Two Things You Should Do Before You Select A Pharmaceutical Contract Manufacturing Lab To Work With

If you plan on getting any more information about a pharmaceutical contract manufacturing laboratory to see if whether they can fulfill your needs, or not, you'll likely need to first sign a confidential disclosure agreement (CDA), that stipulates you cannot share any confidential information that you become aware of with a third party. Typically, these CDA's will last for a designated period of time that is between 1-3 years, on average. Then, when you wish to continue business after the CDA expires, you'll need to sign another.

Now that your CDA is in place, it's time for you to begin your research to determine if a pharmaceutical contract manufacturing lab can complete the projects that you've currently got in phase I, II, or III, but where do you begin?

First, you'll want to talk with a sales representative to see if they are available to meet you at the laboratory for an inspection, or audit as it's commonly referred to. The audit is done so that you can obtain a client services packet to ensure that the contract manufacturer is keeping their methods up to code, and so that you can be comfortable delivering your samples to their facility. During this time, you will also be able to tour the facility and see all the machinery and instruments that will be used to develop your product. Because these facilities are aseptic, meaning they don't carry any dust or debris of any kind, you'll not be allowed to enter the lab, and may only be able to view through a glass window through an adjoining wall. If the manufacturer lets you walk back into the production area, you should not work with them because that indicates they are not conscious about keeping their facility aseptic, and your product could be compromised upon delivery to you.

Second, you'll want to request a media fill prior beginning your actual project. During the media fill, you'll be able to see if any growths form inside the vial that were a result of an non-aseptic environment when filling those vials. The last thing you need is damaged products when you're about to start clinical trials, and this can all be avoided during the initial media fill.

If you keep these two guidelines at the forefront of your mind when choosing a pharmaceutical contract manufacturing laboratory, you should be able to avoid many problems that occur if this initial leg work is not done.

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