More efficient compliance with GMP guidelines

When complying with Good Manufacturing Practises (GMP), it is essential to accurately record how and under what conditions a product is made. Therefore, the importance of quality management is crucial. But how do you make sure this is done properly and efficiently?

Human and veterinary drugs, food, and cosmetics: before such products reach the stores, an entire process precedes them. After all, their production is not entirely without risk.

Suppose a mistake is made in a drug’s composition, which is discovered too late. Not only can this have disastrous consequences for the consumer, but it is also a disaster for the pharmaceutical industry.

Good Manufacturing Practices aim to prevent this from happening. This means that everything (but really everything) before, during and after the manufacturing process must be recorded in detail. In this article, you will read how to comply with GMP guidelines as efficiently as possible.

Tracking errors

Mistakes and errors are easily made. Think of mix-ups due to incorrect labelling, an operator who signed but did not write down the date, and cross-contamination between drugs. If it turns out afterwards that something has gone wrong, it is crucial to trace how a product was made, who tested it and what raw materials were used.

If all procedures were recorded manually in Excel and Word, the question is whether this can be traced.

• For example, who keeps track of current versions of documents?
• Who ensures that actions are followed up?
• How do you know whether an employee has actually read and understood the new work instruction?

Not to mention the error-prone nature of manually maintaining procedures.

In detail

In addition, the procedures must also run a certain way to qualify for GMP certification. Regular inspections must be carried out, the manufacturing processes must be written down on paper, and it must be recorded whether all steps in the process have been carried out correctly. If these steps were not performed properly, what exactly the bottlenecks were must be described.

Start automating

You can save quite a bit of time if you start automating the above processes to the extent possible. Just think of the advantages that a document management system or a reporting system can offer. You always have all (up-to-date) information to hand, documents automatically go to the right people, responsible persons are notified when follow-up action is required, and you always have insight into complaints, incidents, etc., from anywhere. Moreover, during an audit, you can demonstrate why a document or procedure has been changed and how you keep an overview.

With one press of a button

However, automation offers even more advantages. By recording all steps in a process, you build a data database. This provides a wealth of information with which you can create clear reports at the push of a button.

For example, think of an overview of all reports: which reports were made during a certain period, who was responsible and what is the status?

In addition, software also makes it possible to register Capas (improvement actions) and thus optimize the process. For example, control questions can be used to determine whether an employee has also understood the instruction.

Not only can efficiency gains be made in quality requirements operational processes, but the risk of (repeat) errors and data loss is also minimized. After all, everything is recorded online.

Faster via an app

Incident management software can also lower the threshold for employees to make a report if they can do so via an app on their smartphone. If they spot a particular situation or anomaly, they can report it on the spot and easily. Through the app, they answer some standard questions and, if desired, can easily add a photo.

This saves time since they do not have to go to a PC and look up the report form, but also more reports and reports that are more complete.

Optimal return from automation: five tips

It is clear that automated processes lead to efficiency gains. However, this is not simply a matter of implementing a software package and getting started. To meet GMP more efficiently, you need to think carefully before implementing what you want to achieve.

1. Make sure it is evident in advance what standard requirements the entire production process must meet. In other words, what must you be able to demonstrate during an inspection and audit?
2. If many different processes must be documented, it may be interesting to choose an integral solution. This allows you to record all aspects of quality management in one system. For example, think of: audits, inspections, risks, CAPA, deviations, et cetera.
3. Get references from companies in your industry. Not every package offers the specific requirements that apply to your industry. References help in choosing a proven package.
4. Think carefully about input and output in advance. How are you doing now, what do you want to improve, and what do you want to achieve?
5. Choose software that supports validation processes. If there is an update of a procedure, the software should always allow you to measure whether the update is reliable before the changes are actually implemented.