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Cosmetics > Lessons 1- 3 Overview, GMP, E-notifications > Flashcards

Lessons 1- 3 Overview, GMP, E-notifications Flashcards

1
Q

An area which studies the
development of products designed to bring improvement the look and feel of
skin, hair, nails and other surface of the body.

A

Cosmetic Science

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2
Q

Cosmetic science encompasses the discipline of:

A

chemistry, Physics, Biology and
Pharmacy.

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3
Q

Any product that you put on your body for the specific purpose of improving the appearance or feel.

Used for the purpose of beautifying, perfuming, cleansing, or rituals

A

Cosmetics

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4
Q

Century that a great
progress had been made in the diversification of products and functions and in the safety and protection of the consumer in using such products.

A

20th century

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5
Q

ensure the free circulation of cosmetic products & improve the safety of cosmetic products by placing the
responsibility of the product on the cosmetic manufacturer.

A

Council Directive 76/768/EEC of
27 July 1976 on

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6
Q

prohibited the marketing of cosmetic products containing ingredients or
combinations of ingredients tested on
animals, as of 1998.

A

1991, the Cosmetics Directive was amended for the sixth time

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7
Q

the most important aspect of cosmetic science is?

A

chemistry

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8
Q

The raw materials that are used in most cosmetics around the world are listed in the

A

International Nomenclature of Cosmetic
Ingredients Dictionary. INCI Dictionary has over 22,000 entries

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9
Q

are the ones that provide the benefit of cosmetics.

A

Functional ingredients

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10
Q

are those that help make delivery of the functional ingredients more acceptable.

A

Aesthetic ingredients

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11
Q

are ingredients added to a formula at a low level for the primary purpose of getting to put the ingredient name on the label.

A

Claims ingredients (sometimes
called fairy dust)

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12
Q

Future of cosmetic science:

A

3D Printing cosmetics
Epigenetics
Microbial cleansing
Sustainable resources

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13
Q

should be developed, established and implemented as a means by which stated policies and objectives will be achieved.

A

Quality Management System

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14
Q

an essential part of GMP. It provides assurance that cosmetic products will be of consistent quality appropriate to their intended use.

A

Quality control

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15
Q

consists of an examination and assessment of all or part of a quality system with the specific purpose of improving it.

A

INTERNAL AUDITS

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16
Q

notify the regulatory authority responsible for cosmetics of each Membe State where the product will be marketed, of the place of manufacture or of initial importation before the product is placed in the market,

A

cosmetic product notification

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17
Q

FDA regulates cosmetics under this law, cosmetics must not be adulterated or misbranded.

A

Federal Food, Drug and Cosmetic Act (FD&C Act).

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18
Q

T or F
The quality of a product depends only on the production and quality control processes, and personnel involved.

A

False
Answer: The quality of a product depends on the starting materials, production and quality control processes, building, equipment and personnel involved.

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19
Q

T or F
Sanitation and hygiene should be practised to avoid contamination of the manufacturing of products. It should cover personnel, premises, equipment/apparatus and production materials and containers.

A

True

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20
Q

T or F
Direct physical contact with the product should be avoided to ensure protection of the product from contamination.

A

True

21
Q

it is an important raw material, could be treated by deionisation, distillation or filtration

A

Water

22
Q

T or F
Samples should be taken and checked orderly during labelling and packaging operations.

A

False
answer: at random

23
Q

A quantity of any cosmetic product produced in a given cycle of manufacture that is uniform in character and quality.

Batch
Batch Number
Finished Product
Product

A

Batch

24
Q

A designation in numbers and/or letters or combination of both that identifies the complete history of the batch, quality control and distribution.

Batch
Batch Number
Finished Product
Product

A

Batch Number

25
Q

Any processed product which will have to undergo the packaging operation in order to become a finished product.

Product
Bulk Product
Finished Product
Starting Materials

A

Bulk Product

26
Q

Combination of checking an instrument and adjusting it to bring it within its limits for accuracy according to recognized standards.

Measuring
Documentation
Calibration
Weighing

A

Calibration

27
Q

Date of manufacturing of a batch of product.

Date of Production
Date of Manufacture
Production Date
Manufacturing Time

A

Date of Manufacture

28
Q

All written procedures, instructions and records involved in the manufacture and quality control of products.

A

Documentation

29
Q

Any substance or preparation intended to be used, or capable or purported or claimed to be capable of being used, in or for cleansing, improving, altering or beautifying the complexion, skin, hair or teeth.

Finished Product
Starting Materials
Product
Formulation

A

Product

30
Q

A product which has undergone all stages of manufacturing operations.

Finished Product
Starting Materials
Product
Formulation

A
31
Q

In-Process Control
Checks and tests instituted and carried out in the course of the manufacture of a
product including checks and tests done on environment and equipment in order
to ensure that the end product will comply with its specification.

A

In-Process Control

32
Q

Checks and tests instituted and carried out in the course of the manufacture of a product including checks and tests done on environment and equipment in order to ensure that the end product will comply with its specification.

Quality Management System
In-Process Control
Quality Control
Process documentation

A

In-Process Control

33
Q

The complete set of activities to produce a product, comprising of production and quality control, from acquisition of all raw materials through processing and subsequent packaging and release for distribution of the finished product.

A

Manufacture or Manufacturing

34
Q

The part of production cycle applied to a bulk product to obtain the finished product.

Packaging Material
Packaging
Processing
In-Process Control

A

Packaging

35
Q

Any material used in the packaging of a bulk product to obtain the finished product.

Packaging Material
Packaging
Raw Materials
Starting Materials

A

Packaging Material

36
Q

The part of production cycle starting from weighing of raw materials to obtaining a bulk product.

Packaging
Production
Processing

A

Processing

37
Q

All operations starting from processing to packaging to obtain a finished product.

Packaging
Production
Processing

A

Production

38
Q

All measures taken during manufacturing which are designed to ensure the uniform output of product that will conform to established specifications.

Packaging
Production
Processing
Quality Control

A

Quality Control

39
Q

The status of materials or products set apart physically or by system, while awaiting a decision for their rejection or release for processing, packaging or distribution.

Isolation
Quarantine
Isolation
Segregation

A

Quarantine

39
Q

Any ingredient to be used in the formulation of a cosmetic product.

Packaging Material
Packaging
Raw Materials
Starting Materials

A

Raw Materials

40
Q

The status of materials or products which are not permitted to be used for processing, packaging or distribution.

Rejected
Released
Returned Product
Starting Materials

A

Rejected

41
Q

The status of materials or products which are allowed to be used for processing, packaging or distribution.

Rejected
Released
Returned Product
Starting Materials

A

Released

42
Q

Finished products sent back to the manufacturer.

Returned product
Finished product
Starting Materials
Raw Materials

A

Returned Product

43
Q

Hygienic control on manufacturing premises, personnel, equipment and material handling.

Specification of Materials
Sanitation
Quarantine
Quality Control

A

Sanitation

44
Q

A description of a starting material or finished product in terms of its chemical, physical and biological characteristics, if applicable. A specification normally includes descriptive and numerical clauses stating standards and tolerated deviations.

Starting Materials
Raw Materials
Specification of Materials
Intermediate materials

A

Specification of Materials

45
Q

Raw materials and packaging materials used in the production of products.

Starting Materials
Raw Materials
Intermediate materials
Bulk product

A

Starting Materials

46
Q

ASEAN Harmonized Cosmetic Regulatory Scheme in 2005 by virtue of DOH Administrative Order No. 2005-0015 and 2005-0025, the notification scheme for cosmetics was implemented

A

Cosmetic Product Notification

47
Q

4 Main parts of E-notification Application Procedure:

A

Submission&raquo_space; Payment&raquo_space; Download result&raquo_space; Revalidation

Cosmetics (10 decks)

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