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“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


“…First off for the small companies, start simple and I think that works throughout the company lifecycle. I’d like to paraphrase Einstein here; “Your quality systems should be as simple as possible, but not one bit simpler.” Smaller companies are stretched, even larger companies are stretched, for resources these days. So, know when to reach out for help. Electronic systems have made things much easier for companies to implement and get up to speed, but just having an electronic system obviously is not the complete answer to the challenges here. Some of these are cloud-based. So, they can be very cost effective. Everything used to be paper-based records and I think many of us know the challenges of being completely reliant on those.  Again the good news for all companies is that the offerings have really improved in this area…”READ MORE


“…I’ve seen instances where supervisors have been standing in a laboratory watching someone train another individual with no labels on any of the beakers, and when asked why aren’t there labels on the beakers? How do you know what’s in them? The person says, “Oh, this is just training”, and the supervisor allows that to continue. Simple things like you’re supposed to be wearing PPE and it’s supposed to be wore in a certain way and supervisors will be in the laboratory talking with individuals or coworkers will be working side by side, they’re not wearing their PPE as directed and no one says a word. So what is this? I think it’s a complacency or a familiarity that puts blinders on all of us. And that carries over into our policies, procedures and processes it’s the same thing. We think we know what our procedures say and we think we’re executing them but when you have a deviation and you go back and look at it, if you investigate it thoroughly, you’ll find that the procedure didn’t say what you thought it would say….” READ MORE


“…Manufacturing facilities need to be designed for purpose, and there’s going to be some real challenges here over traditional manufacturing facilities. They’ll need to be flexible, scalable and efficient. The concept of  “what is a batch area clearance?”  needs to change to assist in this close system and should be used whenever possible. Again, good data integration and information technologies is going to be key, and there are systems with technologies out there that even small companies can benefit from and really need to think strategically about that in terms of how the commercial product will be manufactured very early in development….”READ MORE


“Today we’re continuing on the theme of quality in the laboratory – it’s in the details. Things that we think are common sense sometimes aren’t very common. The two topics we’re going to work on today are out-of-specification results/investigation and equipment. So for out-of-specification I’ve worked with a lot of clients, a lot of laboratories and a lot of manufacturing facilities that have quality control laboratories that struggle very much with the out-of-specification results that they’re getting in their QC Laboratories. If you read FDA warning letters, you’ll see that this issue is kind of consistent throughout the industry, both from the point of view of what to do with this out-of-spec results and maintaining that integrity with the information that you finally get from your investigation.” READ MORE


“A lot of times we don’t really seem to take the time to train our employees when we get the word that we can actually hire someone, I know as a director and a manager of a department where I’m constantly asking for resources, because we’re so busy, you get that new person in and you really want to get them trained as quickly as possible. But you really want to make sure that they do have the appropriate window to complete his or her training. You don’t want to rush them into their training. You want to make sure that have a very good grasp of what they’re doing the topic, the actual science behind what they’re doing so that when you do sign them off and let them loose in the laboratory or the manufacturing area that you’re confident that they know what they’re doing and that even if they do still have some questions that you have built up that rapport with them as their trainer, that they feel comfortable to come to you and ask you for help.” READ MORE

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