Handling of Fallen off / Damaged Status labels
Objective: To lay down a procedure for Handling of Fallen off / Damaged Status labels.
Scope
This Standard Operating Procedure is applicable for Handling Fallen-off / Damaged Status labels of Raw Material /Packing material at the formulation plant.
Responsibility
Concerned Department personnel shall be responsible for following the procedure mentioned in this SOP.
The concerned Department in charge, QC, and QA shall be responsible for the implementation of the procedure mentioned in this SOP.
Accountability
The concerned Department in charge & QA Head shall be accountable for implementation of this SOP.
Abbreviations and Definitions
Initiator Department: The Department that shall initiate the preparation or revision of SOP.
SOP: Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
QA: Quality Assurance
QC: Quality Control
GMP: Good Manufacturing Practices
Procedure
Status Label on Raw Material Containers
In case a status label of any Raw Material container has fallen off or has been damaged/defaced/torn and is not Readable, then the following procedure shall be adopted to re-label the container.
The Raw Material Store Charge shall inform the Quality Control Department with intimation to the Quality Assurance Department.
The Quality Control Analyst shall pay a visit to the Raw Material Store and shall inspect the relevant container and the fallen off / damaged/defaced / torn status label and shall compare the particulars given on the status label with the manufacturer’s label on the container and the previous laboratory record of testing the sample of that Raw Material.
The Quality Control Analyst shall also draw a sample of that material for confirmation.
If the result of retesting of the Raw Material tallies with the particulars given on the fallen-off / damaged status label and with the manufacturer’s label, then the fallen-off label shall be pasted on the container by the Quality Analyst. In case of the damaged/defaced/torn label, the Analyst shall prepare a duplicate copy of the status Label and paste it on the container. The old damaged label shall be destroyed in the presence of the Analyst, Quality Assurance person, and in charge of the Raw Material Store.
If the result of re-testing of the Raw Material matches with the previous record of the laboratory and the label of the manufacturer on the container but does not tally with the fallen-off label, then a duplicate status label shall be prepared and pasted on the container by the Analyst. The fallen-off label shall be destroyed in the presence of the Analyst, Quality Assurance person, and store Charge.
Status Labels on Packing Material Boxes :
In case of a status label of the box of any Packing Material has fallen off or has been damaged/defaced/torn and is not readable, then the following procedure shall be adopted to re-label the container:
The packing material store In-charge shall inform the Quality Control Department.
The Quality Control Analyst shall pay a visit to the Packing Material Store and shall inspect the relevant box and the fallen off / damaged/defaced / torn status label and shall compare the particulars given on the status label with the testing record of his department.
The Quality Control Analyst shall also take a sample of that Packing Material for confirmation.
If the result of re-testing of the Packing Material tallies with the particulars given on the fallen-off / damaged status label, then the fallen-off label shall be pasted on the box by the Quality Control Analyst. In case of a damaged/defaced/torn label, the Quality Control Analyst shall prepare a duplicate copy of the status label and paste it on the box. The old damaged label shall be destroyed in the presence of Quality Assurance and In-charge Packing Material Store.
If the result of re-testing of the Packing Material matches with a previous record of the Quality Control Analyst but does not tally with the fallen-off label, then a duplicate status label shall be prepared and Pasted on the box by the Quality Control Analyst and the fallen-off label shall be destroyed in the presence of Quality Assurance and Packing Material Store In-charge.
Status Labels Used store Department :
In case a status label attached to any Machine / Equipment has fallen off or has been damaged/defaced/torn and is not readable, then the following procedure shall be adopted to re-label the Machine / Equipment.
The Store personnel shall inform the Quality Assurance department.
The Quality Assurance shall pay a visit to the store department and shall examine the fallen off / damaged/defaced/torn status label and shall physically inspect the relevant Machine / Equipment.
If the fallen-off status label tallies with the process stage/status of the Machine / Equipment, then the fallen status label shall be attached to the Machine/equipment but if it does not match then it shall be destroyed in the presence of Quality Assurance and Store personnel and a fresh status label shall be prepared and shall be attached to the Machine / Equipment by Store personnel.
In case of a damaged / defaced / torn status label, a fresh status label shall be prepared and shall be attached to the Machine / Equipment by Store personnel and the damaged label shall be destroyed in the presence of Quality Assurance and Store personnel.
Forms and Records (Annexures)
Intimation about Fallen off / Damaged Status Label – Annexure-I
Distribution
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production, Quality Control and Stores
