Shutting down parts of a drug production plant for routine cleaning and maintenance work is inevitable and expected. But sometimes downtime is not planned for and the longer the plant is shut down, the more production gets delayed and, ultimately, the longer patients have to wait for their medication.
I spoke with Duncan Cole, Project Manager at Wolters Kluwer Enablon, about his experience with using GMP (Good Manufacturing Practices) permits and how the introduction of these helped to ensure unplanned downtime was kept to a minimum, helping keep production running on time, in his industry days at Novartis, where he spent a 20-year career in product manufacturing and operations.
GMP permits. What are they, and why are they important for ensuring product security and safety?
Duncan: So basically, you’ve got your main permit to work and this basically tells you what task you have to do and has associated risk, isolations certificates, etc. and follows our usual process.
However, when working within a pharmaceutical facility, there is also the need to consider the use of a GMP permit. This is to prove that you’ve done everything that you could possibly do to ensure the area around the place of work is free from contamination before you begin a task.
This is especially the case when preparing for a break-in to the production plant, post final filtration. The GMP permit has a workflow that needs to be checked through with each stage signed off once completed. Such items would be: ensuring the area is clean, there are no visible areas whereby contamination could enter, reconciliation of tools or cleaning materials, and so on.