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Good Manufacturing Practice (GMP)

A good manufacturing practice (GMP) refers to the production and testing practice that not only safeguards the wellbeing of the customer but also ensures the production of standard good quality cosmetic products.

A cosmetic product which has become adulterated cannot be sold to the public.  There are essentially four reasons for a cosmetic product to end up adulterated:

  1. It may be injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance.
  2. It contains microbes.
  3. It contains a non-permitted, or in some instances non-certified, colour additive or restricted substance.
  4. It is manufactured or held under insanitary conditions where it may have become injurious to users or contaminated with microbes.

A cosmetic product’s packaging must also comply so GMP also covers:

  1. False or misleading labelling.
  2. Failure to state prominently and conspicuously any information required by or under authority of EU cosmetics regulation 1223/2009.
  3. Misleading container presentation or fill.

ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products.  Under EU cosmetics regulation 1223/2009, it is not a legal requirement to follow ISO 22716:2007, however you are required to demonstrate your own system achieves the same objective as that of the ISO 22716:2007 GMP guidelines.

Rigorous adherence to good manufacturing practice minimises the risk of adulteration or misleading packaging of cosmetic products. The following cosmetic establishment instructions serve as guidelines for effective self-inspection. A good inspection score means that an establishment follows good manufacturing practice.  Following these guidelines will achieve the same objective as that of the ISO 22716:2007 GMP guidelines.  A comparison table of international GMP standards can be found below.

Guidelines

  1. Premises: Building and Facilities. Check whether
    1. Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.
    2. Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair.
    3. Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk.
    4. Lighting and ventilation are sufficient for the intended operation and comfort of personnel.
    5. Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.
  2. Equipment. Check whether:
    1. Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitising agent.
    2. Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitised at appropriate intervals.
    3. Cleaned and sanitised portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination.
  3. Personnel. Check whether:
    1. The personnel supervising or performing the manufacture or control of cosmetics have the education, training and/or experience to perform the assigned functions.
    2. Persons coming into direct contact with cosmetic materials, finished products in bulk or cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garments, gloves, hair restraints etc., and maintain adequate personal cleanliness.
    3. Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas.
  4. Raw Materials. Check whether:
    1. Raw materials and primary packaging materials are stored and handled in a manner which prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture.
    2. Containers of materials are closed, and bagged or boxed materials are stored off the floor.
    3. Containers of materials are labeled with respect to identity, lot identification and control status.
    4. Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms.
    5. Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetic products.
  5. Production. Check whether manufacturing and control have been established and written instructions, i.e., formulations, processing, transfer and filling instructions, in-process control methods etc., are being maintained. Determine whether such procedures require that:
    1. The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition.
    2. Only approved materials are used.
    3. Samples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microorganisms or chemical contaminants, and compliance with any other acceptance specification.
    4. Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified.
    5. Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information.
    6. Labels are examined for identity before labeling operations to avoid mix-up.
    7. The equipment for processing, holding, transferring and filling of batch is labeled regarding identity, batch identification and control status.
    8. Packages of finished products bear permanent code marks.
    9. Returned cosmetic products are examined for deterioration or contamination.
  6. Laboratory Controls. Check whether:
    1. Raw materials, in-process samples and finished products are tested or examined to verify their identity and determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants.
    2. Reserve samples of approved lots or batches of raw materials and finished products are retained for the specified time period, are stored under conditions that protect them from contamination or deterioration, and are retested for continued compliance with established acceptance specifications.
    3. The water supply, particularly the water used as a cosmetic ingredient, is tested regularly for conformance with chemical-analytical and microbiological specifications.
    4. Fresh as well as retained samples of finished products are tested for adequacy of preservation against microbial contamination which may occur when reasonably used within foreseeable conditions of storage, and consumer use.
  7. Records. Check whether control records are maintained of:
    1. Raw materials and primary packaging materials, documenting disposition of rejected materials.
    2. Manufacturing of batches, documenting the:
      1. Kinds, lots and quantities of material used.
      2. Processing, handling, transferring, holding and filling.
      3. Sampling, controlling, adjusting and reworking.
      4. Code marks of batches and finished products.
    3. Finished products, documenting sampling, individual laboratory controls, test results and control status.
    4. Distribution, documenting initial shipment, code marks and consignees.
  8. Labelling. Check whether the labels of the immediate and outer container bear:
    1. The name of the product and the statements of identity and net contents.
    2. The name and address of the manufacturer of the product.
    3. The INCI list of ingredients.
    4. The allergens declaration required by EU cosmetics regulation 1223/2009.
    5. Any other warning statement necessary or appropriate to prevent a health hazard. Determine the health hazard or their basis for a warning statement.
    6. Any direction for safe use of product.
    7. In case of a hair dye product, the caution statement and appropriate directions for preliminary patch testing.
  9. Complaints. Check whether the firm maintains a consumer complaint file and determine:
    1. The kind and severity of each reported injury and the body part involved.
    2. The product associated with each injury, including the batch code number.
    3. The medical treatment involved, if any, including the name of the attending physician.
    4. The name(s) and location(s) of any poison control center, government agency, physician’s group etc., to whom formula information and/or toxicity data are provided.
  10. Other. Check whether the firm is:
    1. Participating in the program of voluntary registration via the Cosmetic Products Notification Portal (CPNP).
    2. Using a colour additive which is not listed for use in cosmetics or which is not certified.
    3. Using a prohibited cosmetic ingredient.

How the above FDA-compliant guidelines correlate to other international GMP standards:

QUALITY AND SAFETY REQUIREMENT

GUIDELINES ABOVE

ISO 22716:2007

COLIPA (1995)

ASEAN (2003)

 The Cosmetics Quality Management System and Organisation

Clauses

3, 6, 7

Clauses

3, 9, 15, 17

Clauses

1, 2, 5

Clauses

1, 2, 7, 8

 Premises and Equipment

Clauses

1, 2

Clauses

4, 5

Clause

1

Clauses

3, 4

 Product Realisation and Materials Management

Clauses

4, 5, 8

Clauses

6, 7, 8, 11, 12

Clauses

2, 3, 4

Clauses

5, 6, 10, 11

 Deviations, Complaints and Recalls

Clause

9

Clauses

10, 13, 14

Clause

5

Clauses

12, 13

 Continuous Improvement

~

Clause

16

~

Clause

9