Things to Consider for Medical Device Manufacturers when Relocating

Recommendation

29-31 March 2023
Heidelberg, Germany

The Validation Manager in the Pharmaceutical Industry

In December 2018, the FDA  published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?

The 16 page document is aimed at the industry and FDA staff. The document clarifies:

• What a relocation of the manufacturing site is.
• When to submit a Premarket Approval (PMA) supplement.
• Which documents have to be submitted.
• When the FDA performs an inspection prior to the relocation.

Regarding the questions named above, Section A entitled "What is a manufacturing site change and when should it be submitted as a site change supplement versus a 30-Day Notice? " delivers very helpful information. In addition to an explanatory introduction, a table helps answer the questions. It lists examples of different types of site changes and indicates whether this change requires a site change supplement or a 30-day note. The examples are further described in a very practical way.

Section B of the guide describes in detail what should be included in a site change supplement, including any necessary validation or revalidation activities (Master Plan). Section C describes how the FDA determines whether an inspection may be necessary.

Definitions of the terms used in the document round off the guidance.  

For further information please see the FDA Guideline "Manufacturing Site Change Supplements: Content and Submission".