Proof that solutions for injections are free from visible particles
GAMP 5 life cycle approach
To ensure the safety, quality, and integrity of our visual inspection machines, we follow the ISPE GAMP 5 methodology in our development process. This involves a lifecycle approach, where we address these critical aspects from conception to decommissioning. By following GAMP 5, we prioritise patient safety by minimising risks associated with product defects. We also maintain product quality by adhering to rigorous validation processes throughout the machine’s lifecycle. Moreover, we ensure data integrity, crucial for accurate inspections, by implementing robust control measures. This reflects our dedication to delivering reliable inspection solutions for GMP companies.
Data Integrity: scan to storage
With the data gathered from the visual inspection cycles, you can gain valuable insights in the defects and their root causes. Our VI-Detect software generates batch reports to give in-depth overviews of your production process. Maintaining data integrity and safe data storage is important, so besides being CFR Part 11 compliant, we integrate the data storage and backup to the infrastructure you require, or we can support you in setting-up stand-alone solutions for this.
Fully compliant validation
Just as the manual visual inspection process, automated visual inspection machines are validated against proven test-sets using the Knapp-Kushner method. These challenge-sets contain every type of defect imaginable, adjusted to the products you are making. The goal of these challenge-sets is to quantify the visible contaminations, according to the US Pharmacopoeia and EU. Pharmacopoeia.
While test-sets can be made by the GMP regulated company itself, Luo has an extensive partner network with experienced Subject Matter Experts (SME’s) that can provide challenge sets, support in validation strategies and the execution of validation steps.
It goes without saying that Luo can provide templates and advice for all necessary validation steps.
Luo Automation
Julianalaan 67, 2628 BC, Delft,
The Netherlands
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