In this blog I’ll briefly look at how having the right LIMS in place can help to achieve GxP compliance across industries.
Although the term ‘GxP’ covers a wide variety of different sub initialisms (GLP, GCP, GMP, GDP, GVP etc), the general term refers to the regulations applying to quality practices and guidelines associated with the laboratory environment. Adherence to these regulations is ultimately what defines whether the product of your laboratory, be it pharmaceutical, cosmetic, food or clinical is deemed fit for distribution by the relevant governing body. Non-compliance with GxP can result in severe consequences for the associated business.
So it’s clear why being GxP compliant is a fundamental priority for any laboratory whether it be part of a huge multi-national company or a small start-up. Due to the continuous nature of laboratory output, consistency of GxP compliance is also a huge factor, as any gaps in compliance can potentially lead to huge recalls and financial implications for the company.
In accordance with 10 principles of GxP, as illustrated by ‘Bizfluent’, I will be briefly elaborating on how a LIMS can support each principle, and ultimately provide harmony in the laboratory.
1. Written Procedures
Developing a step-by-step ‘roadmap’ of procedures (or SOPs) is integral to providing consistent processes and adhering to GxP practices. Having a LIMS in place in your laboratory can provide an easy solution to this; once SOPs have been initially established, they are stored within the system and are available for users to access easily.
2. Following Procedures
Having written SOPs in place for your laboratory processes is only effective if they are consistently followed by all users. Deviation from the defined processes can be detrimental for the business, as it can adversely affect the consistency of quality.
A LIMS can support this principle by presenting relevant SOPs and visual workflows to the user performing the task. In several systems there is also the potential to restrict access rights for certain tasks to adequately trained users, eliminating the risk of untrained personnel carrying out crucial tasks.
Accurate documentation is understandably a huge focus in any laboratory environment, allowing any issues or concerns to be traced effectively and providing evidence that all laboratory staff have followed due process in compliance to the SOPs. A LIMS excels in this area as data entry is documented instantaneously at the time of entry and an electronic signature is recorded to detail both the user and piece of equipment which was used. This provides an easy and accessible audit trail should one be required.
4 . Validating Work
Validation of systems and workflows is highly important to GxP compliance as it ensures that all systems and procedures are working correctly. Having a LIMS in place in a laboratory provides the functionality in order to validate aspects such as instrument calibration and QA/QC information.
5. Facilities & Equipment
Although the facilities and equipment in a laboratory are largely in place before a LIMS, the function that a LIMS can provide in this instance is maintaining and ensuring the suitability of the equipment for the task at hand.
Through the analysis of results documented in the LIMS, trends that could potentially point to unsuitability in equipment can be identified and addressed.
This principle is undoubtedly more suitable to the functionalities of a LIMS. Consistent report generation and calibration can identify maintenance issues in equipment and the system can then flag with users which equipment is unavailable and subsequent avoid it being used.
If a GxP audit took place and the audit trail flagged equipment requiring maintenance being used as part of the process, it would fail the audit.
7. Job Competence
Also hugely important in the matter of GxP, this ensures each user responsible for a task is adequately trained and qualified. A LIMS can support this by storing the training records of staff and being calibrated to prevent users carrying out actions for which they are not authorised.
8. Avoiding Contamination
A major concern in any laboratory environment is the potential risk of product contamination. Having the right LIMS and processes in place minimises this risk as much as possible by monitoring specific locations and processes for contamination risks and flagging them for the appropriate steps to be taken.
9. Quality Control
As a fundamental aspect of laboratory production, quality control is hugely important to ensure that each aspect of the product is supported by diligent records and quality assured processes. The electronic logging of all activity in a LIMS is integral to supporting this principle as it allows effective tracking of the entire cycle of the product, thereby assuring quality.
Regular auditing is the most quantifiable way to ensure that GxP regulations are consistently being met. A LIMS particularly excels in this area as it provides the auditor access to all required information from a single source, including training records, instrument maintenance records and QA/QC documentation.
In conclusion, having the right LIMS in place for your laboratory can contribute hugely to ensuring that you are fully compliant with all aspects of GxP, an essential requirement for any laboratory.
Thank you for taking the time to read this LIMS blog and if you are interested in discussing some of the points raised please do not hesitate to reach out to me!