Transcription: Pharmaceutical Supplier Auditing – How to Achieve Consistent Results

The following transcription is taken from The Windshire Group’s webcast “Pharmaceutical Supplier Auditing – How to Achieve Consistent Results Expert Panel Discussion – Live Free Webcast

Good morning everyone and welcome to today’s webinar, Pharmaceutical Supplier Auditing: How to Achieve Consistent Results Expert Panel Discussion. I’m Terri Melvin and I will be today’s moderator. We have with us today three expert panelists, who will first tell us a little bit about themselves and then address the talking points in their particular areas of expertise. Then we will dive into your questions live. I will now turn it over to our first panelist Dr. James Blackwell.

Dr. James Blackwell:   Thanks Terri and thanks to everyone for joining us today. I’m James Blackwell, President and Principal Consultant for The Windshire Group. Our hope today is to make new industry friends and acquaintances to the service and information resource for organizations by providing answers to some of their most pressing questions about this very important and timely topic. Just a couple of House rules before we get started; please don’t ask anything that contains confidential information. Also for today’s webinar, we are not offering any specific advice for anyone’s particular situation and we are not responsible in any way for any use of the advice or opinions we express. After self introductions, we will share a few of our personal thoughts about pharmaceutical supplier auditing and then we will get started with questions. I will then close our expert panel webinar with some concluding thoughts. Prior to becoming a consultant, I held several senior technical positions within industry development and product companies. I have been an industry consultant for more than 12 years, assisting with CMC technical quality and regulatory aspects for products in all major therapeutic classes and at all stages of the product lifecycle. The Windshire Group is a leader in providing expert assistance to development and operating companies. All of our panelists have expert experience on our topic and I would like to now introduce Danielle DeLucy for her self-introduction.

Danielle DeLucy: Hello everyone and welcome to today’s expert panel discussion. I have been in industry for about 17 years, specializing in the areas of quality assurance and quality systems, began my career as a pharmaceutical microbiologist and have held positions such as Product Quality Director, Batch Release Director and then have my own consulting business where I help companies that experience not so great inspections from some regulators and some consent decrees as well. Today I hope that you’ll enjoy our presentation on supplier auditing. It’s a great topic and we have a lot of different types of advice to give to you today to make your next supplier audit a successful one and your quality system pertaining to supplier auditing that much better, I’ll turn it on to Deborah Miller and you’ll hear a little bit about her as well.

Deborah Miller:  I have approximately 30 or more years in industry. I began as a medical technologist in a clinical lab as a laboratory manager and then Director. I served seven years with the American Red Cross. And in that capacity in the Biomedical Division, I worked with a medical device pharmaceutical biologics and performed extensive audit supplier auditing for the American Red Cross. In the past 12 years I’ve been a full time consultant for quality systems and have performed over 30 audits of suppliers and vendors. I’m very interested and anxious to talk to you and share my experiences today. Terri?

Terri Melvin: Thank you Deborah. And now we’re going to go to Dr. Blackwell for his talking points and points to consider for supplier auditing.

Dr. James Blackwell:   Yes thank you Terri. I think one of the most important aspects to consider is that your supplier auditing is a critical activity for the quality of your product. Obviously the type of audits you do should be characterized based on a risk assessment of your CMO’s and your critical and non-critical raw materials and should be done prior to selecting any of your critical suppliers. There’s a valuable tool though throughout the relationship that you have with your suppliers. One of my bits of advice today is try to anticipate mismatches between either the quality systems of your organization and theirs. And perhaps the state that the supplier is in terms of meeting your demands. A classic example is a large company using a small company supplier and sometimes a supplier will need additional support to address your needs. You should ask are critical findings able to be readily addressed? Will they need additional support? We have a current client who chose a supplier because they had to; but that supplier needed substantial resources and they didn’t plan for this and so we had to come in sort of the last minute to do qualification activities, EM program activities and other support in order to continue their clinical trials. Over to you Danielle.

Danielle DeLucy:  Thanks James. Supplier of quality obviously is a very big part of the quality system. You really have a lot of different things to think about when you’re talking about your supplier; technical aspects, regulatory aspects, how they deal with their quality systems, are they going to be responsive to you? Are they local? is it easy for you to get there? and their readiness to accept you as a potential business partner. One of the tools at your disposal is to verify their acceptability is to audit, go out, get a nice team together with some subject matter experts and really start discussing with the supplier what they can do for you. It’s important to know why, who, when, how and one of the supplier audit. It’s one of those things that seem pretty easy when you think about it, but when you put pen to paper and think of all the different parameters that you need to audit when you get to a supplier, it sometimes becomes overwhelming.

So getting a good team together will really help for a successful audit. Another piece that we’ll talk about today a little bit is how you actually go into scoring your supplier. A lot of pharmaceutical and biologics facilities do like to use the scoring method and it’s very easy method for them to get to their upper management so they can take a look at you know if the supplier has achieved a score of 90 percent, so it’s easier for them to take a look to see if that supplier is then qualified. It is also a good tool to balance compliance with the business. Obviously there’s always that business part that our marketing friends and colleagues are interested in, in our supply chain.

So it is very important to balance that with the compliance as well. And then lastly sometimes quality technical agreements are a very good tool to use to help the process make more efficient. FDA does like to see that these are in place with some of the suppliers that you’re working with. It’s just a nice way, you know, there’s any type of issues or concerns, it’s a nice document to go to, to see who to contact and what agreements that you’ve made upfront. So with that I’ll turn it over to Deborah for some of her talking points.

Deborah:   Thank you Danielle. So James had mentioned that sometimes your supplier will be a small company and they may need additional support. I’m going to talk a little bit about the actual setting up and performing the audit. When you have a large company that’s your supplier/vendor and you’re a small part of their total business, sometimes there’s a different issue with them in that the level of responsiveness to you is kind of related to the amount of business they’re doing with you. And that’s another issue that you may have to deal with and understand that your wants and needs, they may not be as responsive because the size of your contract. Having said that, I recommend that you approach the audit and the qualification as a collaborative effort with your suppliers and vendors. It’s not an inspection. You’re not the FDA. You’re collaborating with them to make sure that you have the best outcome for both.

To start with, before the audit, it’s good to make sure that you define a focused scope whether you’re using your own auditors or third-party auditors. The scope helps to steer the agenda and to focus on those areas that you need to focus. You will notice that most suppliers are not going to give you a lot of time for a team of people to be in their organization. I’ve actually audited companies that are audited by customers every day of the year. So you have to be able to focus your scope on those critical areas that you must see and anything else can be added on if you progress throughout the audit timeframe. Part of making sure that you cover as much as you can is to prepare before the audit. Work with your point of contact at the supplier site and find out as much as you can in advance. You may have a checklist where they fill out a lot of detailed information about the company, but also see if you can get a copy of their SOP list. You can see a lot about how they’re structured just by what SOPs they have. I just recently audited a site and they didn’t have change control SOP, so I went, I knew I went in to go and find out how they manage change control with their customers. Once you set up the audit you have the agenda and you are onsite. Make sure that you corroborate. Trust but verify what they say and what they do. I reviewed a system for one company and they said that they were GMP certified. When I asked them what certified meant they really weren’t certified. They hired a company come in to make sure that they were compliant with GMP. Well that’s okay, but you have to make sure that your vocabulary matches their vocabulary so when they say something, it means the same thing to your company. If you prepare in advance and you have a focused scope, and an audit agenda and you corroborate what they’re doing onsite and you drive the agenda and don’t let them spend the whole time giving you a marketing presentation then you should be able to get a good overall picture of your supplier to make a decision about their qualification. Terri.

Terri: Thank you Deborah. And thank you panelists. We will now open it up to your questions. Simply type your questions into the question box. Our goal today is to answer any and all questions. However if we do run out of time and don’t get your questions answered live for some reason, those at development companies and product companies, we will answer your questions after the webinar concludes. What’s nice about this webinar today is we did get some questions sent to us ahead of time from some attendees and I’d like to get those questions answered first. So the first question that was sent in was;

“How do you handle, what is best practice in risk-based audit plans?”

Danielle:    For risk-based audit plan, one thing you want to consider when you’re looking at what risks you’re willing to accept with the supplier I guess is first and foremost I would say is; what I talked about a little bit in my points to consider; balancing that business aspect with compliance. So you may see a risk with the business that they have a great compliance program. However perhaps they aren’t very good on delivery or maybe they’re a little bit too expensive in the business. So you really have to balance that risk. Do you want to have a risk to the business or more of a risk to compliance? Now I’m a quality person through and through. So I would say I wouldn’t risk a lot of my quality aspects of this supplier auditing program or risk any of the compliance that I would expect from the supplier. But some companies do choose to do that. So I guess I would say you yourself have to take that into consideration when you’re working with management. How much risk you’re willing to accept, some companies actually you know they don’t really expect you know a lot of you know strict adherence to compliance with some of their suppliers. Some companies make sure that they have a functioning quality system. It’s working properly. They’re notified of any changes. And they’re satisfied you know maybe with just looking at past FDA inspections and saying that “yep, they’re good to go.” They’re going to give me my product in a timely manner. You know they are cost effective and it’s a product that I need and it’s going to make my process go that much more smoothly. So when you’re looking at risk based auditing it’s really up to the firm to see again how much risk you’re willing to accept. So I don’t know if James or Deborah, do you have any comments?

Dr. James Blackwell: 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.

Terri: Deborah, do you have anything to add to this question?

Deborah: I think they’ve covered it quite well. Thank you.

Terri: Excellent. Great. Here’s the next question.

How do you deal with GMP versus ISO 9001 requirements?

Danielle: I’ll take that one. When looking at ISO 9001 and GMP, they’re not very dissimilar. They do require the same amount of preparation for our supplier audit, they do require that you do audit your suppliers. I would think that, you know, the GMP requirements actually go a little bit deeper when it comes to really auditing the actual process and the manufacturing piece of the audit. I know I’ve been involved in both of these types of audits and, you know, the ISO 9001 does achieve what you’re looking for when it comes to a supplier audit. It does mandate that you have this as part of a functioning quality system that you go out, you know, you take a look at your suppliers, you see what things that they could do better, you document things that you’re in agreement with. And then you provide that report to them. From a GDP perspective and in my experience I’m not sure how James and Deborah have experienced this but I believe I’ve gone a little bit deeper into the process. You know we’ve looked at a few more systems. We’ve looked intently at some deviations and CAPAs, and really see how they how they manage a lot of the different types of maybe issues and compliance concerns that kind of come about. So that it’s a little bit easier to understand their approach to quality. You know in the GMP audit as opposed to the ISO 9001 in my opinion it just seems like more of an on the surface type audit

Deborah: And to follow on with that, just because your vendor is ISO 9000 compatible, it doesn’t mean that you can’t go into the GMP types of assessments. In fact if they’re making a product or providing a service that supports GMP then absolutely I suggest going back to your scope and your agenda that you look at those areas, you may not have an ISO 9001 standard to reference but they also may just have SOPs in place to determine whether they’re following it. The important thing to know is how they are executing those steps that are critical to you, how they are documenting it and how they are communicating that to you and if you don’t have a GMP regulation to cite, you can still work out working with them to make sure that their actions are compatible with your needs.

Dr. James Blackwell: The other thing I would add is that one of the biggest differences is in area of validation where that’s obviously something required by GMP and not in the ISO guidelines.

Terri: Well I think that rolls into the next question is;

How to set limits, is ISO 9001 sufficient?

Danielle: I would say it depends on what you were actually, you know, auditing for as Deborah and James have had said, you know, if you’re looking for. You know, as James said a little bit deeper into the validation of the methods or depending on what product that they’re making, you may want to, you know, go that GMP audit route instead of it’s just the ISO 9001.

Dr. James Blackwell: I agree.

Terri: Okay great we all agree. Here’s the next question.

How do you manage suppliers who refuse to be audited with justification of having an ISO or GMP certification?

Deborah: I would be very leery of a supplier who refused anything upfront. Anybody who is certified, accredited knows that part of the process is verifying and if they are accredited by an ISO 9000 organization then they should understand that and if they don’t I would work very hard to work with them on explaining to them that it would be beneficial for both parties if they went ahead with the approval process.

Danielle: I would have to agree with Deborah. It really puts up a kind of a red flag when you are trying to do business with a potential supplier and they are, you know, refusing anything even if it is even, you know, compliance issues or any of their documentation that definitely does kind of put a bad taste in your mouth when you are trying to establish a business relationship with them. And as Deborah said working with them and trying to get them to understand, you know, if they work with you and you get them in a pretty good, you know, situation, this could be beneficial for them as a supplier bringing you on as, you know, as a potential business partner and could potentially open them up, you know, to more business for themselves.

But certainly, you know, isn’t a very good way to begin a supplier audit relationship by them not, you know, being forthcoming with a lot of their documentation.

Dr. James Blackwell: The other thing I would add is that I would start looking at alternative suppliers as a back up as soon as possible.

Terri: Great. Here’s another question;

Is the quality agreement mandatory for any supplier or could just a purchasing specification be sufficient for low risk material?

Danielle: I would say it depends on your level of comfort with the supplier, for low risk type of things I would say that’s fine- a purchasing specification, but if you’re going to be, you know, engaging and if they’re actually doing a service for you maybe such as a laboratory service or maybe they’re filling some of your product or giving you or providing you a critical piece maybe a critical reagent or component. You know, I would really recommend that you do go to quality technical agreement. As I said in my opening statement I really think that it’s a very good document and I used it before where they really have been very beneficial, when there’s issues, maybe when there’s some questions that arise between who does what. It’s a nice document to say who’s responsible for what. And you know kind of sets up your expectations on that supplier so that it’s in writing and you know it’s a nice document to refer to throughout the business relationship.

Dr. James Blackwell: I would add it comes back to your risk assessment, if you have, for example, Pharmacopeia tested raw materials such as the sodium chloride, do you really need a quality agreement with that supplier? I don’t think so. So it’s determining where that line is between for example those types of suppliers and your critical raw materials in terms of again, as Danielle said, from your risk assessment what you’re comfortable with.

Deborah: And also the quality agreement for those suppliers that are ISO 9001, you can work in the GMP issues that you want to consider there with the supplier and the quality agreement. And so when you audit them, you’re auditing their ISO 9001 certification and you’re also auditing with compliance to the quality agreement that they’ve agreed to. So that’s how you would work if you’ve determined that the kind of service that they’re providing requires a quality agreement

Terri: That kind of wraps up that question. Here’s a really good question:

What if I have a component that is a critical piece of the process but there is only one supplier that can provide it? But they recently failed their supplier audit.

Dr. James Blackwell: Well I would say it’s not a fun situation to be in. I think that’s an example of where you need to understand what it takes to address that criticality to my bullets at the beginning of the talk and work with them on it. It sounds like a situation where if you really need them, that may be a situation where they need additional support from you and you need to consider that because as the question had said, you don’t have a backup. And so you either stop manufacturing or you need to help them fix their problems and you need to work to that. The situation is going to be complex, there is going to be legal issues and so forth. But you know there’s no easy answer to a situation like that for sure.

Deborah: I was recently actually embedded with a supplier who didn’t sell their certification but they had an extensive observations on an audit with lots that needed to get fixed. The sponsor actually embedded me with a supplier to remediate all of their observations and get them ready for reinspection.

Danielle: And I actually lived through this as the sponsor. I’m trying to, you know, qualify the quote unquote failed supplier for a very critical element component of a certain product that we were working on. It took quite a long time but as James and Deborah said, you really need to have that supplier’s best interest in mind. And pretty much, you know, work with them to get them in a state of compliance because obviously it’s going to help you as well. You know, obviously when the FDA or any other regulators coming to your site, they’re going to be looking at, you know, what you’re doing to make sure that your suppliers are in good standing. So it’s definitely going to benefit you as the company who has the supplier onboard you know to get them in a state of compliance so that you yourself don’t get an observation for, you know, utilizing a subpar supplier.

Terri: Okay. Thank you. Now we have a question almost on the other end of the spectrum here.

How often should a supplier be audited if they’ve been an approved supplier for many years?

Deborah: I would say when you develop your supplier approval and monitoring SOP. You’re going to have different categories of criticality of the supplier and in that process of doing your risk assessment you will determine what suppliers need an onsite audit, what suppliers need a checklist. You will determine once they’re qualified the frequency of onsite audits and the frequency of updating their information. And you’ll also be monitoring them and keeping a file on them. And if they continue to comply with your quality agreement and it’s a good relationship then you determine how frequently you need to go in on site. If they’ve had any major changes in leadership or facilities you would probably go in. But in general it’s all part of doing your risk assessment of your suppliers and what the criticality of their service or supply is to your product.

Dr. James Blackwell: For critical suppliers, it’s usually every year in most quality agreements I’ve seen. And then you should have a clause in there that you can go in for cause. So if there’s problems, if there’s regulatory filings there that impact your product then you’re allowed to go in

Danielle: I think they covered it Terri.

Terri: Okay excellent. We’re going to go back. I have another question here, we’re going to go back to people failing audits.

If a supplier refuses an audit or failed an audit and they provide a critical component, could additional measures be implemented to ensure the quality of the product from the customer’s end? How would those measures differ from the measures that the customer would have otherwise implemented and the supplier agreed to or passed the audit?

Dr. James Blackwell: That’s an ugly question. I think, I hate to say it depends, but you know it’s kind of hard. It’s almost like testing quality into a product and it sounds like, and you can’t do that. So if there’s issues there at the supplier and I have to talk about the case of a critical supplier, if there’s issues there and it can’t produce a GMP product or that meets GMP classifications if it needs to, then there’s nothing you can do about that because if they’re not meeting the GMPs, then the FDA considers the product adulterated. There’s nothing you can do to undo that. So I think that’s the spirit of the question. It sounds like they’re not meeting GMP requirements and in which case I don’t think there’s a lot that you could do other than going back to what we said before. If they have issues and you’re highly dependent on them, the fact is that you may have to help them address those issues.

Danielle: I agree.

Terri: Okay please let me know if that answered your question or if you have a follow up question to that. Here’s another question.

Are FDA investigators allowed to view supplier audit reports?

Danielle: It certainly, they can take a look at those. No problem, and they have.

Deborah: Yeah. It’s their objective evidence that your supplier approval and monitoring program is activated and effective.

Dr. James Blackwell: That that’s part of your quality system and that’s part of GMPs.

Terri: So yes well that answers that question, just yes. Here’s another question.

How do we evaluate a quality system if the supplier tells us that we cannot look at the system records like deviations and complaints to protect the proprietary information of their other clients?

Deborah: I’ve actually had this situation frequently with auditors especially if it’s a new supplier and you do not yet have your own records with that supplier. You may not be able to see actual execution of let’s say a deviation or a CAPA for an OOS for in-process QC on a production line. But you can look at their SOPs, the forms that they use to fill it out. You also would be looking at their management reviews in their data on how many deviations they’ve had the time to close them. You can look at change control aggregate data, you can look at a lot of their quality management system information and data without having to look at the individual records in forms of a particular case.

Dr. James Blackwell: Deborah I have a question about that, I haven’t done as many audits as you and I haven’t come across this. But could you ask for what I would say verbally redact that deviation so that they’re reading from it but not sharing any confidential information but nonetheless you get the essential and important details. Could you ask for that to be done?

Deborah: I suppose you could. But you have to first of all it depends on whether they have a hard copy or an electronic system and how much time you feel that you need to spend on that. I have had looked at supply rooms that had quarantine supplies from different clients and they’ve actually put screens up around the other clients and I only looked it on my client’s product. So yes in some cases I’ve asked them to shield the other clients. It really depends on how much you can find out without looking at the record and how much time you want to spend on it. Usually you get a good sense if they’re managing by the other data.

Danielle: And another thing that I’ve done on some of my supplier audits is if they do trending with different types of deviation categories, you can see how many human error deviations or, you know, processing deviations they’ve had. You know, it just gives you kind of a snapshot into, you know, what where they have kind of where their heavy hitter issues if you will. So that is another way to kind of along with what Deborah and James said to kind of take a look at how they’re managing their quality systems as a whole.

Terri: Okay. I have another interesting question here. If you have a question about a controlled process, should a supplier offer to actually make a change to the process during the audit?

Deborah: This happened to me too. I know it was a packaging supplier and I was questioning the pagination of their batch record and they actually sat down at the computer and offered to change the batch record based on my question. I asked them to stop. And of course discuss the control process of their batch record but he told me that they frequently have made changes because the client has asked them to make a change. So that was definitely a red flag for their control and their change control process. But any time anybody tries to change something or fix something while I’m there I always advise them not to do it but if they choose to do it they have to follow their control process. In most regulated or controlled organizations don’t make the change in one day. So no, don’t have them do it.

Danielle: Agreed.

Dr. James Blackwell: Yeah that was a good idea to me.

Terri: Okay, I have another question here.

What should the statement of all audit observations include?

Deborah: Okay I’ll take this one too. It seems like I have these life experiences. Your observations statement in the best case needs to reference the reg or the standard or a line in the quality agreement or line in the SOP. And just state the non compliance with the wording in that reference. Just recently again, I had a company I wasn’t auditing them. I was doing another kind of review with them and they said a previous auditor told them that they had to have the names of their employees on the organizational chart as an observation, and I asked them what standard that came from and they couldn’t answer it. I would not recommend writing an observation that was an opinion or a best practice. The observations should have a good solid reference and only state the objective evidence of how they’re not meeting that reference. Anything like names on organizational charts should go in a comment section if you choose to have that in your audit report.

Terri: Danielle or James anything to add to that?

Dr. James Blackwell: Ya, Deborah is right. You always want to do that where possible. However I have seen a few exceptions to that where they saw practices that you probably couldn’t codify exactly like that because it didn’t exactly speak to the CFR. But nevertheless they were practices that most organizations wouldn’t perform as a part of cGMPs.

Terri: Okay, I have a question about what is best practice. We’ve heard some people have a grading system for suppliers. Do you have an approach to institute a grading system for suppliers?

Danielle: I’ve worked with this quite a bit. And a few of the firms that I’ve worked with and consulted with, it isn’t mandatory to have, you know, a specific grading system. It really is up to the organization. You know, basically the audit report really should say if you are going to use a supplier or not use the supplier, but in some respects the grading system is used to help upper management and some of the business part of the firm decide whether or not they’re going to, you know, if they want to do business with the supplier. So usually if you’re going to use a calculation, you know, a big chunk of the calculation is devoted to quality and then sometimes people add a delivery and a service type of a category of parameter as well. So it is, you know, based just like a report card maybe 90 percent or above would be considered your satisfactory suppliers and then you would then, you know, kind of scroll down after that, you’d have maybe a bucket that would be conditionally approved meaning maybe they have fallen down, you know, on a few of the parameters and then, you know, you might need to go back and check on them. And then there is the other bucket of, you know, not approved which you were, you know, definitely had some compliance and business concerns. So it is a nice, you know, quantitative way to kind of, you know, get a quick look at it how your suppliers are fairing, how they’re doing. But I mean it’s not necessary but it has been, you know, gaining some momentum at some of the firms that I have been consulting with because of the ease of, you know, metrics and showing how suppliers are doing, you know, to those that really aren’t, you know, right in the thick of things such as, you know, the upper management of the quality group.

Dr. James Blackwell: I agree. I think it could be a good practice but I don’t think it’s required.

Terri: Yes. Okay. Deborah do you have anything

Deborah: I’m just agreeing.

Terri: Yea I have a question about what should you include in a pre audit questionnaire?

Danielle: I guess a pre audit questionnaire can do a lot of things for you. You can pretty much ask a number of things, a lot of things I like to ask, the number of people in their quality unit, you know, if they have a quality plan, a mission statement, maybe a quality, you know, what their culture quality really is. It’s always a nice way to determine you know their commitment to quality, seeing how many people really are in their quality group as opposed to, you know, that ratio versus, you know, the manufacturing group, You can ask them for their last, you know, FDA inspection or regulatory inspection. When it, you know, when it has occurred and how it fared, you know, a lot of different things, you could really make it very personal to what you want to know. And also, you know, really kind of customize it for a lot of the different things that you might be going over there, you know, to audit themselves. I’m sure Deborah probably can add a few other things as well and James. I’ve done a few of them but probably not as many as Deborah has with the amount of supplier audits that she has conducted

Deborah: The questionnaire is really a good baseline for all the demographics you’ll have. [Unintelligible] what you have what have on their websites which are not always up to date, so it’ll give some facilities information, you’ll get, as Danielle said any registrations and certifications they have and last inspections and whether or not there were observations. [Unintelligible] If a new company that you are qualifying, to give good baseline for the qualification file and you can ask specific other questions about their processes too. And if they choose not to answer, that’s okay. I’ve had one company the one that was audited every day who had their own questionnaire filled out that they provided which was easier for them to fill in each individual [Unintelligible] took all require client questionnaire and made one big one and submitted and that was really pretty awesome.

James: In addition to what I’ve heard, I always like to see the table of contents for their quality system for policies procedures and SOPs.

Terri: Okay I have one more question here. Any advice or best practices or anything you can tell us about your experience in closing out a supplier audit?

Danielle: First and foremost, I always like to, you know, always end with a thank you to the supplier. I know that sounds kind of silly and obvious but they do usually, you know, put a lot of effort into hosting you and making sure that all the documentation that you have is adequate. So you’re thanking them, listing some of the positive things that you’ve seen. Making sure that they know that, you know, even though you might have a number of observations that there are some positive things that you did see and, you know, then I always say this as part of the webinar associated with this topic. Make sure that there isn’t a whole lot of people in the close out meeting for some reason. You know, those meetings can be very very large and you really want just the most important people to be there. The subject matter experts maybe some of the heads of those departments and just so that they understand, you know, what you’ve found and how you’re going to address it. Also make sure that they know what you expect, how long they have to respond making sure that you know how you want it formatted when they themselves can expect the report from you as well. So let a timeline discussion should occur along with any, you know, elaboration on any of the observations that you may have found. If they have any questions or need a little bit more, you know, dialogue to understand them. That’s the place to do that. I do try to shy away from any type of confrontation about the observations. Usually if you’re there long enough, if they have any questions they can kind of do that before the closing audit. I like to kind of do a quick wrap up every day before I leave, so that any of those observations really aren’t a shock for them during the close out meetings. So those are just a few things that I like to do in the close out.

Dr. James Blackwell: Yeah the only thing I would add is that if you’re an auditor who knows what you’re doing, you should be able to summarize for them what your key observations were because you don’t want any surprises when they get your report.

Deborah: And I would add that most of my [Unintelligible] close out meetings take about 15 minutes. And one other thing that you should have is who the point of contact is for the report and responsibility for responding. And if you’re talking about closing the audit at your company I would also add that when they reply to any observations that you noted that you very carefully look at their reply to make sure that they answered the observation. I’ve audited several companies that the client had accepted the reply to the previous observations and it really was a [unintelligible] statement. What they did with no understanding if he had really corrected anything done in effect [unintelligible sentence] So I would say communicate with them after the report is sent out to make sure that you’re satisfied with the actions they took not just [unintelligible]. And I always thank all of the people that supported it including the people who [Unintelligible 48:00]…

Terri: Great. That’s all the questions that we’ve had submitted. I think we answered everything. Any final thoughts or thoughts I thought we had some great questions today. Danielle, anything you want to add? James?

Danielle: I would just say that make sure that your supplier auditing program is a key part of your quality system. A lot of times some of the Quality Assurance groups kind of get watered down because of the amount of activities that they do with deviations and change controls, document reviews you name it. A lot of the quality people are really kind of maxed with a lot of different things they have to do but make sure that even though you might be a little bit overwhelmed with your own internal, you know, forms and documentation that you don’t forget about those suppliers because, you know, I’ve been through quite a number of FDA audits where it has been, you know, quite a few day discussion on the supplier audit program. So give it the attention that it definitely deserves.

Dr. James Blackwell: But I’d like to tee off Danielle’s point. If you are overwhelmed or you need additional expertise. I know a very good consulting firm that can help.

Deborah: [unintelligible] encounter issues with this or with product that they receive or the delivery people, make sure that you have mechanism so that they can give you feedback on your suppliers that you can call all year. So when you get ready to reassess them, have a good picture of what they’ve been doing throughout.

Terri: Well I just want to thank everyone for all your great questions today and thank you panelists for your expert answers. If you think of the question later we’re always available call us, e-mail us, smoke signals work too, we’ll answer your questions anytime or contact information is on the last slide here to you and I’d like to turn it over to Dr. Blackwell for some closing remarks.

Dr. James Blackwell: Thanks everyone for attending and we hope you came away today with some useful insights and a greater understanding of doing supplier audits. If anyone has any specific consulting needs on this or another topic, we would like to know how we can help. Please reach out using our contact information on the slide. We’d love to hear from you. The Windshire Group looks forward to sharing our expertise with you in the future. Bye everyone.

Terri: Bye everyone. Thank you for attending. Ending the webinar now.

Transcription: Pharmaceutical Supplier Auditing - How to Achieve Consistent Results

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