Pharmaceutical and life science industries must adhere to the same stringent manufacturing standards as the rest of the industry. The industry standards are part of GxP guidelines, the holy bible of the industry.
GxP in a nutshell
GxP stands for the various "good practice" regulations and guidelines that apply to the industry's manufacturing organizations. Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Storage Practices (GSP), and other processes used in the development, manufacturing, and distribution of regulated 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 in place and a clear picture of what needs to be done, pharmaceutical manufacturers face some challenges during the production management process. One of the keys to overcoming these challenges is, of course, process digitization. However, in these regulated industries that require a high level of compliance, digitization of the process is insufficient. 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, bringing a bunch of benefits, bringing better operational management and guaranteeing full control over the production process. Of course, an appropriate IT solution is required to assist you in streamlining all internal processes, making them more efficient, and ensuring compliance.
Here are four bullet points to consider if you want to implement an IT solution in that area:
- Choose the Right Solution to Have Full Flexibility
Automatisation of GMP processes starts with choosing the right solution. When searching for a technology product, you have to ensure that it is flexible enough to modify according to your existing process. Each pharma company has its specifics, and buying and relying on an off-the-shelf solution with no option to tailor to your use cases 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, the industry changes and sooner or later you will need to adapt the software to fit the circumstances.
The right strategic approach is to identify a trusted IT partner with industry 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 in The Solution
Integration of the processes is crucial in almost all the industries worldwide 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, corrective actions, compliance handling and audit trails.
The whole documentation, training and audit management will be under your control at any time, centralised in one place and ensuring complete data integrity.
- Reduce The Risks by Defining Them
Every automatisation 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 standardise this process. Incorporating risk management 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 centralised reporting that is one of the biggest advantages of these kind of solutions.
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 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 optimise the production.
Automating your GMP compliance processes is a critical convenience for your company that will result in long-term measurable results.
BGO Software has unbeatable experience in designing and deploying intelligent IT solutions for leading pharmaceutical manufacturers. We act as a trusted advisor, partner and IT consultant for our customers to deliver maximum value and reduce the risks. Reach out to find out more.