Hi All,

I would agree with the points made above and believe that they highlight the main pros and cons. I would also agree that it is largely up to the company to decide how they would like to conduct internal audits as it can have a great impact on their future. Internal audits can be a great benefit to allow companies to plan for full audits…[Read more]

Hi All,

Thank you very much for your input on this question. I would agree that when a company’s technologies are updated the GMPs must then be kept up to date. When these updates in technology occur, they can drastically change the way that a process or procedure is run, thus the GMP must match that new process. However I do not have much…[Read more]

Hi All,

I think the best way to make this change is to grandfather in some projects, but making a specific completion percentage for the projects. For example if a DHF is complete and Design Transfer is complete then the project would be grandfathered into the old system, but if it were in earlier stages than that it would not be. This would…[Read more]

Hi All,

This is a very interesting question about the GMP process. I believe that if all companies had the choice between GMP and no GMP, there would be those that choose no GMP. These companies would be able to sell at a lower cost as they would not need to worry about as much regulatory. However those that still maintained GMP would be used by…[Read more]

Hi All,

Yes, I believe that the ambiguity of GMP’s make it difficult for start-up companies that do not have pre-existing GMPs; however I do not believe it simply sets them up for failure. The ambiguity of the GMPs allow for them to setup their company the way they would like, without having to worry they follow each individual standard. While…[Read more]

Hi All,

I would agree that in many products the R&D/Development can be very expensive. However I would say with many products that the introduction phase can be just as costly. If a product needs a lot of marketing to get into the market, or has a lot competition, the correct marketing tools are needed to successfully introduce the product and…[Read more]

Hi All,

Thank you for the question as well as the comments so far. I believe that, as stated above, both interpersonal skills and business skills are needed to close a deal. To give an example, I currently have a colleague who had never worked in pharmaceuticals, but was a sales person within other companies. Working within our company he is one…[Read more]

Hi All,

I have not had personal experience with a product recall; however one I remember quite well is the Toyota recall of many of its cars. The pedals had the tendency to stick, causing many accidents. Over 4.1 million cars needed to be recalled, causing Toyota millions and harming their name and sales. This really shows the great cost that…[Read more]

Hi All,

I would agree with the comments above that each role is important and it is difficult to say which would be most important. However, one that I believe is often overlooked, but still extremely important is the creating the story behind the product. It really provides the benefit and use for a product. There are products that may be very…[Read more]

Hi All,

Thank you very much for your interesting question, I had not thought about this instance in the past. However I believe that it would make the most sense for a company to kill a project if it will not make the company money. If they continue into development and launch the project has the chance to be a total flop and lose the company…[Read more]

Hi All,

I was thinking about the Planning and Development phase of the Product Life Cycle. One of the most important aspect in this phase is the market and the evaluation of the market. Ensuring that the market is a attractive is a key in ensuring that the product will move forward. Another key feature is the feasibility of the project again to…[Read more]

Hi All,

This is a very interesting question that I had not thought about before. As was mentioned above if any changes, upgrades, or repairs occur on a machine it would need to be re-validated. However if no changes were made and the equipment was simply kept calibrated and regular maintenance was done, there should be no need for re-validation.…[Read more]

Hi All,

Thank you for the great question. I feel these classes have greatly benefited me as well. I work mainly in the pharmaceutical side of the industry, with very little done in medical devices. However taking these courses, I have learned much about the FDA and EU regulations. Although I had experience in the pharma industry, I have learned…[Read more]

Hi All,

Thank you for the great question. I feel these classes have greatly benefited me as well. I work mainly in the pharmaceutical side of the industry, with very little done in medical devices. However taking these courses, I have learned much about the FDA and EU regulations. Although I had experience in the pharma industry, I have learned…[Read more]

Hi All,

I would agree that this simulation really shows the importance of having multiple vendors. It will limit delays like this and allows you to always have a backup plan. When only one vendor has been selected, you are putting a lot of trust in one company, where unknown delays can happen. By having multiple vendors you have a much better…[Read more]

Hi All,

I do not have personal experience in this area however I could see why the quality team would argue that when equipment is moved all processes had to be revalidated. Most likely they were concerned that when equipment was moved it would need to be taken apart and reassembled, which makes room for error. Additionally, if it is simply not…[Read more]

Hi All,

I believe that both require full verification of the process, but at different times. The FDA definition seems to be requiring full verification of the process by inspection and test, or 100% testing of a process. However taking: inspection ≈ monitoring and test ≈ measurement, we can see the ISO definition is extremely similar, but doe…[Read more]

Hi All,

After viewing the lecture for this week, I have thought about the IQ, OQ, and PQ for the Syringe Filling Process – filling syringes with an injectible bone void filler.

IQ – meets specs including the amount of bone void filler added to each syringe; the amount of bone void filler fills the syringe; maximum and minimum filling points, u…[Read more]

Hi All,

I would agree with those that stated the SOPs should contain as much information as possible. As soon as something is left up for interpretation, issues can occur. When issues occur and the individual followed the SOP to the best of their ability, it is no longer a user error, but an issue with a procedure. This can cause many other…[Read more]

Hi All,

I would agree with those that stated SOPs should be required during the research phase. Working for a start-up we did not have many SOPs in place. As more were hired we learned the hard way that without SOPs, everyone will be doing things differently and it can cause many issues. One of the first things we realized after having issues was…[Read more]