GMP stands for Good Manufacturing Practice guidelines and it is a set of regulations, which medicine manufacturers have to comply with. It is a part of the international GxP standards but of course, like most of them, there are a few specifics depending on the location. In this article we will review the GMP certification requirements in the UK.
What is a GMP certification?
The MHRA or the Medicines & Healthcare products Regulatory Agency is the agency that protects public’s health by making sure that medicines and medical device manufacturers and distributors within the UK are following the necessary measures for ensuring quality and safety. The way they do this is by amending international regulations to local laws and organizing inspections to prove they have been correctly implemented. It is important to mention that the implementation is required not only for UK organisations, but also for all importers, exporters and distributors from other parts of the world.
All companies that want to be on the UK medicines and medical device manufacturing market need to be MHRA licensed and one of the steps for getting such approval is to get trained and certified in Good Manufacturing Practice regulations.
NB! IF you want to learn more about the topics covered in such a training, please visit this link.
If you are a pharma company that wants to produce a product with a certain manufacturer, here are the three main characteristics you might want to see in your potential service provider:
– Last MHRA Inspection was no later than 2 years ago;
– It has Voluntary Action Indicated (VAI) or No Action Indicated (NAI) rating and not Official Action Indicated (OAI) rating
– A GMP training record and certification of the people working within the company;
GMP certification requirements in the UK
Benefits of GMP certification
As you can see from the previous point, proven track of training of the Good Manufacturing Practice guidelines is a certain benefit when you want to get licensed from the MHRA, because the main purpose of their inspection is to make sure you follow GMP regulations. But especially pharma companies are going to look at your regular GMP certification, as they need to make sure that their products will then be sold on the UK market.
Who should take GMP certification course?
Everybody working within the manufacturing process need to complete such course and get certificate, as this is his/her proof of being aware of the safety procedures of producing a medicine or medical device. Here is a short list of the professions that are directly involved:
– All professionals involved in manufacturing of pharmaceutical drug products
– Quality Assurance and Quality Control professionals
– Operations and Manufacturing personnel
– Validation personnel
– Engineers
– All levels of management
– Service organisations, suppliers, and vendors who serve pharmaceutical industry clients
– Etc.
Is there any difference between MHRA and FDA or any other local institution’s GMP requirements?
There are some local specifics, they are really minor. Good Manufacturing Practice regulations are international standards for quality and control of manufacturing of medicines and medical devices. However, each governmental institution has to implement them into internal laws and structures. This means that the actual regulations are the same, but the timeframes and ways of controlling how the regulations have been followed in a certain organisation is something that depends on the country’s institutions. As I mentioned above even if you are located in India, but the product will be distributed in the UK, you need to comply with GMP regulations and also to be inspected by the MHRA. In this regard, it will be better to have a training record of Good Manufacturing Practice topic that follows UK standards.
How can I make sure that GMP certification is valuable?
Similar to all other certifications within the pharmaceutical and clinical research industry, there are certain details a valid certificate should contain:
– Name of the certified person
– Current Good Manufacturing Practice Training
– Agenda with topics
– Duration of the course
– Institution that is providing it
What does a Good Manufacturing Practice course include?
It includes implementation and mostly practical interpretation of the GMP regulations. The training can be online or seminar or webinar, but no matter what form it is, it has to contain all GMP main topics like:
– Pharmaceutical Quality System
– Personnel
– Premise and Equipment
– Documentation
– Production
– Quality Control
– Outsourced Activities
– Complaints and Product Recall
– Self Inspection
How long is the certificate valid for?
There is no official statement of how often you need renew your GMP certification. It is required to refresh your knowledge of the guidelines regularly but does this mean is not really defined. We can count on MHRA’s recommendation for the Good Clinical Practice certification that every professional should be recertified every 2 years. Of course this requirement would depend on the specific policy of the company.
What to do next?
If you haven’t organised a Good Manfucaturing Practice Training within your organization or haven’t obtained your individual certificate, you can do this at any time choosing form the wide range of online courses, seminars or even In-house training options. We at Astra Nova also cover the three forms of certification. Here is where you can find some customized GMP topics and you can find free full preview of our GMP online course.
