If you are considering hiring pharmaceutical contract manufacturers there are certain things that you will need to do. Typically, because this is such a cutthroat business, you will need to sign a confidential disclosure agreement with any manufacturer you even consider. This agreement will typically last anywhere from 1-3 years from the date you sign it and will state that you cannot share any confidential information that is revealed to you to any third party. For instance, when visiting the main factory of pharmaceutical contract manufacturer, you may see drug labels of a specific brand. This cannot be shared with anyone or you will be sued.
Now That the CDA Is Done With…
Now that you have signed the CDA, you can get down to business. Generally, once you can get into the company you will want to talk to a sales rep or project manager who will be able to tell you a bit more about the company, the will let you tour the facility and even work with you on an audit. The audit is done to ensure that the manufacturer is working up to code and that you can feel safe allowing them to handle the samples that you have. Though you likely will not be able to enter the actual laboratory, you should be able to view the work inside either through glass or via camera. If they do let you go into this area, you should definitely not use them as they are not paying attention to sanitary conditions.
Speaking of sanitary conditions, you should also request a media fill. This will help to determine if there are any growths in a vial thanks to a non-aseptic environment. This is certainly another indication that the lab you are considering is probably not the best choice for your products.
These are only a few of the things that you will need to do before you settle on one manufacturer over another. You should, however, keep in mind that you will need to probably do some additional research, like seeking out press releases or other types of information about this specific company online. You may also want to talk to people in the industry to find out their opinion of this particular pharmaceutical manufacturer.
If you are looking for a pharmaceutical contract manufacturer, consider contacting Ion Labs. They can be reached online at Ionlabs.com or by phone, 1-877-990-4466.
Be the first to like.