Line Clearance - What is the ISO 13485 / regulatory guidance?
WEBJun 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 …
Line Clearance Failures and Issues - Elsmar Cove Quality and …
WEBJan 25, 2011. #1. Hi all am working in a medical device company and Line Clearances are a very important aspect to our daily production. Am not a member of the management team just a machine operator who is responsible for line clearances on both my machine and the next to me everyday. Doing line clearances in this area for 10 yrs i have major ...
Batch to Batch Change Over Line Clearance Checklist - The Elsmar …
WEBApr 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.
Batch to Batch Change Over Line Clearance Checklist
WEBApr 16, 2010 · 2) traceability part - which lot and quantities are used for specific batch/manufacturing lot. 3) however, we don't have data about how chemical would behave when exposed to process/environment continuously. (considering the remnants of material earlier batch are continuously in the process or environment for multiple continuous …
Line clearance - Routine components in the prep room for …
WEBAug 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.
Should the Line Clearance include Machine Setup for current …
WEBDec 18, 2011. #1. usually, line clearance is carried out by QA, to ensure that all the previous steps are cleared (avoid mix up and contamination etc.,); then the machine setup (includes mounting new product specific change parts etc, completing the initial runs to ensure desired performance) are taken care by production supervisor.
ISO15378 and PS9000 - Pharmaceutical Packaging Materials …
WEBJul 26, 2010 · There are some topics where ISO 15378 is stronger than PS 9000, for example in respect of the responsibilities of QA, Purchasing controls and Cleanliness. However, Line Clearance and Pest Control are less demanding and the requirements for Environmental Control are left to the customer’s decision.
Clean Line Validation - The Elsmar Cove Quality Forum
WEBNov 26, 2019 · 1. We DO make implants (contract manufactured - we do not D&D); however, the burden of "final clean" was never required by our customer. They do their own sterilization/final clean. 2. I think there is a confusion between our use of the word "clean line." What we really do is an in-process clean of the implants, covered in ISO 19227.
21 CFR Part 111 Label Reconciliation Requirements - The Elsmar …
WEB21 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 ...
WEB2.0 How to Conduct an Effective PFMEA (cont) STEP 1. Team leader organizes the team; defines the goals, methods, scope, responsibilities of each team member; and establishes a tentative schedule. After reviewing engineering, drawings, and planning, team develops a flow chart showing the major functions or operations of the process to help team ...