Episode 25 of CMCLive delved into the PDA- the Parenteral Drug Association, going in-depth as to what this association is with microbiology expert Mike Carroll. Carroll, having over 30 years in the pharmaceutical field under his belt leads to a wealth of knowledge about the field of microbiology. Additionally, Carroll has worked in a variety of jobs within the field, from product development to quality assurance. Carroll has had direct workings with the PDA and has been to a number of their conferences. Using his wealth of knowledge, we are able to delve into the PDA and its impact on the pharma industry. To begin, Carroll speaks on the Parenteral Drug Association, which is considered to be a bridge to help create quality parenteral drugs. These are drugs that are injected into the body by a number of means. Considering the depth of variety of this type of drug, it is a positive to have an association with this focus which can designate different criteria and guidelines for each segment of parenteral drugs.
The PDA holds meetings that have particular focuses on specific aspects of these parenteral drugs. From these conferences come technical reports and regulation reports. These meetings have been going on since the 80s. Of course, as the years go by, the science evolves, and experts are learning more and more. The meetings held by the PDA are a wonderful resource to help experts’ further science. The documents created by the PDA gave a How-to to create these products that would be approved by the FDA.
Carroll refers to the PDA as “The PDA was kind of the bridge. It’s the Parenteral Drug Association – its focus is sterile injectable product. But it’s into all kinds of different things.” The documents from the PDA have their hands in many different facets of the pharmaceutical industry. The PDA and their invaluable documents are not a thing of the past. Even today, these documents are updated regularly and are still essential to many processes and productions of drugs and medical products. The PDA pulls a variety of experts from the abundance of fields to create the documents. There is no shallow research done but rather it is a treasure trove of knowledge from a variety of different viewpoints.
Carrol states, “all of those agencies are also cooperating and looking at those documents, as you know, the guidelines. They're still absolutely relevant and they still carry a lot of weight, as well, they should”. Many people do not realize that these sources are available to them, but the technical reports can be used practically, even on small levels. The hosts of CMCLive and Carroll share a simple example of how the technical reports from the PDA were used in the field. They share, “I pulled out that technical report. And I said, Let's start with this. And we went through the whole thing. And we redid our sterile filling interventions and what they represented and all of it and lo and behold, we got actual discernible data, we could make decisions properly”. Where a company saw a possible dead end with their testing and trials led to the achievement of useful data. With the help of a PDA report, a product that could have been thrown out due to not being safe or efficacious has now been reinvigorated with a new direction.
The reports from the PDA are readily available. These reports can be printed out to be used and referenced at a moments notice, as seen in the example during the podcast. This is not always the case for something such as an FDA guideline. Additionally, FDA guidelines are not as in depth nor function similar to a how-to. Also, the PDA meetings hold weight due to the fact that they consistently challenge the norms and the practices of the industry. Therefore, they are constantly changing the way the pharmaceutical industry functions. There are a variety of viewpoints being discovered during PDA meetings. Expert and agency input is reached through these meetings. This makes clear means for reaching what is expected of you and your products.
In a similar vein, Carroll also spoke on the field of microbiology. It can be intense considering one small micro issue could affect an entire batch of a product. Carroll speaks on the importance of quality within the pharmaceutical industry. Working with drugs, it is important to have people working on it that would be willing to take the drug themselves to ensure its safety to the consumer. Not having that mindset makes one not a good fit for this position. Overall, this ties back to the PDA as the documents they provide help create quality products that are safe for use. Bringing the knowledge of a variety of experts and being able to readily use the wealth of knowledge is invaluable. The Parenteral Drug Association is an integral aspect of the Pharmaceutical industry and the information they curate is gold in this industry. Carroll’s firsthand perspective of the PDA made for an informative and helpful episode of CMCLive. Catch the entire episode here.