Pcos Lec
Pcos Lec
The word ‘‘cosmetic’’ is derived from the Greek word Kosm tikos, ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING
meaning ‘‘having the power to arrange, skilled in decorating giving PRACTICE
kosmein, ‘‘to adorn,’’ and kosmos, ‘‘order, harmony’’, but the true
origin of cosmetics probably lies further still in antiquity, because The objective of the Cosmetic Good Manufacturing Practice ( GMP )
early cave paintings of 30,000 years ago depict the use of body Guidelines is to ensure that products are consistently manufactured
adornment (rudimentary cosmetics) in the rituals of mating and and controlled to the specified quality. It is concerned with all
hunting. aspects of production and quality control.
Throughout the recorded history of man, cosmetics have been used Quality Management System A quality system should be
with essentially the same three goals in mind, namely: developed, established and implemented as a means by which
1. to enhance personal appeal through decoration of the stated policies and objectives will be achieved. It should define the
body, organizational structure, functions, responsibilities, procedures,
2. to camouflage flaws in the integument, and instructions, processes and resources for implementing the quality
3. to alter or improve upon nature management.
Several historical vignettes showing the role of cosmetics down Personnel There should be an adequate number of personnel
through the ages: having knowledge, experience, skill and capabilities relevant to
o Vases of alabaster and obsidian for cosmetics discovered their assigned function. They should be in good health and capable
by Flinders Petrie in 1914 illustrate that the ancient of handling the duties assigned to them.
Egyptians were well versed in the use of eye and face
paints, body oils, and ointments Premises The premises for manufacturing should be suitably
o Theophrastus (363–278 BC), a student of Aristotle, located, designed, constructed and maintained.
demonstrated considerable knowledge of the
compounding of perfumes, Equipment Equipment should be designed and located to suit the
o The Roman physician, Galen of Pergamon (130–200 AD), production of the product.
is said to have innovated that time-honored toiletry: cold Design and Construction
cream (Cera Alba). Installation and Location
o The Babylonians were said by Herodotus (490–420 b.c.) Maintenance
to be well practiced in the use of depilatories and the eye
adornment. Sanitation and hygiene should be practiced to avoid
o Alexander the Great (356–323 b.c.) reported the use of contamination of the manufacturing of products. It should cover
unguents, incense, and other cosmetics by the countries of personnel, premises, equipment/apparatus and production
the Indo-Sumerian civilization. materials and containers.
Production
RAW MATERIALS USED IN COSMETICS Starting Materials
Batch Numbering System
The raw materials that are used in most cosmetics around the Weighing and Measurement
world are listed in the International Nomenclature of Cosmetic Procedure and Processing
Ingredients Dictionary. The latest edition of the INCI Dictionary has Dry Products
over 22,000 entries. Wet Products
Labelling and Packaging
In reality, those thousands of options can all be simplified and it has
come up that there are really only three types of cosmetic Starting Materials
ingredients. These include functional, aesthetic and claims. Water - Special Attention should be paid to water, since it
is an important raw material. Water production
equipment and water systems should supply quality
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water. Water systems should be sanitized according to REGULATORY ISSUANCE GOVERNING COSMETIC PRODUCT
well established procedures. NOTIFICATION
Verification of materials - All deliveries of raw materials
and packaging materials should be checked and verified The company or person responsible for placing the cosmetic
for their conformity to specifications and be traceable to products in the market must notify the regulatory authority
the product. responsible for cosmetics of each Member State where the product
Rejected materials - Deliveries of raw materials that do will be marketed, of the place of manufacture or of initial
not comply with specification should be segregated and importation before the product is placed in the market, using the
disposed according to standard operating procedures. Product Notification Form prescribed by the regulatory authority.
Batch Numbering System The product can only be marketed after notification has been sent
Every finished product should bear a production to the regulatory authority and acknowledgement has been
identification number which enables the history of the received
product to be traced.
A batch numbering system should be specific for the Aiming to streamline the process by updating the submission of
product and a particular batch number shall not be application requirements from the previously manual form to
repeated for the same product in order to avoid confusion online submissions, the Food and Drug Administration (FDA)
allowed online application process.
Dry Products
Handling of dry materials and products should be given This modernization was kickstarted in March 2013 through FDA
special attention. Where possible, dust-containing Memorandum Circular No. 2013-011.
production system, central vacuum system or other
suitable methods should be employed.
What Information should be Declared in the Product Notification?
Wet Products ◉ Brand Name/Product Name/Product Variants
The used of closed systems of production and transfer is ◉ Product Type
recommended. ◉ Particulars of the Product
◉ Intended Use
Labelling and Packaging ◉ Product Presentations
Packaging line should be inspected for clearance prior to ◉ Local Company Responsible for Placing the Cosmetic Product in
operation. Equipment should be clean and functional. All the Market
materials and products from previous packaging ◉ Establishment Information
operation should have been removed. ◉ Person Representing the Local Company
Samples should be taken and checked at random during ◉ Product Ingredient List
labelling and packaging operations.
Each labelling and packaging line should be clearly Procedures in the Application for Cosmetic Product
identified to avoid mix up. Notification in the Philippines
o The application process has four (4) main parts:
o Submission
ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING o Payment
PRACTICE o Download Result, and
o Revalidation
Quality Control
Quality control is an essential part of GMP. It provides assurance APPLICATION PROCESS
that cosmetic products will be of consistent quality appropriate to 1. Submission:
their intended use. o This is now done through the FDA’s portal at
Reprocessing https://www.fda.gov.ph
Returned Products o Once you have filled up the necessary details of the
cosmetic product to be notified, you can submit the
application with the FDA through their portal.
Internal Audits
An internal audit may be conducted by outside or independent
2. Payment
specialists or a team designated by the management for this
o Filing fee depends on the number of years of the validity
purpose. Such audits may also be extended to suppliers and
of the registration.
contractors, if necessary.
3. Download Results
o There are instances when the FDA will send an email
Storage
Storage areas should be of sufficient capacity requiring additional documents or information
Storage areas should be designed or adapted to ensure concerning the application.
good storage conditions. o Compliance with the email by submitting the required
documents or supplying the needed information is a
requisite to the FDAs approval of the notification.
o On the other hand, the failure to comply with the
additional documents or information required will lead to
the rejection of the application for notification.
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4. Revalidation
o Acknowledged cosmetic notifications may be revalidated
for a new validity date, where the new validity date will
be based on the date of submission of the revalidation
application.
Hair Color
o All natural hair colors are the result of two types of hair ANATOMY OF HAIR
pigments. I- THE SHAFT
o Both of these pigments are Melanin types, produced A- The medulla
inside the hair follicle and packed into granules found in B- The Cortex
the fibers. C- The cuticle
o Eumelanin is the dominant pigment in brown hair, and
black hair while pheomelanin is dominant in red hair.
II- THE ROOT
A- The hair bulb
Normal scalp hair growth patterns B- The erector pili muscles
o Average total number of scalp hairs is 100,000 hairs.
o Average rate of growth is 0.35 mm/day. HAIR SHAFT
o Hair grows faster in summer than in winter. There are 3 main layers of the hair shaft.
o Average daily loss is 25-100 hairs /day. 1. CUTICLE: The outermost layer of the hair. It consists of a
o Fastest growth is between 15-30 years. single layer of transparent, scale like cells that overlap
like shingles on a roof. A healthy, compact cuticle layer is
o Female hair grows faster than male hair.
the hair’s primary defense against damage.
2. CORTEX: The middle layer of hair; a fibrous protein core
formed by elongated cells containing melanin pigment.
TYPES OF HAIR
About 90 percent of hair weight comes from the cortex.
o Vellus (lanugo) hair: short, fine, downy, unpigmented hair
Protein structures located in the cortex provide hair
on body. elasticity. Changes resulting from chemical services occur
o Terminal hair: long, thick, pigmented hair found on scalp, in the cortex.
legs, arms, and body. 3. MEDULLA: Innermost layer; also referred to as the
pith(Core) of the hair. It is composed of round cells. Very
fine and naturally blonde hair may not even have a
SHAPES OF HAIR medulla. Thick, coarse hair and beard hair always contain
The shape of the hair shaft determines whether hair is straight or a medulla.
curly.
o If the shaft is round, the hair is straight.
o If the shaft is oval, the hair is wavy. HAIR LIFE CYCLE
o f the shaft is flat, the hair is curly or kinky. There are 3 phases in the hair life cycle. “Hair shedding usually
occurs in the transition phase, but can also occur in the resting
phase.”
Transition Phase (CATAGEN): lasts one or two weeks & hair follicle
shrinks about 80%.
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Resting Phase (TELOGEN): After five or six weeks, dermal papilla h) Thickening agents
reconnects to base of hair follicle and bloodstream. The hair re- i) Sequestering Agents
enters the active-growth phase and a new hair begins to from.
1. PATCH TEST
a test for determining allergic sensitivity that is made by
applying to the unbroken skin small pads soaked with the
allergen to be tested
The 48-hour patch test allows the assessment of the
primary irritation potential of a topical product.
The test is conducted on a panel of at least 25 subjects.
The patches used can be occlusive or semi-occlusive
depending on the nature of the product.
3. NON-COMEDOGENIC TEST
a test to evaluate the skin condition before and after one
month of product usage. The evaluator counts the number
of comedons and blackheads on the forehead, cheeks and
chin.
Alternatively, a non-comedogenic claim can be assessed
via a microscopic examination of the skin after application
of patches containing the product.
4. NON-ACNEGENIC TEST
a test to evaluate skin condition before and after one
month of product usage. The evaluator counts the number
of acne lesions (papules and pustules) on the forehead,
cheeks and chin.
SPECIFIC INGREDIENTS
SODIUM FLOURIDE USP:
Maximum Permitted Concentration of Fluoride in
Properties:
toothpaste for
Occurs as a white, odorless powder which is soluble in
o OTC sales – 0.15%
water and insoluble in alcohol
o Pharmacies – 1.3%
Uses:
Officially used as dental prophylactic The Probable Toxic Dose (PTD) of fluoride, 5 mg F/kg of
2% aqueous sol’n is widely used topically. Usual body weight.
procedure is a series of 4 treatments: beginning at the age
of 3; ages 7, 11 and 13 as the permanent teeth erupts SAFETY PRECAUTIONS:
Package size & especially, fluoride contents be controlled.
STANNOUS FLOURIDE USP Supervised toothpaste use by preschool children
Synonym: Tin Diflouride Manufacturers should be encouraged to include this
Properties: advice in labels.
Stannous fluoride occurs as a white crystalline powder
and has a bitter salty taste. It melts at about 213 degrees CHRONIC TOXICITY
Celsius;
Freely soluble in water; insoluble in alcohol, ether and
chloroform
Uses:
extensively used for topical fluoride application
o A simple application of a freshly prepared 8%
solution at 6 to 12 months intervals is used
it requires only 1 application per treatment as compared
to a series of 4 application per treatment of NaF
o solution is applied to a cleaned, dry teeth.
PUMICE USP
Synonym: Pumice Stone; Piedra Pomez
Properties:
substance of volcanic origin; consisting chiefly of complex
silicates of aluminum, potassium and sodium
occurs as very light, hard, rough, porous grayish masses,
or as a gritty gray powder
Pumice is odorless and tasteless; stable in air; practically
insoluble in water and is not attacked by acids.
Uses: Dental Abrasive
GRADES OF FINENESS:
1. Pumice flour or superfine
2. Fine Pumice
3. Coarse pumice