SOP For Label Control

  1. OBJECTIVE:

The purpose of this SOP is to lay down the procedure for handling of different type of labels in production department.

  • SCOPE:

This SOP is applicable for handling of different type of labelsat manufacturing facility.

  • RESPONSIBILITY:
    • 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. 
  • PROCEDURE:
    • 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.  
  • TRAINING:

Trainer             : Head – Quality Assurance / Designee

Trainees           : QA/QC/Production/Packaging/Store/Microbiology/P&A

  • DISTRIBUTION:

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(S):

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  

  • REFERENCE(S):

In House

  • REVISION HISTORY:
Sr. No.Revision No.Change Control No.Details of RevisionReason(s) for Revision
0100———–New SOPNew SOP

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