Yes usually an outside contractor can come in and perform the audit. Also can’t employees be trained? I know it is not the same thing but in my company we have a safety audit team that is composed of just regular employees who were trained and they do audits every now and then to make sure we are in line with regulations.

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.

I agree with Fady that this should be a case by case scenario. Depending on how far along the products are. If it is not handled like that a lot of money and time will be spent and it won’t be beneficial to anyone.

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.

Hey all,
thanks for sharing your experience or even things that were in the news.Pfizer also had a recall on three of their drugs in 2014 once it was reported that a container of one drug had some capsules that belonged to a different drug! How scary is that? They recalled lot numbers of all three drugs as they were both produced on the same line.

From my experience and knowledge a lot of things get killed but really get placed on the back burner as priority shifts with the intent of getting back to it later. As Michelle said it really depends on how far along the product is.

This was new to me as I had no idea something such as a product manager existed. I think the most important would be for the to stay on top of the industry and market data as everything else seems standard. Staying on top of the market will help the company make changes as they see fit and most importantly stay competitive.

Completely agree it is a combination of both. While your business training is needed so you know to keep the company first it is all communication/interpersonal skills. That is why they don’t just send anyone to make deals but usually people who are charismatic. Business knowledge or just knowledge of the product in general helps during the…[Read more]

I think the most expensive part will always be the research and development phase as a lot of money is wasted by ideas that don’t work or even scaling the idea up and down. Money is spent from testing, contracting, materials just the general initial discovery. After that once he product is set the cost can be strict as it’s just a game of cheap…[Read more]

Hey,
In my company everytime an equipment that has been validated gets moved to a new room it has to be revalidated IOQ/PQ. Similar to what sns34 said it is due to the conditions of the new location, and anything that could of happened to the machine during the move. It is a very tedious process especially since validation can take days so we…[Read more]

Hm, this is interesting because I thought all validations were essentially a holistic approach. You don’t really validate just one aspect of the product but everything that will touch/create it so in a sense it is always holistic no?

Our validation is done on SOPs, equipment and the assay for the drug. For the assay it is tested a certain amount of times against a standard to make sure it falls within in range. The machines have to be run in a series of custom steps to get them validated as well, along with any SOPs

I think writing SOPs are a very hard thing to do. No only do you not know when it is too detailed or not detailed enough, as the author its hard to put yourself in the shoes of someone who knows nothing about your experiment and needs steps. With that being said too much detail isn’t always a good thing as you don’t want a 30 page SOP as well. It…[Read more]

I think it depends on your department. I work in development so we only deal with DHF and if you were in manufacturing or production it would be a DHR. Also an easy way to differentiate DHF is all encompassing and you can build a device from that but a DHR just tells you the steps it’s been through.

I haven’t used an ECO but I think it is used more in manufacturing/ production and not in development as changes made there are much easier. My only question is if it is a major change what are the following steps? If the device design was altered do you have to conduct another safety test or evaluation of materials or is all that included in the…[Read more]

Hey
I think in pharma as mj34 said it is usually from the patient and Doctors. They provide us with feedback on how the drug is working and any adverse effects. Also on the company end even when a drug is on the market we still do release testing on each release lot so having a strong QA team and process is critical. If reagents are changed…[Read more]

Hey
I think in pharma as mj34 said it is usually from the patient and Doctors. They provide us with feedback on how the drug is working and any adverse effects. Also on the company end even when a drug is on the market we still do release testing on each release lot so having a strong QA team and process is critical.

Luisa gave a very good answer to the question. I will add the while both process focus our the same outcome they are also very different. The design V&V focuses on the design while the process V&V focuses more on the road to the design. it ensures that the SOP is in order and any device of material used that is included in the device is working…[Read more]

I think the DHF is more useful than the tech file. With a complete DHF it shouldn’t be difficult to get the actual design of the device as that is where the SOP is. The tech file is just a snapshot and not that detailed. My assumption is you would use a tech/file for a quick synopsis for a quick filing or something like that.

Hello,
I also believe that a DHF is not a living document from my experience and just from the purpose of it. It is for the initial design and any changes that will be made shouldn’t alter the initial design. Once that happens you have a new device and proper measures should then be taken. The SOP example provided is a tricky one. If the changes…[Read more]