Line Clearance - What is the ISO 13485 / regulatory guidance?
Jun 6, 2006 · 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 ...
Line Clearance Failures and Issues - Elsmar Cove Quality and …
Jan 25, 2011 · Re: Line Clearance issues. Hi, blossimhill and Welcome to the Cove! Your post sounds like this is an olde-style Theory 'X' management culture. Changing a culture, particularly this type can be very challenging. In your efforts the …
Batch to Batch Change Over Line Clearance Checklist - The Elsmar …
Apr 16, 2010. #1. Dear All, THis is a query for line clearance. We have line clearance SOP where we have said during batch to batch change over line clerance shall be done by concerned department. Is this needed for campaing manufacturing. As we have modular concept. This system we are following. As modular concept has 10 pages of checklist.
Line clearance - Routine components in the prep room for …
Aug 9, 2004 · Theses common components have all been booked in and inspected, then given an internal identification number. This number is then used to compile the bill of materials for manufacture. Heres the issue. Our production guys would like us to hold certain routine components in the prep room for universal use.
ISO15378 and PS9000 - Pharmaceutical Packaging Materials …
Jul 26, 2010 · However, Line Clearance and Pest Control are less demanding and the requirements for Environmental Control are left to the customer’s decision. (broken link removed) for a summary correlation table of the ISO 15378 and PS 9000 requirement clauses.
Batch to Batch Change Over Line Clearance Checklist
Apr 16, 2010 · On batch over batch, we send "B" batch (in the reactor tank) over the remanent of the "A" batch (in the buffer tank) until the reactor is empty. On this way the machine always have solution to fill bottles, and the reactor is empty to prepare a new solution. So, the new batch, "C" is prepared on the reactor and will be send over the remanent of ...
21 CFR Part 111 Label Reconciliation Requirements - The Elsmar …
21 CFR 111.410: " (b) You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies. Label reconciliation is not required for cut or rolled labels if a 100-percent examination for correct labels is performed by appropriate electronic or electromechanical equipment during or after ...
Corrective Action - Customer Received Mislabeled Parts
Sep 5, 2012 · Take / Issue just the required boxes and labels. Pack and label If any unused labels remain, return to label holding location or distroy. Once a type of parts are packed up and done, clean that line of all the materials (parts and packaging and label stuff) and begin the new task with a clean tabletop.
Labeling and Count/Part Reconciliation - Elsmar Cove Quality and ...
Mar 8, 2011 · So by the time we get to the product labeling station (last operation), we could have 10,000 parts or 19,501 parts or any number equal to or less than what we initially pulled. But we’ve run 20,000 labels because our shop order was cut for 20,000 parts. As an aside, our label count is precise.
Corrective Action for a Recurring Nonconformance - The Elsmar …
Oct 7, 2014 · 1. two parts look identical only a single internal dimension differentiates the two parts. The change we made was to only pull from the bin location listed (i.e. the two parts are different by location). 2. Part number X was asked for and part number Y was shipped.