SOP For Line Clearance (LC) for area/machine is described in this post which you can follow in the section of the Quality Assurance Department.
OBECTIVE
This Procedure defines the guidelines for area and machine line clearance according to cGMP requirements to avoid mix up and to ensure product quality
SCOPE
This procedure is applicable to Production and QA Department
RESPONSIBILITY
QA Officer
Production Pharmacist
ACCOUNTABILITY
Manager Quality Assurance
PROCEDURE
A line clearance must be done in areas where there is a chance of mix-ups of the products and materials.
The area/machine must be cleaned in accordance with relevant SOP for the process.
Correct equipment and correct cleaning practice are two critical factors in the successful operation of area management.
If these two factors are closely adhered to, the area can be maintained within acceptable limits.
For area and machine clearance, two types of methods will be adopted.
If the same product is under process, in this case QA Officer will check that no dust is present on floor, walls, drum etc.
If the product is changed. Floor & walls of the area will be cleaned first with detergent, distilled water soaked mop and finally disinfectant. Electric panels will also be cleaned.
Dustbin will be removed from area, emptied and cleaned. QA Officer will check all parameters & give area clearance.
QA Officer will perform Swab test according to the SOP of Swab Test.
- If the swab test passes, QA Officer will give clearance for further process.
- If the swab test fails, QA Officer will advise cleaning and rewashing of machine.
- After cleaning Production Officer will inform QA Officer to perform the swab test till the clearance is granted.