Equipment qualification for the introduction of a new production line: Tips and tricks

What is equipment qualification?

Equipment qualification is a series of inspections, tests, and assessments to ensure that a given piece of equipment is compliant and ensures reliable performance. It is required to prove that a given piece of equipment does, on a consistent basis, what it is supposed to do. In the pharmaceutical industry, equipment qualification is critical because the slightest error or misuse can pose a costly risk and time delay for the pharmaceutical product owner and their manufacturer.

Planning

Good planning is one of the most important building blocks to make a validation project successful. This sounds very logical, but in reality it is not obvious.

To speak of good planning, several factors need to be taken into account. A first factor is a feasible schedule for all teams involved. Each team, for its own tasks, will draw up its own schedule. All the schedules of all the teams should be laid alongside each other to create one overall schedule. A deadline may be feasible for a particular team but the same deadline may not be feasible in the overall planning. Is no overall planning set up? Then, sooner or later, deadlines will overlap and cannot be met.

Taking into account possible project delays, is a second important factor to consider. Experience has shown that no project runs flawlessly and perfectly. So allow enough margin for deadlines to avoid missing deadlines time after time. Even if possible project delays are already taken into account, challenges will still arise during an equipment qualification project that will prevent certain deadlines from being met. At such times, adjusting the planning is unavoidable. Postponing deadlines is strongly advised against. Although it may seem like the easiest solution, especially at the beginning of a project when the date for final delivery of the new production line is still far in the future. Postponing deadlines usually has an impact on subsequent deadlines. A better way to deal with such a situation is to see if certain tasks can be swapped. For this, teamwork and good communication between the different teams is very important.

Teamwork and communication

A project stands or falls with good teamwork and communication. The team of which you yourself are part, needs to communicate well about who will take care of which system or task. A daily follow-up meeting is an efficient way to follow up on statuses of systems or tasks, distribute new systems or tasks, and discuss issues that are struggling.

Furthermore, there is a need for teamwork and communication between the different teams. Qualification of equipment always involves several parties e.g. a validation team, a calibration team, IT, a system owner, QA, a sampling, team engineering… It is not the case that the same teams are involved for every system. So it is important to check which teams are involved for each system. Then, when there is a problem with that system, a meeting can be set up with just the teams involved.

During a weekly follow-up meeting with all teams, the status of the systems can be monitored, delays can be discussed and the impact of those delays on the other teams can be determined. To make a follow-up meeting, with all teams, run efficiently, it is a good idea to appoint someone within each team to monitor the weekly follow-up meeting. This way, you keep the number of people in the meeting to a minimum.

Moreover, a person or team should be appointed to be the general point of contact for everything related to the project. This team is also responsible for following up the planning and adjusting it in time. The weekly follow-up meeting is usually led by someone from this team.

Design Qualification

The introduction of a new production line, involves the purchase of many different systems. A potential pitfall is that certain brands or types of systems are purchased because they already exist on site and work well. But for each production line, systems have different specifications they have to meet. It is therefore very important to check whether all systems meet the predefined specifications to be suitable for the intended purpose, meeting regulatory and process needs.

Conclusie

With feasible planning, good teamwork, clear communication and comprehensive design qualification, an equipment qualification project can be carried out successfully. Do pitfalls or challenges come up during the project? Don’t see it as a setback but as a learning opportunity for future projects.