In Reply to Parent Post by John Martyn
A quick question with regard to line clearance. What is the regulatory guidance on line clearance? It is not very well highlighted in ISO 13485: 2003 but yet is a critical tool to prevent mix-ups and ensure traceability, etc. Can anyone point me to guidance docs/ regulatory docs for use in creating a policy?
All help greatly appreciated.
P.S. Thanks Al for your redirection. Much appreciated.
Welcome to the Cove
Yes, Line Clearance is very much required as per FDA and is mentioned under "PRODUCTION SYSTEM" and "PACKAGING AND LABELING SYSTEM" in Compliance Guide
. FDA insist on having a procedure for Line Clearance and Documentation resulting there from.
For your info, I got this procedure and templates on Line Clearance titled -
SOP - Procedures for Line Clearance, Line Opening and Line Cleaning
Though not explictly mentioned in ISO 13485, I feel it is mandatory as ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory