“I see data integrity is really thought of it as the glue that holds the cGMP’s in place. And while the term data integrity isn’t specifically mentioned the predicate rules, you will find the concept of data integrity are replete throughout in the predicate rules. Obviously, Part 11 is a very important aspect of data integrity and there is extensive guidance out there around electronic data and signatures which impact the computer systems…” READ MORE


“I would add that as a scientist and engineer, I think it’s important to understand how their product fits into your product and where there may be some issues or problems in the past so that you can guide your auditor to focus on certain things. You know perhaps it was validation or deviations in those areas. And I think Danielle touched on it as well is doing some research and understanding the regulatory history and if there has been compliance issues and seeing what has been observed there in the past could also help focus you from a risk standpoint….” READ MORE


“..while there is a long- term trend in the industry to more electronic systems, paper records are going to be with many organizations for the foreseeable future. In many of these electronic batch records start as paper systems so it’s important to have well-designed batch records. This enables better batch record reviews and then it also makes a more efficient electronic batch record as well and we’ve seen this from some work in the past, so while released by exception electronic records eases this it doesn’t eliminate the need for batch record review in some form and having a well-designed batch record….” READ MORE


“..It will not be business as usual. That is a sloppy industry, quality and business practices of the past won’t be acceptable. Products need to be right first time and on time. So, in order to accommodate this manufacturing facilities should be designed for purpose which means they should be flexible, scalable, efficient, use closed processing systems wherever possible, and you really need to look for integrating your data and information technologies to assure that we have chain of custody and appliance to our quality standards throughout the supply chain from patient to patient. So, location and size need to account for supply chain and patient delivery…”READ MORE


“..Change can be a number of things. It could be temporary or permanent. You can institute a temporary change if you’re doing some construction in your area in order to reroute traffic and gowning flows. It could be permanent with constructing a brand new facility or doing something else. It can also be routine or emergency…there’s always that interaction between manufacturing, regulatory and quality and discussing whether or not your change can just be implemented as a routine change or if it really needs to get on the docket as an emergency change. It could be serious enough to shut down production or a change that would impact the safety of your employees as well. Change is always happening in the environments we work in….”READ MORE


“..Deviation investigations are a very common topic to be reviewed during FDA investigations. You can scroll over to and on their warning letter page you can pick anyone that they have there for observations and find any type of comments or observations about deviations. Really to have a successful audit, having a solid deviation system and very good, robust write-ups is key. When you have inadequate investigations, as you all know, this could cause some severe issues for the company…..”READ MORE


“…Validation provides documented evidence to support your claims around the robustness and the quality of your product. As such, it is an extremely serious exercise that gets very close scrutiny by the authorities and for good reason. And so, when you are thinking about your validation, you should really be very thoughtful about how you construct your validation protocols, your plans, and how you execute those protocols. When there are deviations from that, they need to be documented correctly and justified appropriately, and things that do not meet the acceptance criteria obviously will need to be investigated, but then constructing the appropriate rationale around that to support the validation and to make sure you can still claim that your process is validated…”READ MORE