Cgmp

• In July 1997, the ASEAN Cosmetic Association officially asked the ASEAN Secretariat and the ASEAN Consultative Committee on Standards and Quality for help in removing barriers to cosmetics, specifically by harmonising technical regulations governing the cosmetic industry in ASEAN
• Since then ASEAN cosmetic regulators and the cosmetic industry in the ASEAN region have been working together to address the issues associated with barriers
• The Agreement on the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS) was signed


  September 2, 2003
• The AHCRS lays down the requirements for cosmetic products for all signatory ASEAN Member Countries starting from January 1, 2008
• ASEAN Cosmetic Directive (ACD)

  An agreement among ASEAN countries to harmonise requirements of cosmetic products so as to reduce technical barriers (created by standards, technical regulations and conformity assessment) to trade in the region
• The ACD aims to


  Eliminate technical barriers to trade of cosmetic products without compromising public health and safety to the ASEAN population through the harmonization of technical requirements
• 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
• Quality Management System


  • 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
  • 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
• Personnel


  • Adequate number of qualified people with practical experience
  • An individual's responsibilities should not be so extensive as to present a risk to quality
  • Key personnel (normally full time) positions include: Head of Production, Head of Quality Control
• Head of Production


  Responsible for approval or rejection of materials, packing materials, intermediates, bulk and finished products, evaluation of batch records, carrying out of necessary testing, approval of quality control procedures such as sampling instructions, specifications, test methods, and other QC procedures, approval and monitoring of all contract analysis, maintenance of quality laboratory, including equipments and laboratory apparatus, calibration of control equipments, initial and continuous training of QC personnel
• Head of Quality Control


  Responsible for approval or rejection of materials, packing materials, intermediates, bulk and finished products, evaluation of batch records, carrying out of necessary testing, approval of quality control procedures such as sampling instructions, specifications, test methods, and other QC procedures, approval and monitoring of all contract analysis, maintenance of quality laboratory, including equipments and laboratory apparatus, calibration of control equipments, initial and continuous training of QC personnel
• Personnel Training


  • 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
  • Training in GMP should be conducted on a continuous basis
  • Records of training should be maintained and its effectiveness assessed periodically
• Premises


  • The premises for manufacturing should be suitably located, designed, constructed and maintained
• Floors


  • Solid concrete for warehouse
  • Solid concrete with epoxy or polyurethane resin finish is suitable for processing areas as it has a non-porous topping with non skid surface and retards bacterial growth
  • Equivalent materials can be floor tiles with proper cleaning and sanitizing procedure
• Walls & Ceilings


  • Block structural wall of high density, smoothly plastered, waterproofed by painting with acrylic or high polymer enamel
  • Cement boards
• Joints & Frames


  • The design of joints and frames should be such that cleaning and sanitation can be done easier
• Changing Room


  • Store working shoes separately
  • Keep gowns in cabinet to avoid dirt and dust
  • Soap for hand cleaning must be installed near the sink. Paper towels or hand drier should be provided whichever is suitable
• Loading & Unloading


  • Goods received and dispatched at the docks, bays, platforms or areas should be protected from dust, dirt and rain
• Storage Area


  • Storage areas should be of sufficient capacity to allow orderly storage of various categories of materials and products with proper segregation
  • Status labeling of materials should be observed
• Storage Area


  • Storage of toxic substance
  • Printed packaging materials
  • Returned / recalled products
• Flammable Warehouse


  • Preferably, alcohol and flammable warehouse can be located in a separate location, with good ventilation, fenced, locked, using explosion proof installation
  • Applicable to national laws
  • This warehouse should be indicated by inflammable and sufficient safety signs
• Quarantine & Rejected Areas

  • Any system replacing physical quarantine should be given an equivalent security
  • Reject area should be kept under lock and key
• Sampling Booth


  • Sampling should be conducted in such a way to prevent cross contamination
• Weighing & Dispensing


  • The weighing of starting materials should be carried out in a separate weighing area designed for that use, complete with provisions for dust control
• Processing Area


  • Adequate working space should permit the orderly & logical positioning of equipment and materials to minimize the risk of confusion, avoid cross contamination and reduce the risk of omission or wrong application of any of the manufacturing or control steps
• Processing Area Interior


  • Smooth, cleanable, easy to maintain and impervious to chemicals or cleaning materials
  • Covings where floor meets walls may be observed
  • Recessed light fittings where appropriate
• Minimum requirements for processing area interior include: light with cover, no coving with proper cleaning procedure
• What should be avoided in processing area interior: light without cover, coving without proper cleaning procedure
• Packaging Area


  • Premises for filling/ packaging should be designed and laid out to avoid mix-ups or cross contamination
• QC Laboratory


  • QC lab should be designed to suit intended operations
  • There should be adequate storage space for samples, reference standards, solvents, reagents & records
• Washing & Cleaning Tools

  • Washing area
  • Cleaning tools area
• Utility Storage


  • A storage area for clean equipment used for production should be provided
• Storage of Clean & Idle Equipment

  • A separate room may be needed for storing clean, idle equipment which should be kept dry at all times
  • Proper storing of hoses allowing them to dry should also be observed to prevent retention of liquid
• Sample of factory layout showing material flow through plastic door, finished products, personnel, packaging materials, raw/bulk materials
• Equipment Design & Construction

  • Surfaces must not be reactive, additive or absorptive
  • Easily & conveniently cleanable
  • Must not affect the product through leaking valves, inappropriate maintenance, etc.
  • Must use explosion proof materials for the manufacture of flammable substances
• Fixed Pipelines


  • Fixed pipelines for the transfer of products and materials should be designed to avoid product contamination and mix-ups
  • Water, steam, pressure and vacuum lines where applicable should be installed
• Storage areas


  • Bulk storage
  • Label storage/coding area
  • Quarantine area
  • Reject area
  • Sampling
  • Approved raw material
  • Receiving
• Material flow through plastic door to finished products
• Surfaces


  • Must not be easily & conveniently cleanable
  • Must not affect the product through leaking valves, inappropriate maintenance, etc.