Over the previous five Blogs in this series we have discussed the critical quality attributes to consider in a robust Quality by Design (QbD) plan for the construction of a new Isolator/RABS fill line. The primary topics we explored are: Regulatory, Surround Areas, Cleaning, Process Interventions and Environmental Monitoring. Here we will talk about when these actions should take place, who should perform them, and what documentation and other activities may be necessary to ensure that you enjoy the quality and contamination control benefits of a well-designed fill line with QbD.
When
Quality by Design (QbD) planning should occur as part of the fill line specification process. QbD testing should be performed during the mock-up inspection.
Who
Who performs the QbD evaluations and makes the recommendations to ensure it is implemented at the equipment design phase may be one individual, a group or a combination of experts working together from different consultation perspectives; including, but not limited to:
- PMS Advisory Services – Including any or all of the following services:
- Advisory Services – to help you achieve the highest level of contamination control and sterility assurance
- Performance Optimization – to design quality into your operations using gold standard PMS tools and processes
- Training – to prepare your employees to ensure success at every step
- An OEM expert/team – for all OEM specific activities
- The Equipment Owner – Including experts from Engineering, Production & Quality
Documentation
The testing and evaluation activities and documentation to support QbD activities may take on many forms depending on the analysis that is required. The Particle Measuring Systems Advisory Team is highly experienced in and prepared to assist you with performing and documenting the following activities and many more:
- Process Risk/GAP Assessment
- Environmental Monitoring Risk/GAP Assessment
- Aseptic Process Simulation (Media Fill)
- Technical Evaluation
- Mockup Inspection
- Training Documentation
- Process Optimization
- Cleaning and Disinfection Evaluation
- Gowning
- Utilities Assessment
- Crisis Management
- Sterility Assurance Audit
Other Activities
There are many other activities that support the hands-on technical evaluations required by QbD. Particle Measuring Systems experts work around the world with physical offices on four continents and representatives in many more local cities and regions. Our approaches comply with FDA, EMA and many other major, regional and local regulatory bodies. Our experts have a vast collective experience with many different manufacturing processes and finished dosages. Additional activities that our experts are available for are:
- On-site Project Management and support
- Remote support
- Review/approval final drawing
In this blog series we have examined what a new fill line looks like with and without QbD implemented at the design phase. We studied each critical area of the fill line and the activities necessary to effectively bring the control features into effect. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.
Learn more about how our Contamination Control Advisory Services Team can help you identify problems and suggest solutions to preserve the high quality of your products and processes.
See links to additional supporting resources below:
- On-Demand Webinar: Developing an Isolator Filling Line Using a Quality Risk Management Approach
- Corresponding Application Note: Developing an Isolator Filling Line Using a QRM Approach – FAQ’s
- Blog: It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)?
- Blog: Applying Quality Risk Management to Develop an Isolator Filling Line
Want to read more? Jump to other released posts in this series:
- Part 1 of 6: Intro and Regulatory
- Part 2 of 6: Surrounding Areas
- Part 3 of 6: Cleaning and Disinfection
- Part 4 of 6: Set up and Process Interventions
- Part 5 of 6: Environmental Monitoring
- Part 6 of 6: Activity Organization(You are here!)
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