PRELIM 01 - Review of Pharmaceutical Analysis

Question 1

Chemistry that deals with the methods for determining the chemical composition of samples of matter

Answer 1

Analytical chemistry

Question 2

Yields information about the identity of atomic or molecular species (Methods of analytical chemistry)

Answer 2

Qualitative method

Question 3

Provide numerical information as to the relative amount of one or more of these components (Methods of analytical chemistry)

Answer 3

Quantitative method

Question 4

The process of a quantitative determination of a chemical substance from a given sample

Answer 4

Assay

Question 5

Refers to the sum total of the organized arrangements made with the object of ensuring that all APIs are of the quality required

Answer 5

Quality assurance

Question 6

Involves checking or testing that specifications are met

Answer 6

Quality control

Question 7

Is a branch of practical chemistry that involves a series of processes for identification, determination, quantification, and purification of a substance

Answer 7

Pharmaceutical analysis

Question 8

Refers to a measure of excellence or a state of being free from defects, deficiencies, and significant variations

Answer 8

Quality

Question 9

_____________ is a standard that sets the degree to which a set of inherent characteristics fulfills requirements

Answer 9

ISO 9000

Question 10

__________ refers to the “number of defects per million opportunities”

Answer 10

Six sigma

Question 11

__________ standard defines quality as the totality of features and characteristics of a product or service

Answer 11

ISO 8402-1986

Question 12

Is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product

Answer 12

Quality assurance

Question 13

A part of quality assurance which ensures that products are consistently produced and controlled to the quality standards

Answer 13

Good manufacturing practice (GMP)

Question 13

______________ determines the overall direction of the company and takes care of the day-to-day operations of the company (Organization of a pharmaceutical manufacturing company)

Answer 13

Administration

Question 14

__________ takes care of the financial processes necessary for the continuous operation of the company (Organization of a pharmaceutical manufacturing company)

Answer 14

Finance

Question 15

__________ conducts feasibility studies to determine the products that a company should manufacture and market (Organization of a pharmaceutical manufacturing company)

Answer 15

Product planning (Business development)

Question 16

__________ develops products to be marketed by the company (Organization of a pharmaceutical manufacturing company)

Answer 16

Research and development

Question 17

__________ takes care of the medical aspects of the products that will be marketed by the company (Organization of a pharmaceutical manufacturing company)

Answer 17

Medical affairs

Question 18

__________ liaises with the regulatory bodies on the registration of the company and its products (Organization of a pharmaceutical manufacturing company)

Answer 18

Regulatory affairs

Question 19

__________ purchases and stores the materials and products including services that will be used by the company (Organization of a pharmaceutical manufacturing company)

Answer 19

Procurement and logistics

Question 20

__________ converts raw and packaging materials into finished products for distribution and sale (Organization of a pharmaceutical manufacturing company)

Answer 20

Manufacturing/Production

Question 21

__________ ensures that the materials, products, and processes in the manufacture of the products are in accordance with the predetermined quality characteristics (Organization of a pharmaceutical manufacturing company)

Answer 21

Quality assurance

Question 22

__________ makes products physically available to the trade/customers (Organization of a pharmaceutical manufacturing company)

Answer 22

Distribution

Question 23

__________ creates the demand for the products (Organization of a pharmaceutical manufacturing company)

Answer 23

Marketing

Question 24

__________ fulfills the demand of the customers for the products (Organization of a pharmaceutical manufacturing company)

Answer 24

Sales

Question 25

Performs sampling, inspection, testing, evaluation, and release (Quality affairs functions)

Answer 25

Materials QA

Question 26

Conducts analytical testing of materials and products (Quality affairs functions)

Answer 26

Analytical control laboratory

Question 27

Maintains presence of updated technical documents (Quality affairs functions)

Answer 27

Documentation

Question 28

Conducts periodic GMP audits and self-inspection (Quality affairs functions)

Answer 28

GMP compliance

Question 29

Ensures that validation of facilities, equipment, and processes are efficiently done (Quality affairs functions)

Answer 29

Validation

Question 30

Performs the required stability tests for materials and products (Quality affairs functions)

Answer 30

Stability testing

Question 31

Ensures the proper qualification and maintenance of material and product suppliers (Quality affairs functions)

Answer 31

Supplier quality management

Question 32

Ensures that complaints and recall procedures are current and implemented efficiently (Quality affairs functions)

Answer 32

Complaints and recalls

Question 33

Chemistry that deals with the methods used for determining the chemical composition of states of matter

Answer 33

Analytical chemistry

Question 34

Yields information about the identity of atomic or molecular species or the functional groups in the sample (Methods of analytical chemistry)

Answer 34

Qualitative method

Question 35

Provides numerical information as to the relative amount of one or more of these components (Methods of analytical chemistry)

Answer 35

Quantitative method

Question 36

The process of a quantitative determination of a chemical substance from a given sample

Answer 36

Assay

Question 37

Refers to the sum total of organized arrangements made with the object of ensuring that all APIs are of the quality required for their intended use

Answer 37

Quality assurance

Question 38

Refers to the checking or testing that specifications are met

Answer 38

Quality control

Question 39

Is a branch of practical chemistry that involves a series of processes for identification, determination, quantification, and purification of a substance

Answer 39

Pharmaceutical analysis