LAS 1

Question 1

Any component which is intended to furnish PHARMACOLOGICAL ACITIVTY

Answer 1

Active ingredient

Question 2

A quantity of drug product/device that is homogenous in character and quality produced during a given cycle of manufacturing

Answer 2

Batch

Question 3

A designation of number or letter or combination thereof that identifies the batch

Answer 3

Batch number

Question 4

ANY MATERIAL INTENDED TO BE USED FOR THE MANUFACTURER OF A PRODUCT, whether raw materials or packaging materials

Answer 4

Component

Question 5

intended to be rubbed, poured, sprinkled, or otherwise applied to the human body or any part thereof, for cleansing and beautifying

Answer 5

Cosmetics

Question 6

The date INDICATING THE START OF BATCH PROCESS

Answer 6

Date of manufacture

Question 7

The activity of weighing, counting, or measuring and checking of starting materials and issuing these materials to the appropriate production personnel

Answer 7

Dispensing

Question 8

Any substance/s in a finished dosage form that IS OFFERED FOR SALE

Answer 8

Drug product

Question 9

A product that has undergone ALL STAGES OF MANUFACTURING OPERATIONS.

Answer 9

Finished product

Question 10

A date fixed for each individual batch on or before which that batch is expected to meet the standard specifications for quality, safety, and efficacy

Answer 10

Expiration date

Question 11

It is the SYSTEM OF QUALITY ASSURANCE aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use.

Answer 11

Good Manufacturing Practices

Question 12

Any processed substance or mixture of substances which have to undergo a few step before finished product

Answer 12

Intermediate product

Question 13

a batch or any portion of a batch of a drug or, in the case of a drug produced in a unit of time or quantity in a manner that assures its uniformity and quality within specified limits

Answer 13

Lot

Question 14

The COMPLETE set of activities to produce a drug

Answer 14

Manufacturing

Question 15

It is an INSTRUCTION TO PRODUCTION to produce a drug

Answer 15

Manufacturing order

Question 16

The standard from where manufacturing order is derived

Answer 16

Master Formula

Question 17

The process of packaging

Answer 17

Packaging

Question 18

The description of the operations to be executed

Answer 18

Procedures

Question 19

The part of the production cycle from weighing of raw materials to finished product

Answer 19

Processing

Question 20

All control measures designed to ensure that finished products consistently condor, to established specification of identity, purity, strength and quality

Answer 20

Quality control

Question 21

An act of holding off material for use; Pending a decision on release or rejection

Answer 21

Quarantine

Question 22

All substances whether active or excipients that are employed in the processing of a finished product

Answer 22

Raw materials

Question 23

The status of materials or products which are NOT PERMITTED to be used for processing, packaging or distribution

Answer 23

Rejected

Question 24

The status of materials or products which are PERMITTED to be used processing, packaging or distribution

Answer 24

Accepted

Question 25

a SAMPLE REPRESENTING the lot, the batch, or the total amount of materials based on a sampling plan

Answer 25

Representative sample

Question 26

Any finished product which is already in distribution and sent back to the manufacturer or distributor due to a complaint.

Answer 26

Returned products

Question 27

Raw materials used in the production

Answer 27

Starting materials

Question 28

the quantity that is EXPECTED to be obtained at any phase of production based on the quantity of components

Answer 28

Theoretical yield

Question 29

Any processed material which has to undergo another process including packaging operation to become a finished product

Answer 29

Bulk product