Lessons 1- 3 Overview, GMP, E-notifications

Question 1

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.

Answer 1

Cosmetic Science

Question 2

Cosmetic science encompasses the discipline of:

Answer 2

chemistry, Physics, Biology and
Pharmacy.

Question 3

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

Answer 3

Cosmetics

Question 4

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.

Answer 4

20th century

Question 5

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

Answer 5

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

Question 6

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

Answer 6

1991, the Cosmetics Directive was amended for the sixth time

Question 7

the most important aspect of cosmetic science is?

Answer 7

chemistry

Question 8

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

Answer 8

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

Question 9

are the ones that provide the benefit of cosmetics.

Answer 9

Functional ingredients

Question 10

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

Answer 10

Aesthetic ingredients

Question 11

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

Answer 11

Claims ingredients (sometimes
called fairy dust)

Question 12

Future of cosmetic science:

Answer 12

3D Printing cosmetics
Epigenetics
Microbial cleansing
Sustainable resources

Question 13

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

Answer 13

Quality Management System

Question 14

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

Answer 14

Quality control

Question 15

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

Answer 15

INTERNAL AUDITS

Question 16

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,

Answer 16

cosmetic product notification

Question 17

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

Answer 17

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

Question 18

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

Answer 18

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

Question 19

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.

Answer 19

True

Question 20

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

Answer 20

True

Question 21

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

Answer 21

Water

Question 22

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

Answer 22

False
answer: at random

Question 23

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

Answer 23

Batch

Question 24

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

Answer 24

Batch Number

Question 25

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

Answer 25

Bulk Product

Question 26

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

Answer 26

Calibration

Question 27

Date of manufacturing of a batch of product. Date of Production Date of Manufacture Production Date Manufacturing Time

Answer 27

Date of Manufacture

Question 28

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

Answer 28

Documentation

Question 29

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

Answer 29

Product

Question 30

A product which has undergone all stages of manufacturing operations. Finished Product Starting Materials Product Formulation

Question 31

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.

Answer 31

In-Process Control

Question 32

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

Answer 32

In-Process Control

Question 33

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.

Answer 33

Manufacture or Manufacturing

Question 34

The part of production cycle applied to a bulk product to obtain the finished product. Packaging Material Packaging Processing In-Process Control

Answer 34

Packaging

Question 35

Any material used in the packaging of a bulk product to obtain the finished product. Packaging Material Packaging Raw Materials Starting Materials

Answer 35

Packaging Material

Question 36

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

Answer 36

Processing

Question 37

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

Answer 37

Production

Question 38

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

Answer 38

Quality Control

Question 39

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

Answer 39

Quarantine

Question 39

Any ingredient to be used in the formulation of a cosmetic product. Packaging Material Packaging Raw Materials Starting Materials

Answer 39

Raw Materials

Question 40

The status of materials or products which are not permitted to be used for processing, packaging or distribution. Rejected Released Returned Product Starting Materials

Answer 40

Rejected

Question 41

The status of materials or products which are allowed to be used for processing, packaging or distribution. Rejected Released Returned Product Starting Materials

Answer 41

Released

Question 42

Finished products sent back to the manufacturer. Returned product Finished product Starting Materials Raw Materials

Answer 42

Returned Product

Question 43

Hygienic control on manufacturing premises, personnel, equipment and material handling. Specification of Materials Sanitation Quarantine Quality Control

Answer 43

Sanitation

Question 44

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

Answer 44

Specification of Materials

Question 45

Raw materials and packaging materials used in the production of products. Starting Materials Raw Materials Intermediate materials Bulk product

Answer 45

Starting Materials

Question 46

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

Answer 46

Cosmetic Product Notification

Question 47

4 Main parts of E-notification Application Procedure:

Answer 47

Submission >> Payment >> Download result >> Revalidation