The purpose of this SOP is to lay down the procedure for handling of different type of labels 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|