Author: Nigel J Smart PhD

So, when the FDA arrives at your facility, the inspection team will present their credentials, which includes their badge and they will request to see the responsible person. When the responsible person arrives, which is usually the head of the site QA group, they will present form 482 which states why they are at your facility. They will request a meeting to discuss the pending inspection and your job is to escort them to a suitable room that is prepared as home base for the FDA site inspection team. Note; at all times the inspection team will be watching...

So, you’re going to have an FDA inspection? Why is this going to happen? Either you have a registered licensed product or you’re in the process of obtaining a product approval. In each case the FDA will be interested to inspect. In the case of the licensed product; to assure you are still operating according to 21 CFR part 210/211 regulations and various ICH guidelines. Typically, these inspections are determined general GMP inspections, auditing for current good manufacturing practices, (cGMP). In the case of a new drug approval, the agency is looking to assure you meet current expectations for...

The biopharmaceutical industry has come a long way in the last 40 years since the cloning of recombinant DNA was achieved and monoclonal antibodies were invented in 1975 by Cesar Milstein at the MRC, Cambridge, UK. The market for drugs and therapies from the biopharmaceutical industry will top over $400 billion very soon and this puts a great strain on companies to manufacture and distribute those products that are so much in demand. One great development that “caught fire” in the last 15 years has been the advent of the single use methodology of manufacturing. This has not only...

As we talk and listen to clients and customer prospects about what areas trouble them the most, we are constantly hearing about supplier related issues and how they are associated with performance. Perhaps this should not be such a big surprise as the industry progressively moves towards more and more advanced outsourcing strategies, where internal project management of those resources becomes critical. How that is accomplished by companies can vary significantly depending upon the size of the organization, technology products involved and the proximity of the supplier to the customer. However, there are some basic issues which always are...

In todays complicated competitive world of Life Science products, production, which now includes; genes, stem cells and other regenerative medicine products, it’s vital that the systems and mechanisms that we employ are able to maintain reliability consistently. This is true of any Life Sciences products such as pharmaceuticals, but for these broader “Medicine” categories which are employing various human tissues, it’s critical that we perhaps build more robust systems for sustainable compliance. The reason for this is because the possibility of failure isn’t just as easy as rejecting a batch of tablets, it’s perhaps losing a limited batch of...