GMP Guidlines/Inspections
Buiiding & Facilities - Check whether
Buildings used in the manufacture or storage of products are of suitable size, design
and construction to permit unobstructed placement of equipment, orderly storage
of materials, sanitary operation, and proper cleaning and maintenance.
Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces
and are kept clean and in good repair.
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.
Lighting and ventilation are sufficient for the intended operation and comfort of
personnel.
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
Equipment - Check whether
Equipment and utensils used in processing, holding, transferring and filling are
of appropriate design, material and workmanship to prevent corrosion, build up of
material, or adulteration with lubricants, dirt or sanitizing agent.
Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained
and clean and are sanitized at appropriate intervals.
Cleaned and sanitized 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.
Personnel - Check whether:
The personnel supervising or performing the manufacture or control of products has
the education, training and/or experience to perform the assigned functions.
Persons coming into direct contact with raw materials, finished products in bulk
or product contact surfaces, to the extent necessary to prevent adulteration of
products wear appropriate outer garments, gloves, hair restraints etc., and maintain
adequate personal cleanliness.
Consumption of food or drink, or use of tobacco is restricted to appropriately designated
areas.
Raw Materials - Check whether:
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.
Containers of materials are closed, and bagged or boxed materials are stored off
the floor.
Containers of materials are labelled with respect to identity, lot identification
and control status.
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 animal or vegetable origin and those used in the manufacture
of products by cold processing methods with respect to contamination with filth
or microorganisms.
Materials not meeting acceptance specifications are properly identified and controlled
to prevent their use in products.
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:
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.
Only approved materials are used.
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.
Weighing and measuring of raw materials is checked by a second person, and containers
holding the materials are properly identified.
Major equipment, transfer lines, containers and tanks are used for processing, filling
or holding products are identified to indicate contents, batch designation, control
status and other pertinent information.
Labels are examined for identity before labelling operations to avoid mix-up.
The equipment for processing, holding, transferring and filling of batch is labelled
regarding identity, batch identification and control status.
Packages of finished products bear permanent code marks. Returned products are examined
for deterioration or contamination.
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Labelling - Check whether
Whether the labels of the immediate and outer container bear:
a. On the principal display panel
In addition to the name of the product, the statements of identity and net contents,
The statement "Warning--The safety of this product has not been determined" if the
safety of the respective product has not adequately been substantiated. Determine
whether and what toxicological and/or other testing the firm has conducted to substantiate
the safety of its products
b. On the information panel :
The name and address of the firm manufacturing the product or introducing it into
interstate commerce.
The list of ingredients (only on outer container) if intended for sale or customarily
sold to consumers for consumption at home.
Any warning statement necessary or appropriate to prevent a health hazard. Determine
the health hazard or their basis for a warning statement.
Any direction for safe use of product.
Laboratory Controls - Check whether:
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.
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.
The water supply, particularly the water used as a cosmetic ingredient, is tested
regularly for conformance with chemical-analytical and microbiological specifications.
Fresh as well as retained samples of finished products are tested for adequacy of
preservation against microbial contamination which may occur user reasonably foreseeable
condition of storage and consumer use.
Records - Check whether
control records are maintained of:
Raw materials and primary packaging materials, documenting disposition of rejected
materials.
Manufacturing of batches, documenting the:
Kinds, lots and quantities of material used.
Processing, handling, transferring, holding and filling.
Sampling, controlling, adjusting and reworking.
Code marks of batches and finished products.
Finished products, documenting sampling, individual laboratory controls, test results
and control status.
Distribution, documenting initial interstate shipment, code marks and consignees.
The firm maintains a consumer complaint file and determine:
The kind and severity of each reported complaint.
The product associated with each complaint, including the manufacturer and code
number.
The medical treatment involved, if any, including the name of the attending physician..
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.
The firm is:
Participating in the program of any voluntary registration
Using a colour additive which is not listed for use.
Using a prohibited ingredient.
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