Understanding cGxP: Ensuring Quality in Life Science Industry

cGxP (also known simply as GxP) is an acronym used by the FDA and other regulators within the life science industry. It stands for ‘current good practice’.

cGxP refers to the controlled ‘best practice’ processes and procedures that are being used right now to create products such as pharmaceuticals, and medical devices. GxP guidelines are overseen by organisations such as the American Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

cGxP: What does the X stand for?

The ‘x’ is interchangeable and can be swapped out for other letters to stand for a variety of life science disciplines:

• Current Good Manufacturing Practice (cGMP)
• Current Good Laboratory Practice (cGLP)
• Current Good Clinical Practice (cGCP)
• Current Good Distribution Practice (cGDP)

But why ‘current good practice’?

The use of the word ‘current’ as a prefix for these terms is an acknowledgement that what constitutes ‘best practice’ is always evolving and improving.

As the FDA points out in this blog post about Good Manufacturing Practice:

“The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures.”

FDA compliance requirements allow for companies to use innovative approaches and cutting-edge technology to achieve higher quality through a process of continual improvement.

But the intent and purpose of best practice should always be the same.

The purpose of cGxP

The overall purpose of cGxP is to ensure that life science products are safe, effective and usable for intended consumers.

To demonstrate this is being achieved and to ensure potential non-conformance, output can be identified and corrected - there must be uniformity in design and manufacturing processes, as well as accountability and traceability throughout every stage of a product’s development, manufacture and distribution.

Quality Systems are needed to define and validate cGxP

Regulators, therefore, require Quality Management Systems (QMS) to be in place in order to:

• Define
• Document
• Validate
• Implement

all the key cGxP processes which are used to achieve a consistent standard of quality in end products.

Process validation is key to many GxP guidelines, particularly in the pharmaceutical sector where it is impossible to individually test the quality of millions of tablets rolling off a production line.  

Equipment qualification processes need to be in place to ensure that machinery and software (when maintained and operated correctly) is capable of producing consistent results to required standards.

If it isn’t documented - it didn’t happen

Accountability is essential in the life science production sequence. To this end, GxP ensures that every material action made by every employee during the development, manufacture and delivery of a product is documented and logged.

The risks of non-compliance in cGxP

Why is this important?

Without Implementing best practices via a Quality Management System, organisations will have no auditable means of ensuring consistency in their processes and procedures. Neither will they have a mechanism for isolating and correcting the source of non-conformities in end products when they are identified.

Consequences of the breakdown of best practice in life sciences can, thus, include waste and inefficiencies creeping unnoticed into production processes - right through to the failure of products when they reach the hands of consumers. 

At the more serious end of the scale, it can result in serious physical harm to end users resulting in the revocation of licences, major fines and even imprisonment for those with liability.

Inadequate documentation is a major factor in cGxP non-compliance

Good documentation practice is key to defining and validating cGxP, as well as evidencing that best practice is observed within your organisation. Ultimately, it is the way you prove to auditors and regulators that your business understands and complies with the required quality standards.

It should be noted that many of the fines and sanctions issued around non-compliance in cGxP are as a result of inadequate and incomplete documentation.

Data shows the FDA Observation Form 483 is most commonly issued because there is an absence of written procedures and CAPA processes are not adequately defined or followed. At the same time the MHRA cite insufficient or incomplete validation of systems and processes as a common reason for failed inspections.

What tools do you really need to ensure cGxP?

The digital QMS tools you use to capture, share and iterate best practice through robust documentation is key to how effectively cGxP can be adopted across an organisation.

Those working to design, manufacture and distribute life science products need accessible and flexible tools to help them implement and control the observation of cGxP in a holistic way.

The right QMS should help you:

• Ensure knowledge of cGxP is maintained across your organisation.
• Achieve accountability across an organisation for regulated activity.
• Use cGxP to create high performing products of consistent quality in the most efficient way.
• Minimise risk of product failure - proportional to its potential to harm.
• Provide evidence that regulated products are in conformity with regulatory requirements.

When considering the right quality management systems for your organisation, you should be considering how they can operate as a central repository of best practice to which an entire business can refer for direction and clarification.

But crucially, the right QMS system should also help you control, assemble and track all the documentation you need to prove cGxP have been observed.

This can entail setting up document workflows so that required tasks are always carried out and approved in the right sequence to meet regulatory requirements. It can entail documenting key communication threads in the lifecycle of a product, to be used as proof that GxP have been implemented.

As you perform the tasks of assembling and approving engineering and technical specifications, or verifying and validating software and devices, the right QMS tools can also be storing and indexing all this documentation automatically for future audit.

cGxP is all about control

What constitutes best practice in life sciences is continually changing and evolving with the advent of new technology, so being able to control its orderly adoption and observation across your organisation is vital.

Good document management functioning as an integral part of a QMS is a key part of ensuring (and proving) those evolving practices are always delivering the quality outcomes you expect.

Blog post updated on 28/11/2023