GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their regulation of the life sciences industry. GMP stands for Good Manufacturing Practice, while cGMP stands for Current Good Manufacturing Practice.
The intent of GMP is to ensure the manufacture of pharmaceutical products, medical devices and other regulated items are carried out in a controlled way to achieve consistent levels of safety and quality in end products.
What does the C stand for?
The addition of the prefix ‘current’ recognises that what constitutes ‘best practice’ is continually improving and evolving with the advent of new technology. As the FDA themselves state:
“the "C" in cGMP stands for "current," requiring companies to use technologies and systems that are up-to-date to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.”
Because life science manufacturing is different from other disciplines
The stakes are high in life science manufacturing compared with other industries. Mistakes and nonconformities in end products can cost lives.
It is recognised that quality cannot be ‘tested into’ life science products once they have been produced or assembled - so there is heightened risk at play. For example, there is no way to observe or test the right quantity of ingredients are present in each tablet on a blister pack, or that a medical device has been assembled correctly, without destroying or dismantling them.
Although batch testing is an important part of QC, GMP instead, seeks to ensure quality is ‘built into’ products, through the effective and consistent control of the processes used to create them.
What does cGMP cover?
Current Good Manufacturing Practice, then, includes the various ways in which:
- Effective SOPs are developed, documented and observed throughout the manufacturing process
- Manufacturing equipment is calibrated and maintained
- The risk of product failure is assessed and controlled
- Data about the manufacturing process are collected and stored
- Product history is made traceable from start to finish
The proper observation of cGMP, therefore, ensures consistent quality outcomes and complete accountability in every part of the manufacturing process. This minimises the risk of unsafe and inconsistently manufactured products entering the market.
Regulating the adoption of cGMP
As noted, the exact nature of the processes and procedures required to produce the highest quality drugs and medical devices can evolve and change over time.
But the need to define these best practices, as well as control, monitor and report on their adoption across the manufacturing process is a requirement that broadly stays the same.
The ability to do this, allows businesses to prove to regulating bodies that they are compliant with all required cGMP. As the FDA inspects manufacturing facilities producing drugs and medical devices for the US market around the world, this is particularly important. Inspections follow a standard approach and are conducted by highly trained FDA staff. Businesses must be ready for announced and unannounced audits where compliance is assessed.
cGMP compliance is all about having the tools to deliver control
Companies, then, need to observe cGMP in their operations, while demonstrating through the integrity of the data that they have complied with them. For this, they must have the procedures and tools in place to define cGMP, ensure they are implemented across the organisation and then prove they have been observed.
Digital quality and document management systems bring control
Through proper documentation within a digital Quality Management System, organisations can ensure that cGMP are implemented and evidence of implementation in the design, manufacture and management of medical products is correctly recorded and always accessible.
The right QMS will ensure that:
- Standard operating procedures are defined and well-documented
- Required approval processes and sign off procedures are observed and documented in ways that cannot be forged or tampered with (e.g. through digital signatures requirements codified in FDA 21 CFR Part 11)
- Manufacturing processes can be defined and controlled. Any changes to processes are evaluated and validated.
- Manufacturing occurs in a controlled environment that prevents cross-contamination.
- The history of the manufacturing process is recorded to prove that all required procedures and instructions are properly followed.
- The causes of any quality defects are investigated and action taken to ensure that the defect does not occur again.
The onus is on organisations to understand how the latest technology and scientific techniques can be applied to manufacture products that are safe and efficacious. But the digital quality systems and document management tools you adopt will be the means by which you prove that these best practices are understood and implemented across the lifecycle of a product.