GMP Consulting And The Drugs Business
Pharmaceutical companies which manufacture and distribute medicines and medical devices must ensure that they comply with current Good Manufacturing Practices or cGMP. The whole aim of GMP is to ensure a high standard of drug entering the market. There are new pieces of legislation brought in to cover GMP all the time as new drugs are developed and technology advances. Without the use of GMP consulting, no pharmaceutical company would be able to keep up with all of this.
A business has two choices; it can employ an in-house GMP consultant whose sole responsibility is to stay up to date with cGMP, or they can hire an independent consultant on a biannual basis. The second choice is the winner for many reasons.
Firstly, it costs much less to hire an independent GMP consultant than it does to employ an in-house staff member. Unless there is a huge medical occurrence, you will only need a consultant two to four times a year. If you were to permanently hire someone you are looking at an average salary of £60,000.
Price is just one benefit of private GMP consulting however. An independent consultant will know so much more about GMP than one staff member. Their technical experience as well as their knowledge of science and drugs is immense. When you hire a consultancy firm you have access to all of their consultants so their experience will far outweigh that of an in-house person.
They can address each area of business. Whenever a company needs to communicate with the FDA or other governing institution a consultant can help with this. If the company is finding it difficult adjusting to new legislation a consultant can help with this. Legal issues are also something dealt with by them. During the validation process consultants can help with records and computers.
There is no way that any pharmaceutical company would be able to stay on top of all the new cGMP regulations and implement them without the help of GMP consulting. There is simply too much knowledge and experience required which a company would have to pay hundreds of thousands of pounds for if they were to hire permanent staff.
If you enjoyed this post, make sure you subscribe to my RSS feed!