SOPs

Handling of Fallen off / Damaged Status labels

ABHA

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 of Fallen off / Damaged Status labels of Raw Material /Packing material at formulation plant of Pharma Company.

Responsibility

  • Concerned Department personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Concerned Department in-charge, QC and QA shall be responsible for implementation of the procedure mentioned in this SOP.

Accountability

  • Concerned Department Incharge & QA Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions

  • Initiator Department   :           Department who 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 In-charge shall inform the Quality Control Department with intimation to Quality Assurance Department vide Annex-I.
  • 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 manufacturer’s label, then fallen off label shall be pasted on the container by Quality Analyst. In case of the damaged / defaced / torn label, the Analyst shall prepare a duplicate copy of status Label and shall paste on the container. The old damaged label shall be destroyed in the presence of Analyst, Quality Assurance person and In-charge 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 Analyst, Quality Assurance person and store In-charge.

Status Labels on Packing Material Boxes :

In case of a status label of 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 on Annex-I.
  • 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 status label with the testing record of his department.
  • The Quality Control Analyst shall also take sample of that Packing Material for confirmation.
  • If the result of re-testing of Packing Material tallies with the particulars given on the fallen off / damaged status label, then fallen off label shall be pasted on the box by Quality Control Analyst. In case of damaged / defaced / torn label, the Quality Control Analyst shall prepare a duplicate copy of the status label and shall paste 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 previous record of 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 with 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 intimate the Quality Assurance Department on Annex-I.
  • 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 fallen off 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 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

History: 

DateRevision Number         Reason for Revision
––                 New SOP

Annexure-I

Intimation about Fallen off / Damaged Status Label

From the Department of _________________________________ 

To the Department of ____________________________________

Sir,

It is for your information that the status label of the following Raw Material / Packing Material / Machine / Equipment has fallen off / has been damaged / defaced / torn and is not readable. You are requested to inspect the fallen off / damaged status label and take adequate steps for re-labeling the Material / Equipment. 

  Details of the Status label:-

________________________________________________________________________________

                                                                                                                                              Signature

 

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube