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Pharmaceutical Manufacturing > Finals > Flashcards

Finals Flashcards

1
Q

Systemic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding.

A

Quality by Design (QbD)

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2
Q

Crucial in pharmaceutical manufacturing .

A

Regulatory Landscape

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3
Q

Fundamental in Qbd. Identifying and mitigating potential risk in manufacturing process is key to maintaining product quality and safety.

A

Risk Assessment

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4
Q

Involves the establishment of ranges process.

A

Design Space

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5
Q

Essential for managing variability and ensuring product quality.

A

Control Strategy

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6
Q

Enables real-time monitoring and control of manufactiring processes.

A

Process Analytical Technology (PAT)

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7
Q

Vital in pharmaceutical manufacturing. By continously evaluating and optimizing processes, manufacturers can achieve enhanced efficiency and product quality.

A

Continous Improvement

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8
Q

Paramount in optimizing pharmaceutical manufacturing.

A

Leveraging advanced technology

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9
Q

Integral to optimizing pharmaceutical manufacturing.

A

Supply Chain

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10
Q

Pivotal in pharmaceutical manufacturing.

A

Resource optimization

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11
Q

The embraced of QbD principles has a profound

A

Global Impact

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12
Q

The future of pharmaceutical manufacturing is shaped by the continous evolution of QbD principles.

A

Future Perspectives

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13
Q

Pivotal in optimizing pharmaceutical manufacturing

A

Quality by Design

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14
Q

Crucial for successful validation.

A

Regulatory Requirements

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15
Q

Key step in the validation process. It should include detailed plans for

A

Qualification, Process Performance Qualification (PPQ) and Continued Process Verification

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16
Q

Essential to identify and mitigate potential risk in the manufacturing process.

A

Risk Assessment

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17
Q

Throughout the validation process is critical.

A

Data Integrity

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18
Q

Essential to maintain the accuracy and reliability of data.

A

Data management system and ISO guidelines principle

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19
Q

Stage involves demonstrating that the manufacturing process consistently producess product meeting predetermined specifications.

A

Process Performance Qualification (PPQ)

20
Q

Essential provide evidence of compliance with regulatory requirements.

A

Validation Documentation

21
Q

Ensuring that personnel are adequately trained and qualified to perform validation actvities is crucial.

A

Training and Qualifications

22
Q

Essential in maintaing validated process.

A

Continous Improvement

23
Q

Intiatives contribute to ongoing compliance and quality enhancement.

A

Quality Reviews and Process Optimization

24
Q

Crucial in demontrating compliance with regulatory requirements.

A

Audits and Inspections

25
Q

“The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

A

Process Validation (defined by FDA)

26
Q

During this staged based on knowledge gained through development and scale up activities.

A

Stage 1 - Process Design (PD)

27
Q

During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

A

Stage 2 - Process Qualification (PQ)

28
Q

Ongoing Assurance is gained during routine production that the process remains in a state of control.

A

Stage 3 - Continous Process Verification (CVP)

29
Q

Validation is an extension of the concepts of quality assurance since close control of the process is necessary.

A

Assurance Quality

30
Q

The optimization of a process for maximum efficiency, while maintaing quality standards, is a consequence of validation.

A

Process Optimization

31
Q

Quality cost are divided in to four categories.

A

Preventive Cost
Appraisal Cost
Internal Failure Cost
External Failure Cost

32
Q

Any validated and controled process will result in fewer internal failures like:

A

Fewer rejects
Reworks
Re-tests
Re-inspection

33
Q

Critical process in pharmaceutical manufacturing to prevent contamination.

A

Aseptic Technique

34
Q

Essential in pharmaceutical manufacturing.

A

Compliance with GMP and FDA.

35
Q

Are critical for aseptic processing.

A

Cleanroom design and maintenance

36
Q

Various sterilization techniques such as ______,______, and _____ are used in pharmaceutical manufacturing.

A

Steam, gamma radiation, and aseptic filtration

37
Q

Require precise control and monitoring to prevent contamination.

A

Aseptic Filling and Capping Processes

38
Q

Are implemented throughout the aseptic processing to ensure product integrity.

A

Quality Control Measures

39
Q

Aseptic Processing presents various challenges including…

A

Personal Training, maintaing sterile conditions, and preventing cross-contamination

40
Q

Include process validation, root cause analysis and continous improvement initiatives.

A

Risk Mitigation Strategies

41
Q

Includes aseptic gowning procedures, aseptic technique training, and ongoing competency assessments.

A

Training and Personnel Qualifications

42
Q

Are transforming aseptic processing.

A

Robotic Automation and close-system processing

43
Q

Essential for optimizing aseptic processing.

A

Continous Improvement Initiatives

44
Q

Paramount for ensuring product integrity in pharmaceutical manufacturing.

A

Aseptic Technique Procedures

45
Q

Essential for staying ahead in the pharmaceutical industry.

A

Anticipating Future Trends and Innovation

Pharmaceutical Manufacturing (1 decks)

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