Quality & Compliance
Automated Visual Inspection (AVI).
Identify defects before they become a problem. We support pharmaceutical companies in the implementation and validation of AVI systems for quality control—in full compliance with EU GMP Annex 1.
How do pharmaceutical companies improve quality control through automated visual inspection?
Manual visual inspection in pharmaceutical manufacturing is labor-intensive and extremely prone to errors. Manufacturers face significant challenges:
- Manual inspection is subjective: Variations among inspectors and fatigue effects significantly skew the results.
- Regulatory requirements for method validation (EU GMP Annex 1) are constantly increasing.
- It is no longer economically feasible to perform 100% visual inspections of high-volume production runs manually.
- False rejects caused by imprecise systems cost pharmaceutical companies a lot of money every day.
- Manual inspection ties up significant staff resources: In typical fill-finish lines, 80–100 full-time equivalents (FTEs) are dedicated solely to visual inspection tasks—with the associated labor costs, shift premiums, and risk of employee turnover.
Have you verifiably validated your inspection methods, and do your detection rates (PoD) meet regulatory requirements?
Our AVI services.
We guide you through the entire AVI implementation process—with a solid technical foundation and full regulatory compliance.
AVI System Selection & Setup
Analysis of product types, defect profiles, and throughput targets. Technology comparison, supplier selection, and definition of robust defect libraries (training sets for AI).
Method Validation & Knoll Studies
Statistical determination of the limit of detection (PoD) through Knoll studies. Regulatory demonstration of the equivalence or superiority of AVI compared to manual inspection.
GMP Validation (IQ/OQ/PQ)
Full validation of the AVI system as a computer-based system in accordance with GAMP5. Secure integration into the QMS for change control and out-of-specification (OOS) handling.
Performance Monitoring Program
Establishment of a system for ongoing monitoring: Monitor false rejection rates, detection rates, and system uptime to ensure long-term GMP compliance.
What we have achieved.
Anonymous Project · Pharmaceutical Manufacturing · Fill-Finish. Complete value chain from business case to production handover.
89 → 2
Inspectors replaced by two machines — the remaining specialists will focus on validation and continuous improvement
€4.2 million
Annual savings (direct labor costs) after full implementation
< 2 Jahre
Return on Investment – including machinery investment and project costs
42 → 7 days
Recipe iteration time – thanks to our image capture method prior to go-live
Why our implementations launch faster.
The critical bottleneck in every AVI project is the prescription iteration. The industry average is 42 days per prescription—we achieve 7 days.
Standard approach
Approx. 42 days per prescription
- Capture images & create a recipe
- Go into production
- Find out which batches are being canceled
- Iteration – slow and costly
Entourage Approach
7 days per prescription
- Capture image data across multiple batches and the full range of product variations—before the go-live
- Proprietary software processes over 4 million images
- A robust solution from day one – no reactive iteration
Our team’s expertise in machine recipe development is systematized and tool-based—not dependent on individual team members. That is why we are the industry benchmark.
Frequently Asked Questions About Automated Visual Inspection (AVI).
What regulatory requirements apply to AVI?
EU GMP Annex 1 (2023) explicitly addresses AVI for parenteral products. The requirements include: validation, determination of detection limits, comparison with manual inspection, and ongoing performance monitoring.
What is a Knoll study?
A Knoll study is a statistically planned test designed to determine the probability of detection (PoD). In this process, samples with defined defects are tested to demonstrate the reliability of the inspection system.
Can AVI completely replace manual 100% inspection?
Yes—provided that the AVI method has been validated and has been demonstrated to be at least as good (or better) than manual inspection. The EMA and FDA accept this provided the validation is sound.
What is the difference between AVI and In-Process Control (IPC)?
AVI is typically a 100% inspection of the finished product (end-of-line). IPCs are random inspections conducted during the manufacturing process (e.g., fill weight). The two are complementary and do not replace one another.
Additional expertise in the area of Quality & Compliance.
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