There are several technical terms used in the pharmaceutical industry and FDF is one of them. Even laypeople are advised to understand some of the basics so that they can make informed choices when it concerns pharmaceutical products.
However, this article will be more particular about pharmaceutical players. As explained earlier, FDF is one of those terms you need to be well aware of. It is an acronym that stands for the pharmaceutical term – Finished Dosage Form.
This term is suggestive of pharmaceutical products offered in their eventual form to the general public. It is different from the term API which describes the active/major ingredient(s) that triggers the desired changes when the medication is administered.
These are just some of the basic pharmaceutical terms that even laymen should know. And just in case you are interested in knowing the key differences between FDF and API, you can visit: https://www.quora.com/What-is-the-difference-between-FDF-and-API-products-pharmaceutical
Having established that, this article will pay more attention to FDF – Finished Dosage Form. This is because it is a key aspect of the drug production process and many things depend on it. So, service providers that produce finished dosage forms must be up to the task.
We would shed some light on how to identify the right service provider in this regard. The details shared here are important and so you are advised to follow through to the end and pay attention as you do so.
Benefits of Working with a Third-Party Company that Produces Final Dosage Forms
Your pharmaceutical company might choose not to put together the technical and human manpower required to produce medications in their final dosage forms. This is whether it is a fill and finish option or any other final dosage form.
The truth is that this is quite understandable and might even be to your advantage. This is especially for the following reasons:
Avoiding Regulatory Complications
The FDA and many other healthcare-related regulatory bodies across the globe treat final dosage form production separately. This is because you can have it right when formulating the medication and get it wrong when putting it in its final dosage form.
This informs their decision to handle things in this manner. Against this backdrop, you should know that the regulatory processes can be quite complicated. You can decide to avoid the headache involved by entrusting the responsibility to a third-party company.
Meeting Production Demands
Depending on the situation at hand, you might need to produce as many medications in their finished dosage form for consumers. Considering that this is not your company’s area of core expertise, you might fall short of the required production standard.
Just so you know, there have been several times when a large number of medications in their final packaged forms have been needed. The last was caused by the global covid-19 outbreak. For more information about this, you can read this.
The point here is that you stand a better chance of meeting production demands when you outsource this process. So, it could just be the right way to go about your business in the pharmaceutical industry.
Human and Technical Resource Challenges
You would have a lot to deal with if you decide to go actively into the production of medications in their final dosage form. Human and technical resources required to produce will have to be managed.
Also, the challenges that come with managing them will have to be sorted out. The truth is that this could affect your operations in other key areas. As a result of this, dealing with a company that is solely into this operation might just be the right way to go about things.
Criteria for Choosing a Final Dosage Form Company
The benefits of working with professional service providers into final dosage form production have been discussed above. In addition to this, you also need to make sure you work with the right option in the industry.
This is so that you enjoy all the benefits explained above and more. Below are some helpful tips to guarantee you end up with the right company:
A company that is not sterile in its operations can ruin things for you. Although these are some of the things that regulatory bodies look out for before approving operations, you need to make your findings.
Approved for Operation
This is the first thing to look out for before deciding to even consider them. For the record, an unapproved service provider in this pharmaceutical operation is usually bad news for business.
Ability to Meet Your Production Needs
There are times your production demands will be low and also times it will be high. Regardless of your production needs, the right company should be able to meet your finished dosage form production demands.
Wide Range of Services
Working with a service provider that offers a wide range of services usually turns out to be a good decision. So, you are advised to make this one of the criteria during selection.
Impressive Track Record
It is also very important that you check the company’s track record. Asking the right questions in this regard will help you get the right answers and you will be able to make informed decisions as a result. So, you should take this seriously.
We have shed light on how to choose a third-party company that produces medications in their final dosage form. This is in addition to some of the known benefits of working with these pharmaceutical players. You are advised to make the most of these pharmaceutical service providers but make sure you end up with a competent company.