Procedure for line clearance full details PDF

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Sure, here’s a simplified version of the procedure for line clearance in pharmaceuticals:

Introduction Line clearance is a crucial process in pharmaceutical manufacturing that helps prevent mix-ups of containers, products, or components. It consists of three stages:

1. Clearing This stage involves removing materials or items from the previous production from the line. This includes products, labels, packed products, printed cartons, batch coding, leftover solution, etc.

2. Cleaning After clearing, cleaning is performed according to the standard operating procedure. The equipment is cleaned as per SOP, and the rinse water is sent for analysis to quality control.

3. Checking After cleaning, the line or area is checked and recorded in the batch manufacturing record. Any failure is recorded, and an investigation is conducted. Each process should have a checklist or form for each area or line. The person in charge of clearance should be informed of any occurrences before the area is cleared. After the clearance is given, it should be displayed on the status board or signed and recorded.

Live Line Clearance This process involves placing dummy articles in the line or area after checking is done. If an operator searches for dummies and if all the dummies are not found, then it indicates the need to modify the checklist or procedures. QA personnel should be trained on live line clearance before the procedure is implemented, and the personnel should be evaluated twice a year for their performance.

Stages in Production Involving Line Clearance Procedure These stages include dispensing, decartoning, washing, manufacturing, filling, leak test, batch coding, packing. Before each stage, the area should be checked and cleaned, and any materials or accessories from previous operations should be removed. Status labels, paperwork, stereos should also be removed. All the equipment should be cleaned with a clean status label, and areas should be cleaned with a status label displayed.