QC MANUFACTURING CONTROL

Question 1

Determines the material type, assembly, special properties and integrity

Answer 1

Packaging Test

Question 2

Limiting test test substance: Arsenic <211>

Answer 2

Diethythiocarbamate

Question 3

Limiting test test substance: Heavy metals <231>

Answer 3

Hydrogen sulfide TS

Question 4

Limiting test test substance: Iron <241>

Answer 4

Ammonium thiocyanate

Question 5

Limiting test test substance: Ca, Na, C <197>

Answer 5

Flame photometry

Question 6

SO4

Answer 6

Barium chloride TS

Question 7

Limiting test test substance: Lead<251>

Answer 7

Ammonia-cyanide solution TS, Thioacetamide TS

Question 8

This determines the conformance of dosage form when compared to label claim; this may be instrumental, chemical or biological.

Answer 8

Assay

Question 9

This is the test of properties, functionalities of particular dosage forms

Answer 9

Dosage form-specific tests

Question 10

This monitors the production process and reduces the risk of substandard quality to ensure that all aspects of contractual obligations are met

Answer 10

In-Process Quality control / In process Control

Question 11

This is done to satisfy product identity, purity, safety, quality, and strength

Answer 11

Control tests

Question 12

A type of airflow that has varying velocity or nonparallel direction

Answer 12

Non-unidirectional airflow

Question 13

An airflow that has a single direction

Answer 13

Unidirectional airflow

Question 14

The process that verifies (HEPA) and (ULPA) filters are properly installed, that there is an absence in leakage of the filter installation

Answer 14

Dispersed oil particulate test

Question 15

The minimum particle collection efficiency of this filter is 99.9997% for particles greater than or equal to 0.12 micron size.

Answer 15

Ultra low penetration air

Question 16

The minimum particle collection efficiency of this filter is 99.97–9 9.997% for particles Off 0.3 µm particle

Answer 16

High efficiency particulate air

Question 17

What are the class a WHO requirements?

Answer 17

– Preparation of solution solutions for aseptic filling.
– Depyrogenisation Of containers.
– Filling of aseptic process

Question 18

What is the class B WHO requirement

Answer 18

– Background for the sterile Class a zone.

Question 19

What what are the class C WHO requirements?

Answer 19

– Clean areas for less practical activities for preparation of solution for terminal sterilization
– Filling of terminal sterilization

Question 20

What is the class D WHO requirement?

Answer 20

– Clean areas for less critical activities, for instance, washing of containers.

Question 21

It is an environment where the particular contamination in bacterial contamination are limited the prescribed levels

Answer 21

Clean room

Question 22

It can occur from variety of sources such as poor hygiene, practices, improper, cleaning of equipment and the use of shared production facilities

Answer 22

Cross contamination

Question 23

A distribution of drugs that minimize any risk to their quality

Answer 23

CGMP principle

Question 24

A comparison making due allowance for normal variation between the amount of product or materials theoretically and actually produced or used

Answer 24

Reconciliation

Question 25

This require control limits based on previous record and or validation

Answer 25

Yield control

Question 26

How many percent is usual for dry products?

Answer 26

95 to 100%

Question 27

How many percent is usual for liquids?

Answer 27

95 to 102.5 percent

Question 28

How many Percent is usual for capsules?

Answer 28

90 to 100%

Question 29

For herbal capsules

Answer 29

85 to 100%

Question 30

This shows identification, correct materials and equipment use this is also Used to ensure absence of foreign matter

Answer 30

Line clearance

Question 31

It is a unique digit three segment number And present on all non-prescription and prescription medication packages

Answer 31

National drug code

Question 32

It means a specific amount Produced in a unit time or according to a single manufacturing order during the same cycle of manufacture

Answer 32

Batch

Question 33

It means a portion of a batch or a combination of batches

Answer 33

Lot

Question 34

This is an accurate reproduction of the master formula record

Answer 34

Batch reproduction record

Question 35

This is the prototype document used as the key in the manufacturer of products

Answer 35

Master formula record

Question 36

A document generated to explain in detail the reason behind the procedure and proper sequence of steps to be done and how equipment are to be operated for a maximum performance

Answer 36

Standard operating procedures

Question 37

This document provides the basis for accepting the quality of each and every component use in the manufacture of the product in accordance with the specifications and methods

Answer 37

Quality control monograph

Question 38

The basis document from where the master formula and batch production records are based

Answer 38

Manufacturing monograph

Question 39

This means any distinctive combination of marketing letters or numbers by which the history of the manufacture and control of a batch or a lot of a product can be determined

Answer 39

Batch number or lot number

Question 40

This is a step-by-step description of all significant aspects of the process

Answer 40

Manufacturing process

Question 41

10 min break

Answer 41

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