SOP for Line Clearance Before Blister Packing

OBJECTIVE

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

SCOPE

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

RESPONSIBILITY

The packing staff is responsible for the 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 the department (tablets/capsules/cartons and shippers).
• Ensure that all containers, documents, and labels of previous products/batches are removed and the status board is updated.

• Ensure that all the crevices and nearby areas is free from previous products. Ensure that all the PVC/Aluminum foils, gloves, and accessories of the previous product/batch are removed.
• Check for rejects of the previous batch weigh and record in B.M.R and destroy as per SOP.

ALSO READ: SOP for Procedure for De-Foiling of Blisters

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

REFERENCE

SOP: Destruction of rejected products and rejected packing materials.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No.: Number

P.D: Production

B.M.R: Batch manufacturing record

ANNEXURE

Nil.

REVISION HISTORY

Nil.

ALSO READ: SOP for Operating Procedure of Blister Pack Machine