Because of the broad expertise in compliance and technical qualifications, eyetec has successfully assisted many pharmaceutical companies with different projects. eyetec has acquired a vast network and built-up intelligence in different fields of pharmaceutical manufacturing. We offer our customers support in compliance, process engineering and Project Engineering for Visual Inspection & CCIT.
During visual inspection audits the whole site, including technical planning and quality are scrutinized and compared to field standards and regulatory expectations. Based on the outcome, eyetec draws-up a bespoke assessment and offers improvement suggestions. Proposed actions can be related to compliance but also technical or logistical.
eyetec analyses the production requirements and facilities together with the client. Based on the necessities, eyetec offers tangible advice and draws up hands-on solutions. From conception to production, eyetec guides customers through the entire process. We can assist with purchasing or designing custom-built VI & CCIT equipment, selecting the appropriate supplier, delivery and testing as well as qualification and validation. eyetec is also able to provide advice during defined stages of the process such as qualification and validation only.
Always up-to-date with the latest regulatory and compendial requirements in the field of Visual Inspection (VI) and CCIT, we offer advice for process improvements and guide customers on how to optimise their compliance status, and how to adopt new regulatory guidance and regulations.
eyetec detects and analyses specific hurdles and problems in the manufacturing process. We conduct investigations and help to define appropriate corrective and preventive action plans (such as in-depth training).
Probability of Detection (PoD) studies play a pivotal role in evaluating inspection methods and determining the detectability of various defect types in pharmaceutical manufacturing. These studies gather crucial data to refine inspection processes and ensure product integrity. At eyetec, we offer comprehensive PoD studies that encompass protocol development, sample handling, inspection execution as needed, result analysis and report generation. Our expert team ensures meticulous attention to detail at every stage of the process, from protocol development to report generation.
