“The PPPQMS is an element of the pharmaceutical quality system and is required for monitoring, analyzing, controlling, and improving the process performance and product quality. But what defines that system and what tools are available to support it are not always fully understood,” said Guide Co-Lead Line Lundsberg, PhD, Lundsberg Consulting Ltd. “If you are on a digitization journey, this guide is essential, as it will help you by explaining the different PPPQMS elements, offers tools to assess your current maturity level, and defines the aspirational goals for an optimized system that is needed for digital and automated monitoring and control systems.”
“If pharmaceutical companies do not have a system in place for monitoring process performance and product quality according to ICH Q10, they are not in regulatory compliance,” said Christian Wölbeling, Executive Industry Advisor, Körber Pharma Software. “The guide describes Level 3 ‘Managed’ in the APQ 5-Level Maturity Model as meeting the expectations of ICH Q10. This level is recommended as a prerequisite for starting the digitalization journey. Digitalization is the key to advancing the maturity of the Quality Management System from ‘Managed’ to the ‘Improved’ Level 4 and finally to the ‘Optimized’ Level 5.”
The guide provides a quality management framework for assessing and advancing an organization’s PPPQMS maturity level by evaluating the following aspects:
- Establishing a control strategy
- Determining tools for measurement and analysis of parameters and attributes
- Analyzing parameters and attributes
- Identifying sources of variation
- Including feedback on product quality from internal and external sources
- Providing knowledge to enhance process understanding
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Meet the ISPE Staff: Jonathan Kolade
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Jonathan Kolade, IT Operations Manager/IT Department.
Tell us about your role at ISPE: What do you do each day?
The main objective of my role is to keep the ISPE IT infrastructure and services running. This includes implementing and maintaining the security, connectivity, uptime, and functionality of the technology programs, software, and hardware that we use.
What do you love about your job?
Any day of the week can introduce a diverse situation, which usually turns into an opportunity to collaborate with my team members and other colleagues in different departments. There is always an opportunity to develop personally and gain new experiences in the information technology field.
What do you like to do when you are not at work?
Working out, reading, often volunteering in my local community, teaching my kids how to play tennis, and learning to play golf. I also enjoy watching movies with the family.