Author: Nigel J Smart PhD

At a time when we must be efficient to remain competitive, it is important to set the correct strategy in place to drive that success. This success is both financial and quality compliance related, so it is important to accommodate drivers that address both concerns. Interestingly both are closely tied together so if you are careful with your planning and execution, you can reach your own form of operational near nirvana that can put you in a dominant position in your market. So, with this as the goal let us summarize an approach that can bring success.There are some...

It is important during an inspection to have a well-oiled strategy that has been honed and practiced with the site inspection team. To do otherwise will surely get you into trouble and that could be costly both monetarily and in terms of establishing a good compliance record and credibility with the regulatory agency.In preparation for your inspection it is important to know what the FDA inspectors can request. Only if you do that will you stand the chance of navigating the process successfully.So, what can FDA request?They can request to look at documents connected with:1. Equipment2. Materials3. Products4. Labeling5....

So, here we are amid a pandemic that the planet hasn’t witnessed the like of for a century! Not only that, but the planet decided to close itself down in order to fight the scourge. But did it really? Our own industry was deemed essential, so we have been requested to keep functioning of a fashion, employing creative approaches which in our case involved using remote technology. Today, many in our field of therapeutics development rely on contract development organizations to develop their processes, make clinical lots and if all goes well, make material for product launch and commercialization....

So, what are some of the things that we need to do to get ready for the next FDA inspection?First of all, we need to get into the habit of holding practice sessions so that we can drill anything and everything that can come up in the inspection process. It’s a good idea to look at the historical review file that will have been recorded from the last few inspections as this will give you a good idea of some of the things that the agency has an appetite to look at. If we know of areas of weakness...

The FDA will look for entry points into your Quality Management System as a mechanism to highlight potential issues. Some key examples of things that will be looked at which often provide willing entry points includes: Deviations and logbooks. Laboratory errors. Change Control records. These are all records and documents that provide a primary route into finding the things that are wrong with your system of manufacturing. From these records the investigator can drill down to discover further issues and problems by looking at the following. Investigations. CAPAs and whether they are closed out if effective. Training records. Maintenance...