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 companies who would like to ensure quality throughout their processes.

-Andrew Nashed

That’s an interesting question. I think that companies everywhere would be extremely happy to save the money, time, and hassle of going through GMP processes but ultimately, I think that something else would take its place that would not be required but make a company more competitive to have those standards. For example, similar to how the CE marks are in the EU. Companies with these marks on their products become a more trusted company for meeting certain standards.
Personally, I’m not sure if I would want to purchase a medical product that was not up to some sort of standards, whether it was GMP or something else. When you think about it, without GMP standards, the knee replacement that you could be getting could be dropped on the floor of the production hall, picked up, and put into the packaging and put directly into you, bacteria and all, without any sort of check or requirement that it not be covered in pathogens or chipped while being made. The same goes for any food that you would ingest. A fruit drink may be made on a milk shake machine prior to it being produced, but without GMP cleaning standards, your fruit shake will taste milky because it has the flavoring/taste of the previous product.

Agree with your input. This takes us back to the importance of GMPs. Yes they may be time consuming and hectic but the people who came up with GMPs did it for a reason. If there was no GMPs or if companies had a choice then they would only look at the business side of things and not worry about ethics. There are companies who if given the choice would still make sure they are going though the right pathway for their product and not just worried about increasing revenue. While other companies may not care about doing it the right way and only want an increase in revenue. And the GMPs makes the customers more confident and comfortable in using the products.

That is great input to this discussion so far. To add to the idea, the GMP is definitely required to also ensure that the product being sold is consistent. If the documentation used to make the product didn’t provide the necessary instructions and details, it may cause the production working to make a device with drastically different dimensions. In addition, due to the lack of specificity of the product, it may lead to other issues such as mislabeling. For example, if a patient is in surgery and the surgeon picked up a medical device based on the size that would fit the patient. If the label is incorrect, then the surgeon is giving the patient a device that would not work to the best of the ability and would not fully benefit the patient. Lastly, tying that idea to what was explained above, the customers for the products will make sure that the device is high quality with GMP regulated to prevent any further issues.

Hi All,

This is a very interesting discussion so far. I want to look at this situation from a different prospective. If I am a manufacturer that is looking to buy some parts or equipment from a supplier and I have two suppliers that could produce these parts. If one of these suppliers follows GMPs and the other supplier follows no GMP, I would most likely choose the supplier that applies GMPs. One of the main reasons for choosing a supplier that follows GMPs is that GMPs ensure that the quality of the product meets and exceeds expectations at all times. This means that all the supplier processes are in control and no unexpected issues are anticipated. On the other hand, the no GMP supplier will have processes that are not in control and not predictable. This could lead to a compromized part integrity/quality.

-Fady Khalla

Hi I also agree that it would be more of a60-40 situation where maybe 40% of companies would chose no GMP. Yet those who do will have a competitive advantage in the market and have more trust from the consumer. So ultimately there will still be companies who decide to use GMP guidelines.

As the others have mentioned, if there were no GMPs I believe most companies would not follow the guidelines set forth for good manufacturing processes mainly due to the money. Focusing on following standards makes for extra resources and time, which the company can save on if there weren't GMPs. However, the reason they are there is to create a standard and to make sure each process is optimal and there are no backdoor ways in creating a good product. Due to this, if there were no GMPs I believe that another alternative guidelines or standards would rise up in its place. In the end, it is about saftey for the consumer and not following any sort of proper standard puts the company in jeopardy if the consumer is affected negatively and they decide to sue.

In a No GMP aspect, I use to work for a company that did not utilize GMPs, and the process to upscale a potential product from lab to production became difficult at times, because methods that could replicate the lab scale were not utilized and it was very inconsistent in the amount of raw materials used to make these batches. At time it became difficult to replicate processes because certain products did not have adequate documentation, as a result often times we relied on the experienced formulators for additional instruction on these products, in GMP area, everything is very structured and it can be reproducible. Essentially everything is in control, structured and organized with GMP's.

Chris

GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. so just thinking to have no GMP in a company only disaster could occur in the long run for the company and it will just do more damage than what it could be save. so is very important to just have GMP at all cost.

No GMP will certainly result in a cheaper process and the product will also sell at a lower price. Nevertheless, GMPs is what establish your credibility to other organizations, to your customers. It proves that you are a viable supplier of the product and that your product is being consistently produced with quality, integrity and there will be no compromised products that could affect the customer. Therefore, if I had the option between GMP or no GMP, I would chose GMP, since it will show that we can produced consistent, safe and quality products. Also, as said in previous postings, a company with GMP will have a greater advantage in the market since customers will trust your product more.

I agree with other students’ input in regards to companies choosing to not have GMP. GMPs typically cause companies to invest in a large sum of money, and to go through the hassle of understanding the regulatory system and requirements needed to fabricate proper medical devices. However, although there are advantages to not having GMP, there are also disadvantages. If no GMPs existed, then a company would not choose the proper and most ethical way to do business. At the end of the way, they would be concerned about producing a high revenue, as opposed to following standards and making products that will make both Quality and customers happy. It’s all about the safety and efficacy of a product!

I feel GMPs purpose is noble, but in practice it is more of a hassle to a company rather than a benefit to a consumer. GMPs can force companies to take the necessary measures, but I feel that most companies today adhere to these standards regardless of GMPs. this can be a result of the existing framework or maybe this is necessary to keep these other companies "in check" if you will.

Companies should not have a choice as whether they have GMP’s or no GMP’s. The GMP lays the foundation for the company with a set of regulations that it needs to follow. This will provide order or organization to how the company functions. With no GMP, the company has no requirements set and it lets everyone do as they please. In addition, if something goes wrong or needs to be reviewed, this will give a framework as to where to look within. In addition, with GMP it ensures better quality of the products. Without GMP’s, companies will not feel as obligated to create their products to certain standards. They will do what will be most cost efficient and simpler for them, instead of looking as to how to improve the product.

There are both pro and cons to GMP. The major pro is that it assures that the identity, quality and the purity of the product is legitimate and that it requires manufacturers by abide by strongly. But the downside of this is that in order to achieve those point, a robust quality system, a strong strong supply chain management and risk mitigation has to be installed. All of this requires a price and more time. The more time a product spends inside the warehouse is generally going to get more expensive. Although, cost is a considerable downside of it but still GMP's are very much required in order to maintain a minimum standard of quality. The user is satisfied that the product reaching them is safe and effective.