Operational Audit in Production Facility

The purpose of the audit

The main purpose of an audit in a production facility is to ensure that all standards and procedures are properly implemented and followed.

Pharmaceutical production facilities must pass statutory audits across regulatory compliance, facility engineering, supply chain integrity, and environmental health and safety (EHS). Auditors travel the world and need simultaneous interpretation to communicate with local staff. Interpreters must be fully mobile so they can move with the group between different buildings, clean zones and production areas.

In this case we first ran a test audit and then the actual Regulatory GMP Inspection six months later in line wit EU Directive 2001/83/EC, EudraLex Vol. 4 (National Authorities e.g., GIF, EMA, FDA). These are external inspections required every 2–3 years to maintain the mandatory Manufacturing and Importation Authorization (MIA) and GMP Certificate.

Operational Audit in a Production Facility

We designed a complete hybrid technical and interpreting setup that combined local presence with a prduction facility with a remote regional department responsible for overseeing the process. The areas covered included

Production halls
Production processes
Procedures
Compliance with standards
Rules and legal regulations

over a period of 10 days in total.

What we delivered

We regularly support pharmaceutical manufacturers with both official audits and practice (pre-audit) trials.

In a typical practice audit, one lead auditor works on site, giving instructions and examining processes, while specialists from the same organisation based in different countries join online. They need to see and hear everything in real time. This requires us to deliver both high-quality simultaneous interpretation and reliable audio + video feeds from the production floor to the remote participants.

One of our clients also uses Microsoft HoloLens during these audits. The auditor or local engineer can show specific equipment, processes or documentation in augmented reality. We integrate the HoloLens video stream into the overall feed so that both on-site and remote participants can follow what is being demonstrated while listening to the live translation.

Real use case – Pharmaceutical sector

For the most recent full-scale audit we used a hybrid approach:

On site we set up a professional interpreting booth so that local participants could listen to the live simultaneous translation through receivers and headsets.
At the same time we fed the interpretation channels directly into Microsoft Teams over the client's secure network, allowing remote participants in other countries to select their preferred language and listen to the same high-quality simultaneous interpretation.

One language combinations were covered English <==> Polish. This guaranteed maximum accuracy on sensitive pharmaceutical topics.The audit ran for a full working week. Participants changed frequently according to the topic under review.

After every change of particiapants from different departmenets of the organization that were participating in the audit, we supplied freshly disinfected receivers and headsets. In total we prepared 500 sets for approximately 100 interviews.

How we delivered the interpretation

Accurate, real-time communication between auditors, local staff and remote experts
Full visibility of the production floor (including HoloLens streams) for online participants
Higher efficiency and shorter overall duration compared with consecutive interpreting
Reduced risk of misunderstandings on critical compliance topics

If you are preparing for a pharmaceutical audit, practice audit or any multi-location production-floor inspection and need simultaneous interpretation both on site and online, contact us. We will design a solution that keeps everyone connected and compliant.