Finals Flashcards
Systemic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding.
Quality by Design (QbD)
Crucial in pharmaceutical manufacturing .
Regulatory Landscape
Fundamental in Qbd. Identifying and mitigating potential risk in manufacturing process is key to maintaining product quality and safety.
Risk Assessment
Involves the establishment of ranges process.
Design Space
Essential for managing variability and ensuring product quality.
Control Strategy
Enables real-time monitoring and control of manufactiring processes.
Process Analytical Technology (PAT)
Vital in pharmaceutical manufacturing. By continously evaluating and optimizing processes, manufacturers can achieve enhanced efficiency and product quality.
Continous Improvement
Paramount in optimizing pharmaceutical manufacturing.
Leveraging advanced technology
Integral to optimizing pharmaceutical manufacturing.
Supply Chain
Pivotal in pharmaceutical manufacturing.
Resource optimization
The embraced of QbD principles has a profound
Global Impact
The future of pharmaceutical manufacturing is shaped by the continous evolution of QbD principles.
Future Perspectives
Pivotal in optimizing pharmaceutical manufacturing
Quality by Design
Crucial for successful validation.
Regulatory Requirements
Key step in the validation process. It should include detailed plans for
Qualification, Process Performance Qualification (PPQ) and Continued Process Verification
Essential to identify and mitigate potential risk in the manufacturing process.
Risk Assessment
Throughout the validation process is critical.
Data Integrity
Essential to maintain the accuracy and reliability of data.
Data management system and ISO guidelines principle
Stage involves demonstrating that the manufacturing process consistently producess product meeting predetermined specifications.
Process Performance Qualification (PPQ)
Essential provide evidence of compliance with regulatory requirements.
Validation Documentation
Ensuring that personnel are adequately trained and qualified to perform validation actvities is crucial.
Training and Qualifications
Essential in maintaing validated process.
Continous Improvement
Intiatives contribute to ongoing compliance and quality enhancement.
Quality Reviews and Process Optimization
Crucial in demontrating compliance with regulatory requirements.
Audits and Inspections
“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.
Process Validation (defined by FDA)
During this staged based on knowledge gained through development and scale up activities.
Stage 1 - Process Design (PD)
During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
Stage 2 - Process Qualification (PQ)
Ongoing Assurance is gained during routine production that the process remains in a state of control.
Stage 3 - Continous Process Verification (CVP)
Validation is an extension of the concepts of quality assurance since close control of the process is necessary.
Assurance Quality
The optimization of a process for maximum efficiency, while maintaing quality standards, is a consequence of validation.
Process Optimization
Quality cost are divided in to four categories.
Preventive Cost
Appraisal Cost
Internal Failure Cost
External Failure Cost
Any validated and controled process will result in fewer internal failures like:
Fewer rejects
Reworks
Re-tests
Re-inspection
Critical process in pharmaceutical manufacturing to prevent contamination.
Aseptic Technique
Essential in pharmaceutical manufacturing.
Compliance with GMP and FDA.
Are critical for aseptic processing.
Cleanroom design and maintenance
Various sterilization techniques such as ______,______, and _____ are used in pharmaceutical manufacturing.
Steam, gamma radiation, and aseptic filtration
Require precise control and monitoring to prevent contamination.
Aseptic Filling and Capping Processes
Are implemented throughout the aseptic processing to ensure product integrity.
Quality Control Measures
Aseptic Processing presents various challenges including…
Personal Training, maintaing sterile conditions, and preventing cross-contamination
Include process validation, root cause analysis and continous improvement initiatives.
Risk Mitigation Strategies
Includes aseptic gowning procedures, aseptic technique training, and ongoing competency assessments.
Training and Personnel Qualifications
Are transforming aseptic processing.
Robotic Automation and close-system processing
Essential for optimizing aseptic processing.
Continous Improvement Initiatives
Paramount for ensuring product integrity in pharmaceutical manufacturing.
Aseptic Technique Procedures
Essential for staying ahead in the pharmaceutical industry.
Anticipating Future Trends and Innovation
