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 the ambiguity might seem to make the process difficult, it gives them a framework to base their quality system.

-Andrew Nashed

I do not agree that they make the process more difficult for companies or set companies up for initial failure. I think they are essential in order to succeed in the long run. If these GMPs did not exist then any product or company could be in the market and increasing revenue. Regardless how hectic and difficult your job becomes because of GMP, remember that at the end of the day they are there for a reason. They make sure you do not end up in serious and more damaging trouble in the long run.

I believe they serve a purpose and when the company follows GMP and when the PM makes sure everything aligns with GMP, that is when you can successfully complete a project and place it on the market. Its not always about the sales, doing it the right way is also important for any company.

From experience, I’ve found that GMP creates more arguments than anything else within a company and that is because of the ambiguity. The ambiguity lends itself to debate and people tend to get carried away with minor details. Discussions can carry on for hours as people debate whether a step in the process should be labeled as “may” or “should.” As it was discussed in this week’s lecture, knowing the difference in definitions of words such as “shall” and “should” have a large impact on documentation and most people are not familiar with the minor differences in the wording. Oftentimes, with GMP SOP’s, the people writing them may be the experts on that particular machine or process, such as a machinist or technician but these are not the quality assurance personnel that need to ensure that the correct vocabulary is used. In this case, a quality person would be responsible for learning the machine in the way that a technician would because if they did not, they run the risk of using the incorrect word. If you have a technician who cannot explain a process well or a quality person who is unable to communicate or work well with others, it will create an array of problems.
I think that this ambiguity does make it harder for start up companies to initiate GMP without pre-existing GMP’s because it creates a problem of where to begin. The best approach at that point may be to hire an experienced QA person to lead the job but this can result in that person is limited in resources and money. Additionally, the QA person may only be familiar with GMP standards at their previous job and not with how it should be best run at the new start up.

With the way the GMP requirements are set up, it seems that it is trying to make any start-up companies fail. But as mentioned above, the GMP have general requirements to allow any style of company whether it is in the health industry or even food industry to mold and create an efficient process. Also, the GMP requirements was created based on issues that occurred in the past products being improperly labeled or even process inappropriately which caused the public to get sick or even dying from the product. With the GMP rules in place, it allowed to place controls over the manufacture process, packing and the types of drugs/devices based on their classification of low risk to high risk for patients.

Hi All,

Yes, I agree that the ambiguity of GMPs makes it difficult for startup organizations to find the right way to implement them. When I worked in a small organization, We always struggled to understand what should be done. We spent so much money on training and consulting firms to make sure that we understand the regulation correctly and we implement it properly. There were times that we struggled because some of the regulation sections did not apply to us and we were struggling about how would we justify that without falling into the trap of being out of compliance. On the other hand, I also believe that there is an upside for the vagueness of GMPs. This allows for room of interpretation and innovation in application of GMPs. The regulators wanted to leave organizations with some leeway to implement what they understand as long as they are not out of compliance.

I also don't think the ambiguity sets companies up for failure. There are so many different types of assays and ways to create products within medical device and drugs that it's almost impossible to be specific. So it has to be vague, if not regulation would be hard.

I believe in general as a company starts to focus on new processes or focuses on a new project there will always be a learning curve. However, for start up companies due to their size, for the most part you see these companies using outside vendors or companies to manufacture their products. The startup, since it is still relatively new and small, normally do not have the resources or manpower to manufacture in house, so they outsource the process to a company/vendor that has manufactured products before. This is common with using manufacturing plants in China due to the cheaper labor. However, over time as the company gets bigger or most likely acquired by a larger conglomerate do you see the startup adopting the conglomerates processes, which include their manufacturing processes.

Ambiguity of GMPs for start up companies are completing understandable, I believe that is is a learning curve for these types of companies, because their product is being initialized in production and there are no pre-existing GMPs nor standards. As these GMPs are created, the standards will improve. So essentially vagueness of GMPs in the startups companies, allows the room of interpretation, which then innovate the creation of GMPs and decrease vagueness.

Chris

Yes, I do believe that the GMP’s ambiguity does make it a lot more difficult for startup companies that do not have an existing framework of general requirements to follow. The ambiguity allows for debates to arise and it makes the company question “where do we begin?” Due to the uncertainty, the company would struggle, and ultimately find a way to properly understand regulation, by investing in training and outside firms to make sure everything is in compliance. However, in the long run, it will allow the company to follow their own standard and innovation of product, but it still gives them a framework with requirements on their quality system in order for them to not be out of compliance.

It is true that for startup companies not having preexisting GMP as a foundation it will cause a lot of problem, like everyone has mention in this post. What we need to look at here is that even though it would be hard since GMP are like framework with general requirements, maybe if startup companies would try to get some of the GMP from other companies that might be working in the same product but than this might raise another problem I believe. That’s is why I believe a lot of startup companies have difficulties because if they don’t have GMP and let’s say they making medicine, this will maybe give poor quality medicine which not only it would be health hazard, but a waste of money for both government and individual consumers.

GMP's ambiguity does make it more difficult for startup companies. These companies could have the required description in order to have a compliant quality system but they do not have an pre-existing framework that they could follow. Therefore, creating quality document, SOP's could be challenging, since the terms used in these documents needs to be properly used, other than that you could have people doing extra and unnecessary work, it could also mess up your system. Nevertheless, they have the chance to mold this GMP and adapt it to to fit to your company business.

I feel the ambiguity does just that, provide a framework for these companies. Since there is at least a base in place, each company can then place their own quality and SOP in order to comply to GMP's. Each business/company is different in its manufacturing process and products, so applying a strict set of rules would hinder growth in the industry rather than promote a better business model.

Indeed the ambiguity of GMP's pose an issue with start-up companies that do not have a good foundation in a quality system. Ambiguity can be problematic in terms of having departments agree on a solution, the ambiguity can cause internal debate depending how the individual interprets the general requirements. Having the GMP's vague is to allow each company to generate it's own framework system to satisfy the GMP requirements, the forces all companies to put resources in generating a unique system. In addition, companies are not limited to creating guidance documents to further assist in understanding the GMP general requirements, in fact FDA and ISO encourages this. My opinion in this is that , if all companies could copy and paste their quality system from one another, the value of GMP in general would be devalued and not much attention would go into it because it would be mainstreamed.

I agree with @tme3 that the ambiguity of GMP's could actually be beneficial to a startup because it allows for a little more flexibility to create their own quality system and since each company is different with different products there would inevitably be different manufacturing processes. I also agree how others have stated that for a start-up it with no pre-existing GMPs, it would be difficult to know where to begin on how to build their own system in accordance with FDA/ISO requirements. However there are companies and consultants that start-ups could use to obtain guidance on where to begin and can develop nd implement a streamlined, cost-efficient quality plans. One example of a company that does exactly this is called Compliance Gurus. Overall, I don't this ambiguity makes sets them up for initial failure, but rather the ambiguity could be seen a positive attribute that allows for more flexibility into creating a quality system that is right for that company. I think it could be more difficult process for start-ups that don't have pre-existing GMPs, but they could receive guidance from other experts/consulting companies that could help them get started.

compliancegurus/medical_devices