Department | Warehouse | Document no | WAR-095 | ||
Title | Status Labels | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
Purpose
The purpose of this standard operating procedure is to define the meaning of the status labels used at GMP sites.
Scope
This procedure applies to status labels applied to all inventory stored in pharmaceuticals warehouses and used throughout the manufacturing process. This includes but is not limited to raw materials, packaging, consumables, purchased product, contract manufactured product and finished products.
Responsibilities
Quality Assurance:
– Ensure compliance with the requirements of this standard operating procedure.
– Application of Approved, Approved with Restrictions, Released, Rejected, Hold, Approved for Processing, Retention, and Release for Supply labels
– Training of appropriate staff approved to apply Approved, Approved with Restrictions, Rejected, Hold and Release for Supply labels.
– QA personnel only may apply Released, Approved for Further Processing and Retention labels as these labels are applied using a meto gun and the number of labels issued cannot be controlled.
Ensure secure storage of all status labels except Inspection and Direct Putaway labels.
Warehouse:
– Ensure all site manufactured semi finished and finished goods inventory which are receipted into stores have a pallet card (refer to Appendix 1) attached to each pallet.
– Ensure all inventory which are receipted into stores have a status label applied (under inspection, direct putaway)
– Ensure application of status labels other than Inspection and Direct Putaway, is only performed by staff trained by QA personnel.
– Ensure secure storage of status labels.
Manufacturing:
– Ensure all semi finished or finished goods have a Pallet Card (refer to Appendix 1) attached prior to sending to stores.
Procedure
1.1 Direct Putaway Label
DIRECT PUTAWAY | What this label means: | |
THIS MATERIAL MAY BE USED IN MANUFACTURING | ||
Ø This label is applied by warehouse personnel to incoming goods booked directly into (approved for use or released for supply) in the ERP system. | ||
Ø These labels are automatically generated by the ERP system. | ||
Ø These goods do not require inspection and disposition by QA. | ||
1.2 Inspection Label
INSPECTION | What this label means: | |
THIS MATERIAL CAN NOT BE USED IN MANUFACTURING or DISTRIBUTED IN SUPPLY CHAIN | ||
Ø This label is applied by warehouse personnel to incoming goods booked in ERP system in (Quarantine) – Purchase Order Receive Goods Ø These labels are automatically generated by the ERP system. Ø Manufactured goods booked into Quarantine in the ERP system – Manufacture Order Report Receipt have an ‘Under Inspection’ pallet card (refer Appendix 1) attached by manufacturing. | ||
Ø These goods require inspection and disposition by QA to be changed to approved for use or released for supply or rejected and not suitable for use in manufacturing or sale. | ||
1.3 Approved Label
APPROVED | What this label means: | |
THIS MATERIAL MAY BE USED IN MANUFACTURING Or THIS PURCHASED MATERIAL IS RELEASED FOR SUPPLY TO CUSTOMERS | ||
Ø This label is applied by QA personnel (or trained warehouse personnel) after disposition (approved for use or released for supply) in the ERP system. | ||
Ø These labels are automatically generated by the ERP system. | ||
Ø These labels may also be generated using the labelview program for material that has been re-evaluated and dispositioned in the ERP system. | ||
1.4 Approved with Restrictions Label
APPROVED WITH RESTRICTIONS | What this label means: |
THIS MATERIAL MAY BE USED IN MANUFACTURING but RESTRICTIONS APPLY | |
Ø This label is applied by QA personnel (or trained warehouse personnel) on completion of a risk assessment identifying restrictions to be applied to the use of the material. Ø The material is disposition (approved for use or released for supply) in the ERP system. | |
Ø This label lists the restrictions that apply to the use of the material | |
Ø These labels are generated using the labelview program | |
1.5 Released Label (Gun)
RELEASED | What this label means: | |
THIS MATERIAL MAY BE USED IN MANUFACTURING | ||
Ø This label may be applied by QA personnel after disposition of relevant materials as required Ø This label is applied to inner core of label rolls. | ||
Ø These labels come pre printed on a roll for application with a meto gun | ||
1.6 Approved for Further Processing Label (Gun)
APPROVED FOR PROCESSING | What this label means: | |
QA HAS GRANTED APPROVAL FOR RESTRICTED USE OF THIS MATERIAL | ||
Ø This label is applied by QA personnel after assessment of a request from manufacturing to use material not yet dispositioned (managed as a planned deviation – refer QMS-035 Pharmaceutical Deviation Report System) | ||
Ø Warehouse is responsible for placing an Inspection label over the Approved for Processing label when restricted use is complete and unused material is returned to warehouse | ||
Ø These labels come pre printed on a roll for application with a metro gun | ||
1.7 Release for Supply Label
RELEASE FOR SUPPLY | What this label means: | |
THIS MANUFACTURED MATERIAL IS RELEASED FOR SUPPLY TO CUSTOMERS | ||
Ø This label is applied by QA personnel (or trained warehouse personnel) after disposition (approved for use or released for supply) in the ERP system. | ||
Ø These labels are automatically generated by the ERP system | ||
Ø Goods can not be picked for dispatch to customer without Release for Supply labels applied | ||
1.8 Rejected Label
REJECTED | What this label means: | |
THIS MATERIAL IS NOT ACCEPTABLE FOR USE IN MANUFACTURING or DISTRIBUTION IN SUPPLY CHAIN and is awaiting RETURN TO SUPPLIER or DISPOSAL GOODS MUST REMAIN IN A QUARANTINE LOCATION IN THE WAREHOUSE | ||
Ø This label is applied by QA personnel (or trained warehouse personnel) after disposition as (rejected and not suitable for use in manufacturing or sale) in the ERP system. | ||
Ø These labels are automatically generated by the ERP system | ||
Ø These labels may also be generated using the labelview program for material that has been re-evaluated and dispositioned as (rejected and not suitable for use in manufacturing or sale) in the ERP system. | ||
1.9 Hold
HOLD | What this label means: |
THIS MATERIAL IS ON HOLD AND MAY NOT BE USED or DISCARDED UNTIL DISPOSITION STATUS IS DETERMINED BY QA. | |
Ø This label is used to replace an Approved / Release for Supply / Approved for further processing label and is applied by QA personnel (or trained warehouse personnel). It is used where inventory already dispositioned as (approved for use or released for supply) in the ERP system has been deemed as not suitable for use or release (e.g. deviation, non compliance with specifications or GMP process). There may be a status change in the ERP system. | |
Ø These labels are generated using the labelview program | |
1.10 Retention Label
RETENTION | What this label means: | |
THESE SAMPLES HAVE BEEN RETAINED BY QA AS RETENTION SAMPLES FOR THE PURPOSE OF FURTHER INVESTIGATION IN THE EVENT OF A CUSTOMER COMPLAINT | ||
Ø This label is applied by QA personnel after disposition of Imported finished Products, Packaging, Components and Raw Materials in the ERP system. | ||
Ø These labels come pre printed on a roll for application with a meto gun | ||
Ø These labels are not applied to Pharmaceutical Finished Products, Biological Finished Product, Antigens or Registered Labels. These materials have in house printed with the exception of Registered Labels which are attached to disposition documentation. | ||
APPENDIX 1 : Under Inspection Label