Data Integrity and Quality Culture

[Music] [Laughter] hello and welcome to RCA radio a podcast covering the latest news and challenges in regulatory compliance and quality assurance facing the pharmaceutical medical device and biologics industries I'm your host Erica Porcelli in this episode we're covering data integrity and the focus of global regulatory agencies today I'm joined by sue sheep sue is RCA's Distinguished Fellow and has published articles given presentations and taught training courses on this topic at a number of different conferences sue welcome Oh Thank You Erika it's a pleasure to speak with you today well I'm really happy that you could join us I was hoping that we might be able to start out with you providing a brief history of data integrity and how it's evolved over the course of time well data integrity has been of concern to the global regulatory authorities for quite a while and this goes back to the bar decision in the United States where there was a company bar laboratories which was actually testing into compliance when they were getting out of spec results and so based on some of the background in history the generic drug scandal other activities that were going on in the industry at the time the FDA came up with rules and regulations on how to handle data integrity now there are specific data requirements for to control data integrity and those going to go under the acronym Alcoa al CoA and Alcoa actually stands for attributable legible contemporaneous original and accurate and you can find the references to these specific attributes in of course 21 CFR 211 part 211 so for attributable what we mean is all data generated or collected must be attributable to the person who generated the data for legible it means that your data has to be readable and permanent and that's important because you can't use pencils to record data etc contemporaneous the results are recorded at the time the works performed an original is that it's the original source or document it's not been transcribed but it's the original document that the data was recorded on and accurate of course is rather self-explanatory so these guidelines were put into place as I said with the borrow decision and then as the industry grew and we had more availability to electronic systems and people were migrating over to electronic data collection systems there seemed to be a need to revisit right so recently there has been a resurgence of data integrity problems in the in the industry as evidenced by the number of citations that have been and you can look that up on the FDA website of course so based on this the FDA the MHRA in England the World Health Organization in the pharmaceutical inspector at consortium or group pix we call it pics have all release documents to re-educate the industry on data integrity concept so MHRA came out with their new document in 2015 and then they followed it up that was definitions and guidance for industry and then in 2016 they came out with a draft version FDA came out with the new compliance with cGMP guidance for industry on data integrity and that was in April of 2016 the World Health Organization came out with annex 5 and it was good a guidance on good data and record a record record management kisses and that was in June 2016 and pics of course came out in 2016 with their guideline on data integrity in addition to that the parenteral drug Association released a free document in 2015 titled elements of a code of data a conduct for data integrity so the focus is really revisiting data integrity based on of course the historical perspective but more on what's currently happening in the industry and that's why we're seeing a resurgence of guidelines coming out because controlling your data through the product lifecycle has as I said always been of concern to the global regulatory authorities yeah I know we hear a lot of things you know here in the US on what the FDA is doing and you know some of the issues you know we're finding out about and I think it's very interesting that you know this is a global concern are you seeing any prevalent differences between the approach that the FDA takes versus that of the other global regulatory agencies what I think I would focus on here Chris is going to be mind or differences all of these organizations belong to pics so there is a unified thinking across the globe that data integrity of is of concern I think what I'd focus on more is the similarities in the documents now with the exception of the FDA the MHRA the World Health Organization and Picts have all put in an element of quality culture into their data integrity guidelines which is very interesting because we haven't heard of this concept of quality culture so in the pics document actually which is good practices for data management and integrity and regulated GMP gdp environments so they say they're in section 6.3 they actually have it titled quality culture and they talk about it in terms of management should aim to create a work environment ie quality culture that is transparent and open one in which personnel are encouraged to really communicate failures and mistakes organizational reporting structures should permit the information flow between personnel at all levels we also have the MHRA GXP data integrity guidance and definitions they actually have come up with principles of data integrity and they talk about an organization needs to take responsibility for the systems used and the data they generate and then they go on to say the organization organizational culture should ensure data is complete consistent and accurate in all its forms ie paper and electronic so then you can you can see that they're bringing in the the concept of electronic data think further go on to say the impact of organizational culture the behavior driven by performance indicators objectives and senior management behavior on the success of data governance measures should not be underestimated the data governance policy or equivalent should be endorsed at the highest levels of the organization so you can see how they're pushing it upward in management it's no longer data integrity is just no longer the concern of the quality unity quality control but it's the concern of the entire organization including the highest levels of management and then we have we go back to the World Health Organization or well we go to the World Health Organization their guidelines is guidance on good data and record management practices and in their introduction section 1.4 they talked about the adoption of a quality culture within the company that encourages person to be transparent about failures so that management has an accurate understanding of risks and can then provide the necessary resources to achieve expectations and meet data quality standards then they go on in this document to actually define a quality culture is management with the support of the quality unit notice that they've pulled out management being supported by the quality unit so they're not talking about the quality management they're talking about all management across all organizational levels and all organizational functions being supported by quality they should have established and maintained a working environment that minimizes the risk of non-compliant records and erroneous records and data an essential element of the quality culture is the transparent and open open reporting of deviations errors omissions and aberrant results at all levels of the organization irrespective of hierarchy I think those are so prevalent that concept of quality culture now the FDA hasn't actually tackled this in their guideline but I know that they're very concerned about it when they have been active participants with both its bis PE and PDA in working on documents that try to measure quality culture do you anticipate at some point that quality culture will become embedded in the FDA's current guidance or do you think it will always just be an additional consideration based on what you know you know is going on right now in the industry I think that it it that's a very good question I'm not sure if we'll see it in terms of guidelines we may see it in terms of inspectional practice and I think there's some effort so I can tell you for instance of the PDA has come up with the printer or drug Association came up with a model a tool that measures attempts to measure quality culture at an organization now how this is done is by tying behaviors of an organization to attributes of certain quality aspects and what I can do in this tool walks you through it's kind of like a self audit tool in a way but you're measuring behaviors linking two attributes and so if we go towards some of the behaviors like if we look at understanding quality goals one of the attributes would be impact on product quality and so a behavior would be how your employees understand that and can articulate that thought so this has come out in it I believe it's in final form now and then has already been through the pilot what I can tell you is that over 100 regulators from the MHRA and the US FDA have been trained on the quality quality culture assessment tool that was issued by PDA some of the comments and I won't tell you if they're from FDA or NHRA we can apply the quality culture attributes to improve how we assess firms and non compliance context these are direct quotes from the regulators who have taken the class as industry becomes aware and comfortable with this tool it can be a powerful tool for evaluating contact manufacturing organizations business partners I will consider quality culture when reviewing data from industry this course does does help identify quality culture issues in a company this may help us to evaluate the quality of a pharmaceutical company so I think you're going to see potentially more questions or requests for documentation that show that your management is engaged in this whole quality culture and data integrity issue and one of the easiest places to kind of get at this in your company to address it now before it comes up in an inspection of course is with your Quality Management review and over the management review which is typically put together by quality but in the management review and that is clearly defined what in regulations and guidelines you you know you're gonna talk about personnel needs you're going to talk about downtime on lines scrap rates yield rates any significant investigations that are going on in the in your facility so I think there's an actual easy way to kind of start creating this roadmap of quality culture and that you have it in your organization there's always issue elevation procedures where you have a specific procedure that you need to issue bring two forward two management issues that need to be elevated that are not being solved at a certain level in the organization and pulling that forward all of those current elements should be in existence at a company and they will go those documents if you piece them together will certainly go towards proving that you have a quality culture another area where you could certainly begin to explore your quality culture if asked is in your audit schedules you know are you auditing your contract manufacturers what's your relationship there how do you feed them in nation and work on the resolutions to your audit observations certainly now your internal audits are not typically regulators don't ask for them they just want to know that you did an audit schedule and you held to the auditing performed your internal audits but you can use the information that you gather in your internal audit and how you respond and fix it as again a way to show that you are taking this quality culture seriously that you are trying to improve and that you are working on the information that you've uncovered or revealed through these audits that's very interesting I know that you're involved in a lot of committees and and have a lot of discussions around data integrity and quality culture both nationally and internationally are you finding that there are common themes from country to country with regard to the global agencies or is it really driven from a regional perspective for instance does India experience different issues and findings than say Europe or the US or can you not you're you know can you not even get that granular with it again an excellent question I would not get that granular with it I would say that the data integrity issues being experienced are global and they range from you know purposeful malfeasance data integrity issues where people have knowingly and willingly provided false documentation and then there's the benign neglect or the benign data integrity where they didn't know you know it's the document correction when do you correct a document how do you correct a document some of the traditional ways of data integrity you know the one-line initial date put the reason for the correction some of that ability or knowledge has been lost and some of that is because the people who were experienced at the time when all of this broke originally in the 80s right have moved on retired and we've gone to electronic systems there's a lot of pushes on this that have actually created the data integrity the way it is now right so what are some of those pushes right what are the industry changes that at hat that have happened so we had the emergence of the generic industry certainly since the 1980s we've seen biosimilars coming into play virtual companies are big where they actually don't have a manufacturing facility and they're contracting everything out along with virtual companies we have the rise of the contract manufacturing organization we've had compounding pharmacies now and 5:03 be outsourcing facilities enter into the game a lot of institutional knowledge have been has been lost through mergers and acquisitions and I think the biggest push on this is the emergence of information technology in those electronic systems all of those pushes have created a new landscape for data integrity issues so it's kind of hard to equate it back to the history just to say that the whole industry is struggling as these pushes have come forward and its global because all of these conditions the generic industry biosimilars virtual companies CMOS you know they're all they're global in nature yeah I think that's a really good point and and I if you can I'd like to get your thoughts too on you know leadership within manufacturers you know do they in your opinion do you think they kind of I know everybody talks about data integrity it's a big topic we talked about quality culture but starting at the very highest level within organizations do you think they really understand data integrity what that looks like because like you said it could be correcting a document it could be you know blatant changing of information etc and then subsequent to that how quality culture plays into it as well I think that the senior management or the upper level management at companies is they're becoming more and more aware as the landscape has changed and there have been like I said is PE and PDA have been actively involved in the quality culture issue now this really kind of started this whole push on quality issues equality culture really started when the FDA came out with their original metrics and the metrics this it gets to it's a very complicated issue in terms of the metrics document where they were asking it was kind of a surveillance companies were to submit certain quality metrics to the agency before inspection now the idea of the metrics was to actually get a handle on companies that might be experiencing problems in the manufacturing arena and to be able to ward off what we call drug shortages now the drug shortages so we were that the whole purpose of the metrics were trying to prevent drug shortages from happening and in other words to be able to read the tea leaves and say oh look their investigations are taking too long that might be a signal that they're having some manufacturing issues then it ties into with this concept of aging facilities where we're running you know all the lines being run are not necessarily modern today so what came out of that though was the comps that you can have all the metrics in the world but if you don't have the right culture behind it out they're meaningless so that's when we started to weave in this concept of quality culture and that was back in ode 2013-2014 2015 where this conversation so it's only been four years where we've really the industry has really been pressing on the concept of a quality culture I think the more that we press and expose it in talk about what it means and educate the industry I think you'll see more and more senior level management people adapting this type of approach and an understanding of the links between the behaviors and the attributes and how important quality culture and that transparent environment is and making sure that your data does have integrity through out the product lifecycle absolutely you know when you think about it it does make sense that quality culture would play us have a significant contribution in to the data integrity so yeah I appreciate that insight so do you think you know obviously this is a global this has global sight to it and I know there's a lot of efforts within the industry worldwide to do harmonization across a number of different activities do you anticipate that at some point in the future the agencies will be able to share this data with one another and I know it's kind of a far reach out there but you know as we kind of start to look at some of the programs like you know the medical device single audit program and things like that it would seem as though there might be an effort to perhaps have some data sharing take place in the future absolutely and I do believe that they're beginning this process there are of course mr. mutual recognitions our mutual understandings between different regulatory authorities including the FDA picks is a big part of that the pharmaceutical Inspectorate scheme cooperative in a lot of regulation regulatory authority organizations belong to that and I think that's where we're going to see this kind of unification an exchange of data and concepts on data and integrity I think it's coming and I think that the whole entire industry global wants to learn we do have to understand too that because of the global industry you know there's cultural differences between India China Europe America South America and and so this is going to take some time to get all of the regions of the world on the same level because of cultural issues but I think it will happen I think it has to happen I think all of the regions in the world have to be unified in how they deal with data integrity what it means and how they're going to move the drugs across the border and have assurance that they're of good quality regardless of where they come from yeah that makes a lot of sense I know we're kind of bumping up on our time here and I just wanted to see if there's anything else you feel is relevant or important to share with our listeners today I think what I would leave you with is that quality culture and I know we're talking about data integrity but I would say that quality culture a recognition in your organization bringing that concept forward that your data is only as good as the culture of your company is really an important concept that you need to be able to identify and bring forward issues to your management in a free and open environment and understand that it will be taken seriously I think one of the important elements of that is to really come up with a good solid quality risk management plan where you're going to really look at your organization and determine where your risks are that compromise product quality and come up with an action plan of how to remediate it or if it happens you know what what are your the steps to take at the time that you're gonna remediate it and what I mean by this is let's say you are making a product and you have a sole supplier of an excipient well if something happens to that sole supplier that is a risk that that product could go into drug shortage so why not start now trying to identify a second supplier source for that material that would be part of your quality risk management plan as you look through your product portfolio and then you can bring that to management and begin the process of doing that assessment and kind of remediating that gap and in quality risk management plans are very comprehensive they're liveable breathable documents there's a lot of activity around them and you can't you can't just do it and let it sit you have to do it and kind of comment constantly and work at it and a lot of this and if we do this right if the industry does some of these things right and correct what you'll find is when you come to post approval changes you want to make a change in your dossier it's gonna be a whole lot easier for you to get that through regulatory authorities on a global level because you've taken the time to look at your risk mitigate your risk right and and have the quality culture in place that will help you to get your post approval changes through the system much quicker than if you did not have all these things linked together absolutely I think it'll be interesting to see how all of this unfolds you know in the coming year and moving forward into the next you know two or three years as well sue thank you for taking the time to provide us with your insight I really appreciate your effort this morning to learn more on data integrity and quality culture visit wws CA ENCOM you'll find scientific posters white papers and articles that we published that discuss both data integrity as well as quality culture and thank you to our listeners for tuning in to this episode of our CA radio be sure to subscribe to be the first to know when we upload a new episode thank you everybody

Channel: RCA Radio

Views: 324

Rating: 5 out of 5

Keywords: data integirty, quality culture, FDA, MHRA, world health organization, PIC/S, Federal Drug Administration, pharma, pharmaceutical, regulatory, regulation, quality control, quality unit, biosimilar, generics, podcast, RCA Radio

Id: 0pjGEoQcxMM

Length: 29min 2sec (1742 seconds)

Published: Wed Sep 04 2019