Medical Device & Diagnostic Industry Magazine MDDI Article Index

January 1, 2006

3 Min Read
Validating Combination Products is Challenging

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI January 2006


When working with combination products, teaming up with FDA early is one of the most important steps during the analytical testing and development process.

“FDA is an excellent resource for guidance,” said David Baum, PhD, president of Acumen Pharma Consulting LLC (Raritan, NJ). “The sooner you can get [the agency] involved, the better off you are.” Baum spoke at the MD&M Minneapolis trade show in November.

Analytical testing is a key factor in receiving FDA approval for a combination product. Manufacturers must address pharmaceutical product issues such as content uniformity and dissolution. Content uniformity ensures that the same amount of a drug is present at the beginning, middle, and end of a lot. Dissolution, or elution, testing shows whether the physical consistency of a product has changed.

Baum also stressed communication between manufacturers and chemists during analytical testing. Device manufacturers and pharmaceutical chemists come from two different worlds, and each field uses a different language and rules. For example, chemists follow the good laboratory practice regulation, 21 CFR Part 58, for the reporting of nonclinical lab studies. Manufacturers abide by the quality system regulation (21 CFR Part 820).

Baum stressed that good communication between manufacturers and chemists will make the testing process go a lot easier. “The analytical chemist must partner with the engineer and ask, ‘what are the results that I need to move on to the next step?'” said Baum. The engineer also needs to give the chemist a reasonable time frame for receiving the precise and validated results. Engineers should not expect turnaround within a couple of days.

How Can OEMS Test and Validate Correctly?

Baum offered a few tips to help manufacturers during the testing and
validation process:

• Use a process that is scalable.

• Develop rapid in-process tests to aid in process development. “There's nothing worse than taking a product to completion and then realizing that you goofed,” he said. “In-process testing is important and can save you a lot of money.”

• Feedback time is critical. Getting rapid turnaround requires that device manufacturers and chemists have a good relationship.

• Partner with FDA early.

When developing and validating a combination product, it is critical to know the physical properties of the drug. Validation must be conducted with a protocol and acceptance criteria, so it is helpful to determine whether the acceptance criteria can be met before beginning the validation process, said Baum. To make the process easier, all of these issues can be discussed with FDA early in the development project.

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