Looking to become GMP compliant can be a daunting task, however the benefits of it to your order book can be significant.
In this article we will discuss the what it means to be GMP compliant, the benchmark tests for GMP compliance and finally, we will discuss how Receta can take care of several sections of your compliance requirements, leaving you free to handle the ‘physical’ organisation part of the GMP framework guidelines.
What are the guidelines I should work towards to become GMP compliant?
In advance of attempting to gain your GMP certification you should make yourself aware of the requirements you will need to adhere to. A great resource for this can be found at:
Another good source of information can be found at:
http://www.ehpm.org/attachments/article/117/EHPM%20Quality%20Guide%20101214.pdf
And specific to the UK, the governing body – the MHRA, offers the following guidance, which although centred around medical and pharmaceutical products gives an excellent outline of the requirements you will have to comply with:
https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice
What does becoming GMP compliant actually mean?
In essence, as the title suggests, becoming GMP compliant means your business is operating within a common framework given the title of GMP or “Good Manufacturing Practice”. Obviously, within each business sector, there are niche requirements dependent upon the processes you go through during manufacturing, the usage of materials and staff interactions; however, the general principals are similar for any business.
What is the purpose of the GMP Guidelines?
By moving your business into GMP compliance (and then using that as a potential marketing tool), you can both improve your business offering, make the quality of your finished product improve consistently, streamline and standardise your internal management processes, ensure the health and safety of your staff AND attract a potential sales audience who are specifically looking for their supplier to be GMP compliant.
The underlying goal behind GMP is to standardise several areas of the manufacturing process, thus ensuring customer satisfaction (and in some cases safety) when buying your products. It also ensures you are running the manufacturing parts of your business safely, efficiently and most of all making sure your business can withstand any third party audit, product recall or inspection at any time.
What are the first practical steps I should look for when starting out with GMP compliance?
As referenced above, by following the general guidelines for GMP compliance, you can effectively create a large tick box document for all of the tasks you believe you need to complete in order to pass the GMP tests. Group the tasks into the sectors of your business and appoint a sector ‘champion’ who will be responsible for making sure the tick boxes can be ticked for their sector. Set deadlines for the completion of the tasks and have regular meetings with your champions to check progress.
What are the pitfalls for becoming GMP compliant?
One the most common issues with GMP compliance is that in some cases, the changes needed to your working practices are quite significant. Although from a management or board level perspective, these changes may seem obvious and something which “simply has to be done”, at ground level that may be much easier said than done. In many cases, the existing working practices are engrained in staff and you may find that you have to overcome some deeply held personal preferences and beliefs in order to get the new required ways of working into practice.
To this end, I would recommend that before you attempt to make any changes, you first conduct several scoping meetings with your staff. Explain the plans you have and listen to their concerns and ideas for how best to proceed.
In many cases the ‘end-game’ plan for how you need to work as a business may not be achievable straight-away, in which case you may need to move your working practices incrementally over several months to a point where you meet your original requirements.
Failure to do this can have two major effects.
1) By moving too quickly, you can alienate your staff and you may find that your big changes never take hold, or
2) If you take too long to make the changes OR the changes are not monitored, you may find that your staff quickly slip back into their previous practices, making your job even harder!
When I’m ready how I become certified as GMP compliant?
Each country or region of the world has its own governing body which deals with GMP certification, an indeed you can employ the services of any number of third party consultants who can help smooth the process of becoming certified.
You may also wish to approach your governing body directly for an assessment. Be aware that either option usually carries a fee therefore it’s wise to do as much work in advance to be sure you are compliant before going for an assessment.
How can Receta help with your GMP compliance?
Many of the GMP guidelines are related to physical interactions with staff, machinery and materials within the business, however there are several areas relating to good working practices and record keeping where Receta can really help.
Many of the guidelines like to encourage you to maintain accurate records of your adherence to the GMP compliance requirements on an on-going basis. This could be:
- The on-going compliance with the operating instructions of a machine.
- Maintaining accurate records of your handling of materials both in and out of the business
- Your ability to handle quarantined materials
- Your ability to maintain accurate production records and master batch production instruction compliance
Plus many other areas of record keeping. In all of these cases, Receta includes functionality to ensure you are able to pass these tests easily and quickly. Best of all, as your staff use Receta in their daily working tasks, they will naturally be building up the data required as a part of your GMP compliance requirements. This means that should you ever have your GMP compliance audited, you can showcase your Receta system and all of its features for compliance, without your staff needing to complete any further paperwork specifically for the GMP side of things.
The features such the quality document store, the production method management, material attribute management and much more all help to ensure your journey to become GMP compliant is as straight-forward as possible!
How can we here at Receta help to ease you into your new software?
By choosing Receta as your preferred ERP for your business, you can be sure that we will become a useful addition to your skill-set within your business. As part of your adoption of Receta, we offer on-site training to help aid adoption of the software as well as free video conferences, help videos and more.