The purpose of this SOP is to lay down the procedure for handling of different type of labels ( Label Control) in production department.
This SOP is applicable for handling of different type of labelsat manufacturing facility.
- Authorized designee of user department is responsible to maintain thestatus label in department.
- Head- user department is responsible to ensure status labeling in department.
- Head Quality assurance is responsible to approve the SOP.
- Type of labels:
- IN PROCESS label is used when product is in production cycle and ready for next stage. It is attached with batch record. Annexure-I .
- UNDER PROCESS label is used when machine or product or area is in operation stage of production cycle. Annexure- II
- TO BE CLEANED label is used on machine or container or area just after completion of process of production at a stage. Annexure-III
- CLEANED label is used when area, container or equipment are cleaned and ready for use. It is attached with batch record. Annexure- IV .
- UNDER FUMIGATION label is used when area in under fumigation. Annexure- V.
- UNDER MAINTENANCE label is used when equipment is in under engineering department for maintenance. Annexure- VI .
- REJECTED label is used on material, machine or any other kind of material that is not to be use or discarded. Annexure VII .
- DISINFECTANT/ SANITIZER/ CLEANING AGENT label is used for disinfectant solution, sanitizer solution and cleaning solution for punch cleaning. Annexure VIII.
- EXCESS MATERIAL RETURNED label is used for return of excess material (If any) from packaging department to stores department. Annexure IX.
- USE FOR label is used for equipment / container / accessories ready for use. Annexure X .
- BULK FINISHED PRODUCT label is used for bulk released from Quality control department for next stage / packing. Annexure XI .
- Authorized designee of PA shall check and verify the disinfectant container for availability of solution & status label.
- Type of labels:
Trainer : Head – Quality Assurance / Designee
Trainees : QA/QC/Production/Packaging/Store/Microbiology/P&A
Controlled Copy No.1 : Head of Department – Quality Assurance
Controlled Copy No.2 : Head of Department – Production
Controlled Copy No.3 : Head of Department – Quality Control
Controlled Copy No.4 : Head of Department – Packaging
Controlled Copy No.5 : Head of Department – Stores
Controlled Copy No.6 : Head of Department – Microbiology
Controlled Copy No.7 : Head of Department – Personnel & Administration
Original Copy : Head – Quality Assurance
Annexure I : In Process Label
Annexure II : Under Process Label
Annexure III : To Be Cleaned
Annexure IV : Cleaned
Annexure V : Under Fumigation
Annexure VI : Under Maintenance
Annexure VII : Rejected
Annexure VIII : Disinfectant/ Sanitizer/ Cleaning Agent
Annexure IX : Excess Material Returned
Annexure X : Use for
Annexure XI : Bulk Finished Product
Annexure XII : Daily log for filling & checking of disinfectant bottle
- REVISION HISTORY:
|Sr. No.||Revision No.||Change Control No.||Details of Revision||Reason(s) for Revision|
|01||00||———–||New SOP||New SOP|