SOP for Line Clearance Before Blister Packing

Anonymous June 10, 2021

OBJECTIVE

To lay down a procedure for line clearance before blister packing.

SCOPE

This procedure applies for packing department in Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY

The packing staff is responsible for implementation of the process.

The Packing In-Charge / Q.A Supervisor is responsible for the execution and compliance of the procedure.

PROCEDURE

Remove the entire previous product from the department.
Remove all previous products from department (tablets / capsules/cartons and shippers).
Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
Ensure that all the crevices and nearby area is free from previous product. Ensure that all the PVC/Aluminum foils, gloves and accessories of previous product/batch are removed.
Check for rejects of previous batch weigh and record in B.M.R and destroy as per SOP.

Check for reworking of previous batch weigh and record in B.M.R.
Attach in-process labels on reworking Tablet and Capsules.
Attach status label indicating’ CLEANED’ with date checked by (supervisor name & sign) and previous product name and batch number.
Above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
After checking all above points and the BMR, Final Line Clearance should be given by s Quality Assurance Executive.

REFERENCE(s)

SOP : Destruction of rejected products and rejected packing materials.

ABBREVIATION(s)

Q.A : Quality Assurance

SOP : Standard Operating Procedure

No. : Number

P.D : Production

B.M.R : Batch manufacturing record

ANNEXURE(s)

Nil.

REVISION CARD

Nil.