Follow
OBJECTIVE To provide a written procedure for area clearance and work distribution prior to starting packaging of a new batch.
SCOPE This SOP shall be applicable for Packaging Area.
RESPONSIBILITY/ACCOUNTABILITY
1. Sr. Production Officer/Production Officer shall be responsible for implementation of the procedure.
2. Manager, Production or his/her Designee shall be accountable for training and ensuring implementation of the procedure.
PROCEDURE
*** Production Officer and Supervisor shall check to ensure that:
*** Packaging Personnel are setup in proper work stations provided with proper materials and facility and maintain record in the Batch Packaging Record (Form No. PS001-02).
*** Empty autoclave trolleys are returned to the loading area and indicator tapes are removed from their body.
*** Area is absolutely free from bottles, labels, inserts and cartons of the previous batch.
*** Production display board is cleared off all information of the previous batch.
*** Production documents and control sheets are completed and removed prior to beginning of the next batch.
*** Production Officer and QA Officer shall check the materials and sign the material work order.
