I’m often asked “What is the difference between GMP vs cGMP – are they the same? Is one a subset of the other?”
At the most basic level, GMP stands for Good Manufacturing Practice and cGMP stands for current Good Manufacturing Practice.
The origin of cGMP
The cGMP acronym originated in the USA, where the US Food and Drug Administration (FDA) wanted to impress upon drug manufacturers the need for continuous improvement in their approach to product quality. The FDA cautioned against a ‘set and forget’ approach to compliance to the GMP guidelines, wanting manufacturers to ensure that product quality became a core driver within their organisations.
A great example of cGMP is the recently announced planned adoption of PIC/S GMP version 13 by the Australian TGA, which enters effect on the 31st December 2017.
In most other countries, the ‘c’ for ‘current’ is not used as it’s assumed that manufacturers will keep up to date with changes to the GMP guidelines and will be continually striving to meet them.
So formally, for GMP vs cGMP – what’s the difference – the bottom line is they are largely interchangeable terms.
The slow pace of GMP regulation and why you shouldn’t wait for change
GMP regulations take a long time to change. The regulators typically respond to disasters, regulating to prevent a re-occurrence. They aren’t changing the regulations to enforce best practices and new technologies and even if they do, it’s years after they’ve become common place.
Our advice to organisations is to look beyond GMP vs cGMP and adopt best practice long before it’s been regulated. You need to understand your manufacturing process, not just the regulations. Use the Quality by Design principles to build in product quality right from the start. Do not rely on Quality By Sheer Luck and don’t try to add it as an afterthought when you’ve got the manufacturing process up and running.
You may be considering implementing new technologies as part of the Industry 4.0 or Pharma 4.0 approach. Technologies that regulators haven’t fully considered yet. It could be additive manufacturing e.g. 3D printing of medical devices, or rapid microbial methods or voice recognition in manufacturing processes to create paperless batch sheets. The key is to make sure you can prove to an auditor that you understand your process and you’ve built quality into that systems and processes (and have the evidence to prove that it works). If you take this approach then you can advance beyond the GMPs and not be always chasing compliance with the next version of GMP guidelines to be released by the regulators. Plus, you get all the advantages those technologies offer, earlier than your competitors.
The (economic) benefits of adopting best practice before it’s regulated
A great example of Quality by Design is the implementation of Rapid Micro (also known as Rapid Microbial Methods (RMM)).
Traditional methods of microbial detection tend to be labour-intensive. You need microbiologists gathering samples and taking them back to the lab. Then there’s the growing of the microbes in petri dishes and analysis by the microbiologist. It takes at least a day, and sometimes weeks, to get results and if they are bad that can mean a lot of rework for the manufacturing team or sometimes the loss of a whole batch of product.
Rapid methods for microbial detection can be sensitive, precise, and quick. Rather than waiting for microbes to grow and then detecting and quantifying them, Rapid Micro detects unique components of microbes, such as DNA or RNA targets. They allow the quick release of raw materials, the fast transfer of in-process work to the next stage, and can bring finished products to market much quicker. This reduces the production cycle and inventory requirements, and frees up working capital. If you are adopting Lean Manufacturing principles Rapid Micro is a no-brainer.
You can also realise savings through the ability to quickly respond to a contamination incident. Many companies have suffered the negative financial, supply-chain, and brand impacts of having to recall affected products. Imagine if you could recall from distribution centres before they reach customers because you knew about the contamination much earlier.
Affordable technology now exists that allows you to ‘bolt on’ Rapid Micro onto your pharmaceutical water systems (if you are interested you can read this article on Water for Injection by non-distillation). For example, Biomerieux has a VITEK 2 system to help reduce micro testing costs and stock levels. The VITEK 2 system offers fast, accurate microbial identification and antibiotic susceptibility testing.
Sure, the technology is still evolving (even though it was first introduced in the 1960s) and there’s not a perfect RMM solution yet, but despite all the advantages, the pharmaceutical industry has been slow to adopt this technology. It does require capital investment, the cost per sample is higher than culture methods and the validation of RMM can be technically tricky but the potential pay offs are huge. Whilst we highly recommend including technologies like RMM at the process design phase for new plants, seeing how quickly these technologies are bursting onto the scene there is a compelling financial argument to retrofit these technologies into existing plants.
GMP vs cGMP vs Pharma 4.0
If you are considering implementing Industry 4.0 or Pharma 4.0 approaches, it is essential to have proactive discussions with your local regulator to get the benefit of their experience. They often see these technologies frequently used in the Australian operations of international organisations but slow adoption by Australian-owned organisations. The technologies and processes included in the Pharma 4.0 revolution won’t be reflected in GMP regulations for years to come, so don’t want for them to be regulated in, get the advantages now.
If you are interested in learning more about Australian Pharma 4.0, I recommend joining the LinkedIn group explicitly set up for innovation in our Industry. Individuals from both Australian and international pharmaceutical companies are members of this group.
Hopefully you enjoyed this broader discussion on GMP vs cGMP.