| GMP's very name gives away the answer to this | | | | most important aspects of 'current good |
| question - Good Manufacturing Practice. However, | | | | manufacturing practices' (or cGMP as it's known), The |
| good manufacturing practice or GMP training can | | | | emphasis placed on the word 'current' is deliberate |
| include many different aspects and depending on | | | | and done to ensure that manufacturers and GMP |
| your industry, some areas will be more important to | | | | trainers are fully aware of the importance of |
| you than others. For the medical devices industry | | | | maintaining regular training on GMP. |
| however, all areas of GMP training are important. | | | | In the US the FDA agency are responsible for the |
| It can be said with confidence that GMP training can | | | | regulation of GMP and ensuring its standards are |
| only benefit a medical device manufacturer. The main | | | | widely implemented but in European countries, the EU |
| categories of training include making sure that | | | | has regulatory jurisdiction through the National |
| manufacturing processes are firstly defined and then | | | | Regulatory Agencies, which in the UK, for example, is |
| controlled, that instructions and labelling is written in | | | | called the Medicines and Healthcare Products |
| plain English and that it is neither unclear nor | | | | Regulatory Agency or MHRA for short. |
| ambiguous and that records of the manufacturing | | | | Across the world it is important to make sure that |
| process are kept safely. Also, it's essential that | | | | the local agency's regulatory standards are maintained |
| complaints handling procedures are implemented and | | | | in the GMP trainer's itinerary. It's worth asking for a |
| adhered to by all employees in a fair and regulated | | | | detailed schedule of GMP training before paying for |
| way. | | | | any service - this way it's possible to check that the |
| It is important that GMP training providers offer a full | | | | necessary components are there to enable future |
| and comprehensive service to manufacturers to | | | | good manufacturing practice across businesses. |
| ensure an up-to-date education in the latest and | | | | |