SOP For Line Clearance (LC) of packing process is described in this post which you can follow in the section of the Quality Assurance Department.
OBECTIVE
This Procedure defines the responsibilities and guidelines for packaging line clearance according to cGMP requirements to avoid mix up.
SCOPE
This procedure is applicable to Production and QA Department
RESPONSIBILITY
QA Officer
Production Pharmacist
ACCOUNTABILITY
Manager Quality Assurance
PROCEDURE
QA Officer checks that the conveyor belt, floor and area around the belt is cleaned.
QA Officer checks that all materials including the finished product and the packaging components (unused, spoiled or rejected) of the previous product / batch have been removed from and around the belt, counted, defaced / destroyed and recorded in the BMR.
QA Officer checks that the required packaging material is available as per P.O.
QA Officer ensured that batch printed labels and cartons for Correctness of product strength, Batch No. Mfg. and Exp. date, M.R.P. Rs. Also check the leaflets for correct product.
QA Officer checks that cleanliness & clearance of belt and adjacent area has already been certified by belt incharge and packing officer and P.O. has been signed by packing officer.
QA Officer checks that the product to be labeled / packed is properly labeled and bears Q.C. release slip for packaging and ensure that BMR is fully completed and signed before giving line clearance.
QA Officer checks that everything is in its proper place and materials are stocked in safe and proper manner.
After satisfactory checking QA Officer gives clearance for the packaging operation and fill the line Clearance check list in BMR.
QA Officer will check and confirm that all the requirements for the line clearance have been
taken care of, however frequent checks at various intervals would be made throughout the day to ensure the satisfactory correctness of the packaging operation.