What do you need to know about the new FDA guidance on Manufacturing Site Changes?
By Deb Bartel,
This post was recently updated on September 19, 2018
Recently, the FDA drafted this guidance document to help the medical device industry make decisions around manufacturing site changes. This guidance is intended to help in managing the time frames for changes in manufacturing sites and the associate changes to processes, methods, procedures, qualifications and validations by helping industry predict when an FDA pre-approval inspection is likely to be required for a manufacturing site change.
Sections related to computers and software:
Section III Part A – Definitions
Part A includes software in the list of medical device components.
Section IV Part A – Site Change Supplement vs. 30-day Notice
Part A requires a 30-Day Notice for three categories of changes to the manufacturing of critical components:
- Change to out-sourcing
- Changing the outsourcing provider
- Change to in-sourcing
Section IV Part B – Site Change Supplement Contents
Part B recommends including the validation or revalidation plan for software used as part of the production or quality system.
Download the FDA draft guidance here: Manufacturing Site Change Supplements: Content and Submission
Not what to make of these recommendations? Talk to our CSV experts about how you might be affected.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
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