How to Implement Design Control for Combination Products within Pharma?

"Design Control" was a term that was originally used only in the development and manufacture of medical devices. In the meantime "Design Control" became an important issue for the development of pharmaceutical drug products just as well (ICH Q8, Q9, and Q 10). There are more and more requirements and requests from the regulatory authorities relating to "Design Control" for Combination Products.

"Combination Product" is a US term and there is even an Office of Combination Products at the FDA since 2002. In contradiction to that the EU has no definition of a "Combination Product", it is either a Medical Device or a Medicinal Product. The decision how to classify a product depends on its Primary Mode of Action (PMOA) and the intended use.

As a consequence with regard to the existing Quality Systems, drug manufacturers may not only follow GMP but also have to fulfil new Medical Device Directive and ISO-requirements for device manufacturers, or in the US a drug manufacturer regulated by 21 CFR Part 210/211 has to add specific requirements from 21 CFR 820 for device manufacturers. In Europe a drug manufacturer may also have to maintain two quality systems (EU GMP and ISO 13485 for device manufacturer) depending if an ISO certification is required.

One impact of these combined quality systems is the demand for a "Design Control" when developing a combination product. The implementation of a complete Design Control Process should follow the waterfall model as described in FDA's Design Control Guidance for Medical Device Manufacturer.

For people working in the pharmaceutical industry it is a challenge to transfer all these new terms (Design Process, Design Verification, Design Validation, Design Transfer, etc.) to their existing and traditional development processes.

It is the aim of ECA's new course Design Control for Drug - Device Combination Products, from 25 - 26 June 2012, Heidelberg, Germany, to give you an overview over the current requirements in Europe and in the US and to show how all these requirements need to be translated in the development of drug - device combination products (pre-filled syringes, autoinjectors, inhalers, etc.) and how to integrate Combination Product development activities within pharma.

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