Insights from the PDA - By Bram Keymolen

How to Boost Your MVI: A Case Study to improve Efficiency (Antonio Burazer, Takeda) 

Antonio Burazer presented a Takeda project spanning 2020 to 2025, aimed at enhancing MVI efficiency while maintaining the highest standards for safety, compliance, and supply chain reliability. These improved practices were implemented not only at Takeda’s global sites but also at their contract development and manufacturing organizations (CDMOs), each with their own established practices and cultures. 

A central factor for success was harmonizing the classification and naming of defects. Additionally, Antonio emphasized the importance of thoroughly documenting inspection methods-including photos, timing, and points of attention-to achieve a standardized approach. As he aptly put it, “dissect the method into all the separate elements.” 

Another key takeaway was that, despite advances in automated visual inspection, manual visual inspection remains essential in pharmaceutical manufacturing. This is particularly true for small batch sizes or when a wide variety of products and containers require inspection. 

I also noted the innovative use of AI tools to assess the ergonomic impact of MVI tasks. This approach helps optimize workflows, reduce operator fatigue, and improve performance over time. 

From Sight to Insight: Revolutionizing Pharmaceutical Manufacturing with Visual Inspection Systems (Bill Waterstreet, Performance Validation) 

Bill Waterstreet advocated for the ASTM2500 approach, in which all testing is performed only once, moving away from traditional post-commissioning qualification. According to Bill, this methodology delivered significant benefits to their project. 

He stressed the importance of process expertise in both visual inspection and sterile filling for successful automated visual inspection (AVI) implementation. Bill also recommended conducting an impact analysis for each vision parameter, enabling release by exception when minor configuration changes are needed for specific batches. 

His presentation highlighted the importance of data integrity in AVI and the value of risk-based approaches. A final key takeaway was his advice on ensuring the long-term reliability of AVI systems, such as establishing robust cleaning procedures during engineering runs and maintaining consistency in light source specifications, since changes in color temperature can affect detection efficiency. 

Manual VI Inspector Training and Qualification (Tracey Sinjen, Lachman Consultants) 

Drawing from extensive regulatory inspection experience, Tracey Sinjen emphasized that a solid product risk assessment forms the foundation of an effective visual inspection process. This assessment should be comprehensive and directly linked to operator qualification and acceptable quality limits (AQL). 

She clarified terminology: a defect catalog is a document containing pictures and descriptions of each defect type, while a defect library is a physical collection of defects used for training and qualification. 

Regarding visual inspection test kits, Tracey advised that positive controls should contain only a single defect and recommended keeping a spare set available. She also stressed that defect trends identified in production should feed back into the product risk assessment, which should be reviewed annually to incorporate new data. 

When training operators, it is crucial to explain the importance of visual inspection and the removal of specific defects from each lot. For operator qualification, Tracey suggested three consecutive passes for initial qualification and a single pass for re-qualification. 

Finally, she highlighted several notable FDA 483 observations. The ones that caught my attention were; the use of deteriorated test kits, insufficient quality oversight of operator training programs, and instances where the same operators performed both AQL and 100% MVI.