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Combo Products: Rules, Regulations, Strategies

As medical device manufacturers partner with pharmaceutical companies or develop combination products, they need to ensure that they have strong quality management systems in place.

At MD&M West on Wednesday, February 11 from 2:45 to 4:00 p.m., James Wabby, director of quality compliance and risk management at Irvine, CA–based Allergan Inc., will conduct a hands-on workshop focused on effectively implementing a quality management system for combination products. In addition to covering the regulatory requirements of 21 CFR Part 210/211 and 21 CFR Part 820, he will explore some of the challenges that companies face in developing and manufacturing combination products. Providing detail about supplier management relationships, he will present a case study devoted to complaint handling and a case study detailing the challenges manufacturers encounter in developing regulatory strategies.

In the following Q&A, Wabby outlines the regulatory environment surrounding combination products and some of the challenges manufacturers face in interfacing with suppliers.

MDDI: What steps should manufacturers of combination products take to ensure that they have a strong quality management system in place?

Wabby: The first step is for the manufacturer to have a complete understanding of the types of products it will develop and manufacturer in a given facility. Once this is understood, the second step is to conduct a gap assessment of the current processes and systems at the facility to be able to meet 21 CFR Part 3 and 21 CFR Part 4 requirements for combination products.

After the assessment has been completed, the manufacturer should revise its current quality manuals, processes, procedures, standards, and policies in accordance with the 21 CFR Part 210/211 drug-quality system standard or the 21 CFR Part 820 medical device quality system standard. Manufacturers that follow 21 CFR Part 210/211 must have in place the six provisions of 21 CFR Part 820 governing the medical device part of the product, while those that follow 21 CFR Part 820 must also have in place the eight provisions of 21 CFR Part 210/211 governing the drug constituent part. There are even more requirements if the combination product incorporates a biologic regulated by the CFR Part 600 series or a human cell and tissue constituent part, which is regulated by CFR Part 1271.

MDDI: Please go into some of the internal and external supplier relationship challenges that manufacturers confront when developing strategies for manufacturing combination products.

Wabby: In working in the medical device industry and collaborating with colleagues, I have experienced a range of challenges in devising strategies for developing combination products, and particularly in working with supplier-management programs both internally and externally. One such challenge is to ensure that all suppliers, including contract manufacturers, have a complete understanding of a product’s regulatory requirements.

We’re often very excited to establish a relationship with either an internal or external supplier, but sometimes, we don’t fully communicate the regulatory expectations associated with a drug or device component—let alone a combination product. That’s one of the challenges to be mindful of when we establish a supplier relationship.

I’d like to expand on the internal supplier relationship because sometimes, the significance of this relationship is missed in the development of combination products. If a midsize or large company manufactures a device constituent part that will be CE marked in the European Union, it might have two or three different quality systems in place that are managed by a notified body. If a company procures a service within the same company but within a different quality system, strong internal supplier agreements must be maintained between the two quality systems. Unfortunately, companies occasionally don’t think that they need to maintain such agreements, although two or three different quality systems may be in place. However, this will create significant regulatory and quality circumstances.

In the framework of both internal and external supplier agreements, a company may also find it challenging to establish explicit expectations related to quality assurance or regulatory requirements when manufacturing a combination product. Manufacturers of combination products are sometimes very hesitant to communicate their explicit expectations with suppliers internally and externally and the consequences of not doing. But if a supplier is unwilling to comply with the various requirements, it could potentially be restricted or disqualified.

Sometimes we focus more on past relationships and agreements with suppliers that offered some type of advantage, such as proximity or a low bid. But because of the complexity of combination products, we don’t want to focus too much on past relationships because we have to ensure that the supplier base can meet FDA expectations around 21 CFR Part 3 and 21 CFR Part 4.

An additional challenge is that within the medial device industry, we often struggle with supplier development programs. Let’s say that we rely on a particular supplier that offers outstanding quality and follows outstanding business practices but needs some development work to meet the regulations for manufacturing combination products. Companies need to maintain a program for helping such suppliers to develop these skill sets.

MDDI: What sorts of regulatory strategies should companies implement to comply with 21 CFR Part 210/211 and 21 CFR Part 820?

Wabby: For medical device manufacturers, the most important objectives in developing a regulatory strategy is to understand not only the type of product they intend to develop and manufacture but also where they plan to obtain approval and make it commercially available to patients. For example, your company has decided that it is going to go to market with a combination product. Are you going to sell it in Canada, the EU, the United States, or the Asia-Pacific region? The requirements for combination products are going to vary depending on the countries and/or regions in which they are to be marketed. Thus, having a regulatory strategy up front is critical. You’ll not only know where your product is going to be marketed, but you will also be able to meet all the regulatory requirements of a particular country and/or region.

Bob Michaels is senior technical editor at UBM Canon.

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