SOP for Line Clearance Before Bulk Packing

OBJECTIVE

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

SCOPE

This procedure applies to the packing department in the Pharmaceutical Manufacturing Facilities of PharmaInfo 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 all previous products from the department.
• Remove all previous products from the department (tablets/capsules/over printed labels/jars /poly bags and shippers).
• Check for rejects of the previous batch weigh and record in B.M.R and destroy as per SOP
• Check for a reworking of the previous batch weigh and record in B.M.R.

ALSO READ: SOP for Line Clearance Procedure for Inspection and Packing Areas

• Attach in-process labels on reworking Tablets and Capsules.
• Attach status label indicating ’CLEANED’ with date checked by (name & sign supervisor) 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/cleanliness of area and instruments and the BMR, Final Line Clearance should be given by the Quality Assurance supervisor.

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 Line Clearance Before Blister Packing