Production materials and containers
• Personnel should be


  Healthy
• Sanitation and hygiene practices


  • Personnel
  • Premises
  • Equipment and Apparatus
• Personnel


  1. Personnel should be healthy to perform their assigned duties

  2. Personnel must practise good personal hygiene

  3. Personnel with apparent illness or open lesions should not handle materials

  4. Personnel should report adverse conditions

  5. Direct physical contact with the product should be avoided

  6. Smoking, eating, drinking, and chewing not permitted in production areas

  7. Authorised personnel entering production areas should practice personal hygiene
• Premises


  1. Employee's washing and well-ventilated toilet facilities should be provided

  2. Suitable locker facilities for employees' clothing and belongings

  3. Waste material should be regularly collected

  4. Rodenticides, insecticides, fumigating agents, and sanitising materials must not contaminate equipment or products
• Equipment and Apparatus


  1. Equipment and utensils should be kept clean

  2. Vacuum or wet cleaning methods preferred over compressed air and brushes

  3. Standard operating procedures must be followed for cleaning and sanitising major machines
• Starting Materials


  1. Special attention should be paid to water as an important raw material

  2. Water systems should supply quality water and be sanitized

  3. Chemical and microbiological quality of water used in production should be monitored regularly

  4. Method for water treatment depends on product requirement

  5. Verification of materials for conformity to specifications and traceability

  6. Rejected materials should be segregated and disposed according to procedures