Good manufacturing practice compliance for life sciences
When you think about the paracetamol you take to alleviate your headache or using a thermometer to check your temperature, you don’t expect there to be anything wrong with them or the way that they were produced. You wouldn’t imagine that the thermometer could fall apart as you put it into your mouth or the paracetamol to have somehow been replaced by a sugar pill.
One of the reasons that it is so rare for anything to be wrong with your pharmaceuticals or your medical devices comes down to Good Manufacturing Practice (GMP) compliance and the regulations that enforce it.
What is Good Manufacturing Practice?
Good Manufacturing Practice (GMP) is a set of quality assurance principles and guidelines that are followed in the manufacturing of pharmaceuticals and medical devices, food and beverages, cosmetics, and other such products. It is the minimum standard that a manufacturer must meet. These practices ensure that products are consistently produced and controlled according to established quality standards, minimising the risk of contamination, errors, and deviations.
GMP helps organisations eliminate loss and waste, save time, avoid fines, and prevent product recalls and the associated bad press. GMP covers various aspects of the manufacturing process, including personnel, premises, equipment, documentation, quality control, and quality assurance.
We’ve spoken previously about how customer attitudes towards quality and safety have shifted, particularly in the recent tough times that we’ve all faced. Prices are higher, but so are customer expectations. People are resigning themselves to things being more expensive, but they want better products and service for that extra cost. Likewise, the consumer memory is long and bad news has a extended shelf life. If you would like a deeper dive into this very topic, you can download our exclusive report: Building trust in uncertain times.
GMP and life sciences
GMP within the life sciences is particularly important because even small errors in the way pharmaceuticals or medical devices are produced can lead to catastrophic medical consequences.
Good Manufacturing Practice - Pharmaceuticals
GMP in pharmaceuticals ensures that the drugs that we take have met the standard of quality and consistency for safe consumption. It ensures that consumers take the right medication, at the right dosage. With food, you can sometimes tell if a product is not safe for consumption. Perhaps the ready meal you buy has a foul odor, or you see mould growing on your chocolate bar. With pharmaceuticals, that same visual check often isn’t possible. Consumers are taking for granted that their medication is safe and effective.
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Good Manufacturing Practice - Medical Devices
Any device intended for medical use must also demonstrate Good Manufacturing Practice. Additional attention is paid to devices where medicine is used in combination with a medical device. GMP ensures that medical devices are produced to the same consistent quality standards, minimising risk. It’s worth mentioning that ISO 13485 is the dedicated ISO standard for medical devices, and whilst there is some crossover between ISO 13485 and GMP, including the use of a QMS, they are separate requirements.
GMP requirements - who are the regulators for GMP
Naturally, each country has its own regulator when it comes to GMP, with the World Health Organisation (WHO) setting an international standard that influences each nation in its individual GMP regulations. Here are some of the more influential regulators in the space:
The Food and Drug Administration (FDA)
The FDA is the regulatory arm of the United States Department of Health and Human Services. The FDA develops and enforces GMP regulations for pharmaceuticals and medical devices marketed in the United States. In addition, The FDA conducts routine inspections of manufacturing facilities to assess compliance with GMP regulations.
The FDA's GMP regulations are often referred to as Current Good Manufacturing Practice (CGMP). This places an emphasis on the necessity for manufacturers to use systems and technology that are up-to-date and modern, in order to be compliant.
You can see the FDA CGMP regulations here.
European Medicines Agency (EMA)
The EMA coordinates inspections to verify compliance with GMP guidelines as set out in Commission Directives 91/356/EEC, which governs the guidelines of good manufacturing practice for medicinal products for human use.
The EMA is involved in:
- Organising the preparation of new and revised guidance on GMP;
- Creating a shared interpretation of EU GMP requirements and related technical issues;
- Developing EU-wide procedures on GMP inspections;
- Facilitating cooperation between EU members for inspections of manufacturers outside of the EU.
When an organisation wishes to sell a medicinal related product in one or more EU country, they need to gain ‘Marketing Authorisation’ from the EMA. Marketing Authorisation holders and applicants need to use the EMA’s IRIS system to communicate with the EMA on GMP inspections. The IRIS system works to automate various processes in communicating with EMA. The platform can be used to submit requests, share information and access scientific advice, and deliver documents amongst other things.
GMP and GxP
GMP is just one part of a wider ‘Good Practice’ guidelines or GxP. GMP aligns with other related guidelines including Good Distribution Practice (GDP) and Good Laboratory Practice (GLP).
Find out more about GxP in our blog here.
Your guide to GMP compliance
The EudraLex, volume 4, Good Manufacturing Practice (GMP) guidelines has nine chapters:
- Pharmaceutical Quality System
- Premises and Equipment
- Quality Control
- Contract Manufacture and Analysis/Outsourced Activities
- Complaints and Product Recall
- Self Inspection
Ideagen’s Quality Management solution has features that can support you with every chapter of the GMP guidelines. To find out exactly how, download our GMP Compliance Guide.Download now