Exercise 1

• Cosmetics are substances intended to be placed in contact with various external parts of the human body for cleaning, perfuming, changing appearance, etc.
• Examples of cosmetics include shampoos, conditioners, shower gels, shaving creams, toothpaste, mouthwash, hair dyes, and depilatory products
• In the Philippines, cosmetics are intended to be rubbed, poured, sprinkled, sprayed, or applied to human body parts for cleansing, beautifying, promoting attractiveness, or altering appearance
• Legal control of the manufacture of cosmetics includes regulations like A.O. no. 90 s. 2002, A.O. no. 2005-0015, A.O. no. 2005-0025, Bureau Circular No. 2006-017, and FDA Memorandum Circulars
• A.O. no. 90 s. 2002:

  • CGMP Guidelines for Cosmetic Products
  • Objective: Assist the cosmetic industry in compliance with the harmonized ASEAN Cosmetic Regulatory Scheme
  • Effective Date: Jan 1, 2003
• A.O. no. 2005-0015:

  • Adoption of ASEAN Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents
  • Objective: Adopt and incorporate the ASEAN Harmonized Regulatory Scheme into National Requirements
  • Important Dates: Date signed: Sept. 2, 2003; Date of Issuance: April 21, 2005
• A.O. no. 2005-0025:

  • Implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents
  • Objective: Provide implementing details for the incorporation of ASEAN Cosmetics Directive into Philippine requirements
  • Assist BFAD in strengthening post-market surveillance system
• Bureau Circular No. 2006-017:

  • Amendment to B.C. 2006-001 for the submission of Application for Notification, Registration, and Export of Cosmetic Products
• FDA Memorandum Circulars include guidelines on CCRR User Account, Electronic Notification of Cosmetic Products, and updates on the ASEAN Cosmetic Directive
• The ASEAN Cosmetics Directive covers aspects like personnel, premises, equipment, sanitation, hygiene, production, quality control, documentation, internal audits, storage, and more
• In the manufacture of cosmetic products, overall control and monitoring are essential to ensure specified quality for consumers
• Personnel involved in manufacturing activities should be appropriately trained in accordance with GMP principles
• Premises where cosmetics are made should be well-lit, properly ventilated, and measures should be taken to avoid contamination
• Laboratories should be physically separated from production areas
• Defined areas should be provided for:

  • Materials receiving
  • Materials 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
• Ceramic tiles can be allowed for floors or walls if gaps between tiles can be properly cleaned and sanitized to prevent microbial contamination
• Equipment should be designed and located to suit product production
• Weighing, measuring, testing, and recording equipment should be serviced and calibrated regularly
• Specific areas are used for different processes
• Personnel should be healthy and practice good personal hygiene
• Washing and locker facilities for employees should be provided
• Waste material should be regularly collected
• Standard operating procedures must be followed for cleaning and sanitizing major machines
• The minimum water quality standard required is the national drinking water standard
• Water chemical and microbiological quality should be monitored regularly
• All deliveries of raw materials and packaging materials should be checked and verified for conformity
• Every finished product should bear a production identification number
• All manufacturing procedures should be carried out according to written procedures
• All required in-process controls should be carried out and recorded
• Cleaning between batches is to prevent contamination; continuous manufacturing without cleaning can be allowed with proof of no contamination
• Packaging line should be inspected for clearance prior to operation
• All finished products should be approved by Quality Control prior to release
• Quality Control ensures cosmetic products are of consistent quality
• If a company lacks a QC facility, testing can be outsourced to an external accredited laboratory
• The documentation system should record all executed activities related to GMP
• If an error is made on a document, it should be corrected without losing the original entry
• All specifications should be approved by authorized personnel
• Master formula should be available upon request
• Batch manufacturing records should be prepared for each batch product
• An internal audit aims to improve the quality system