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Manufacture Lecture > PQS > Flashcards

PQS Flashcards

1
Q

Quality management is a _________-range concept

A

Wide

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2
Q

The SUM TOTAL of the organized arrangements

A

Quality management

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3
Q

Quality management incorporates

A

GMP

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4
Q

It is necessary to assure that products are manufactured with DESIRED QUALITY and PERFORMANCE

A

PQS

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5
Q

Are subject to strict regulations

A

Operations of the pharmaceutical industry

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6
Q

It serves people DIRECTLY for HEALTH REASONS

A

Operations of the pharmaceutical industry

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7
Q

Needs to be RELIABLE on various parameters

A

Pharmaceutical field produce

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8
Q

Who emphasizes the adoption of QMS

A

Quality experts

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9
Q

It is the VAGUE CONCEPT of QA

A

PQS

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10
Q

Has the ultimate responsibility to ensure an effective PQS

A

Senior management

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11
Q

PQS should be

A

Defined and documented

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12
Q

Contains a DESCRIPTION of QMS and MANAGEMENT RESPONSIBILITIES

A

Quality manual

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13
Q

A part of quality management that ensures products are CONSISTENTLY PRODUCED

A

GMP

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14
Q

GMP is concerned with both

A

Production and quality control

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15
Q

The manufacturing company cannot produce drugs without it

A

Personnel

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16
Q

Concerned with SAMPLING, SPECIFICATIONS and TESTING

A

Quality control

17
Q

Ensure that the necessary and relevant tests are CARRIED OUT

A

Quality control

18
Q

Cause of deviations in QC

A

SAMPLING in every steps

19
Q

Should be conducted with the objective of VERIFYING the CONSISTENCY of the process

A

Regular periodic quality reviews

20
Q

A systematic process for the assessment, control, communication and review of RISKS to the quality

A

Quality risk management

21
Q

The evaluation of the risk to quality is based on

A

Scientific knowledge
Experience with the process
Patient’s protection

22
Q

Commensurate with the level of risks

A

Level of effort
Formality
Documentation of QRM process

23
Q

No problem but there’s management

A

Proactive

24
Q

With problem and management

A

Retrospective

Manufacture Lecture (4 decks)

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