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Alternative cGMP Compliance Methods for Combo Products, Device Production and Quality System Software Assurance + Warning Letter Breakdown

We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for device companies, and break down a Warning Letter.

Welcome to Insider issue #9.

And welcome to the 118 new life science professionals who joined last month.

Today we’re looking at the final list of alternative or streamlined mechanisms to help combination product developers better comply with current good manufacturing practice (cGMP) requirements.

According to the final list, published in the Federal Register, FDA has responded to six comments from the proposal floated in 2018 and cleared up examples surrounding the expectations for manufacturers when applying the list to producing combo products.

On the device side, we’re looking at a draft guidance FDA issued in September of 2022 on software assurance for computer and data processing systems associated with medical device production. The guidance will eventually be a supplement to the “General Principles of Software Validation” final guidance published in January 2002 and take the place of Section 6 of that guidance, which focuses on the validation of automated process equipment and quality system software.

And lastly, we break down a Warning Letter issued to a US API firm for a lax response to mold contamination and data integrity failings.

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