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PH 112 - Pharmaceutical Analysis 2 (Lec) > PRELIM 01 - Review of Pharmaceutical Analysis > Flashcards

PRELIM 01 - Review of Pharmaceutical Analysis Flashcards

1
Q

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

A

Analytical chemistry

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2
Q

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

A

Qualitative method

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3
Q

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

A

Quantitative method

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4
Q

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

A

Assay

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5
Q

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

A

Quality assurance

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6
Q

Involves checking or testing that specifications are met

A

Quality control

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7
Q

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

A

Pharmaceutical analysis

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8
Q

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

A

Quality

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9
Q

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

A

ISO 9000

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10
Q

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

A

Six sigma

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11
Q

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

A

ISO 8402-1986

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12
Q

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

A

Quality assurance

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13
Q

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

A

Good manufacturing practice (GMP)

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13
Q

______________ 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)

A

Administration

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14
Q

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

A

Finance

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15
Q

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

A

Product planning (Business development)

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16
Q

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

A

Research and development

17
Q

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

A

Medical affairs

18
Q

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

A

Regulatory affairs

19
Q

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

A

Procurement and logistics

20
Q

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

A

Manufacturing/Production

21
Q

__________ 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)

A

Quality assurance

22
Q

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

A

Distribution

23
Q

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

24
Q

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

25
Q

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

A

Materials QA

26
Q

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

A

Analytical control laboratory

27
Q

Maintains presence of updated technical documents (Quality affairs functions)

A

Documentation

28
Q

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

A

GMP compliance

29
Q

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

A

Validation

30
Q

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

A

Stability testing

31
Q

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

A

Supplier quality management

32
Q

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

A

Complaints and recalls

33
Q

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

A

Analytical chemistry

34
Q

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

A

Qualitative method

35
Q

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

A

Quantitative method

36
Q

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

37
Q

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

A

Quality assurance

38
Q

Refers to the checking or testing that specifications are met

A

Quality control

39
Q

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

A

Pharmaceutical analysis

PH 112 - Pharmaceutical Analysis 2 (Lec) (9 decks)

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