Within the life science and pharmaceutical industry, adherence to stringent manufacturing standards is non-negotiable. Governed by the GxP guidelines, often considered the holy bible of industry standards, these regulations ensure the utmost quality, safety, and efficacy of products. However, the complexity and volume of regulatory requirements within Good Manufacturing Practice (GMP) can be overwhelming. In response to this challenge, the industry is turning to a transformative solution — the automation of GMP compliance management processes. This shift not only addresses regulatory intricacies but also marks a significant evolution in the pursuit of excellence within pharmaceutical manufacturing.
GxP in a nutshell
GxP stands for the various “good practice” regulations and guidelines that apply to the industry’s manufacturing organizations. Good Automated Manufacturing Practices (GAMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Storage Practices (GSP), Current Good Manufacturing Practices (cGMP), and other processes used in the development, manufacturing, and distribution of regulated manufactured products are covered by the “x” variable in GxP.
The following regulations outline GxP requirements:
- In the United States, Title 21 CFR Part 11 is enforced by the Food and Drug Administration (FDA).
- Volume 4 of EudraLex – GMP Guidelines, Annex 11 in the European Union.
Despite all of the regulations and different systems in place and a clear picture of what needs to be done, pharmaceutical manufacturers face some challenges during the production management process. An essential part of overcoming these challenges and continually improving operations is, of course, using digital tools for process digitization. However, in these regulated industries that require a high level of compliance, more than digitization of the process is required. Process validation and automation are also required.
Automatisation of the GMP Compliance Management Processes is an investment that will reflect on your company’s results in the long term. This will ensure continuous improvement of standard operating procedures, better operational management, and a guarantee of full control over the production process and product quality. Therefore it’s a great way to improve customer satisfaction as well. Of course, an appropriate IT solution – a quality management system – is required to assist you in streamlining the entire process, making it more efficient, and able to maintain compliance with relevant regulations.
Here are a couple of points to consider if you want to implement a quality assurance system in that area:
Choose the right solution to have full flexibility
Automatization of GMP processes starts with choosing the right compliant GxP computerized systems. When searching for a technology product, you have to ensure that it is flexible enough to modify according to your existing processes and quality standards. Regulated companies have their specifics, and buying and relying on off-the-shelf computer system validation with no option to tailor it to your use cases beyond its defined procedures can be a dangerous move. Don’t expect to find a solution that will be suitable for your processes forever without any changes. Your business changes, GMP standards change, the industry changes and sooner or later you will need to adapt the software to fit the current manufacturing procedures.
The right strategic approach is to identify a trusted IT partner with industry technology expertise who has the needed experience and ready platforms, which can be easily modified to fit your needs. In this way, you eliminate the risk while decreasing the market time.
Integrate your processes into the solution
Integration of processes is crucial in the international society of industries nowadays. The best solution for automating your GMP management processes will allow you to integrate all existing processes in a commonplace. Implement a single solution for document control, audit management, compliance training management, corrective actions, compliance handling, and audit trails.
The whole documentation, training, and audit management will be under your control at any time, centralized in one place and ensuring complete data integrity.
Reduce the risks by defining them
Every automatization is good, but in many aspects, companies rely on humans to make the final decisions. By now, technologies have not reached the level where they could automate decision-making, but it is possible to standardize process development. Incorporating risk assessment into your business is maybe the best practice for doing it.
This will make it possible to create a risk template for all applications that will allow you to assess high-risk gaps, run a risk-based verification check, and even benchmark suppliers according to risk level.
Don’t forget reporting
Once you find the right solution for automating your GMP management processes, you will need to observe everything happening in your business. Here comes the centralized reporting which is one of the biggest advantages of this kind of solution.
You can make reporting more effective by focusing on some basic steps:
- Report template. Create an appropriate template for the needs of your reports and access them with a single click.
- Auto-generation. If you need some information to be shown weekly, you can set up some reports that will automatically be sent to your team аs you scheduled.
- Dashboard metrics. The best solution for your needs will let you choose the most important metrics that you want to see on a single dashboard at any time. This will allow you to always keep an eye on your priority metrics.
- Exception reporting. Your business – your rules. With exception reporting, you can get notifications when certain conditions or events occur. You can use these reports to optimize manufacturing products.
Automating your GMP compliance processes is a critical convenience for your company that will result in long-term measurable results.
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When dealing with pharmaceutical products like medical devices and prescription drugs, it is in the job descriptions of regulatory bodies to ensure that such products are consistently produced with no serious violations. It is in BGO Software’s job description to assist in designing and deploying intelligent IT solutions for leading pharmaceutical manufacturing companies. We act as a trusted advisor, partner, and IT consultant for our customers to deliver maximum value and reduce risks. Reach out to find out more.