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SOP for Disposal of Tablets and Capsules after In-Process Checks

OBJECTIVE
To provide a procedure for disposal of excess tablets and capsules after In-process checks.

SCOPE
It is applicable to all the Non-recoverable residues (Machine start-up discards, oily powder, damaged EHG capsule shells etc.) and excess tablets / capsules after In-process checks from the Production department.

RESPONSIBILITY
  • Operator / IPQC personnel: To collect and handover the Non-recoverable residues and excess tablets / capsules after In-process checks as per this SOP.
  • QC personnel: To receive, discard and record the disposal of Non-recoverable residues and excess tablets / capsules as per this SOP.
  • Supervisor: To collect and handover all the Non-recoverable residues and excess tablets / capsules after In-process checks as per this SOP.
  • Production / QA Manager: To ensure that the procedure is followed.

PROCEDURE
  • The Operator and IPQC personnel shall collect all the Non-recoverable residues and excess tablets / capsules after In-process checks from their respective areas in a separate container / poly bag provided for the purpose.
  • Affix the label ‘To be discarded’ on the container / poly bag in which the materials to be discarded are collected.
  • After completion of the batch and properly accounting for the quantity of Non-recoverable residues and samples in the Batch record, the Operator and IPQC personnel shall handover the container / poly bag to their Supervisor.
  • The Supervisor shall collect the container / poly bag from individual operators and IPQC personnel and handover to the QC personnel for disposal of the same.
  • The QC personnel shall receive the materials to be discarded from the Supervisor and weight them.
  • The QC personnel shall disperse the materials to be discarded in raw water and make the resulting mixture neutral using suitable buffer. pH paper shall be used to check whether the mixture is neutral or not.
  • Finally, drain the resulting neutral mixture in a suitable drainage line.
  • The QC personnel shall maintain the record of Disposal activity Waste disposal Register.

ABBREVIATIONS
IPQC: In-process quality control
SOP: Standard operating procedure
QC: Quality control
QA: Quality assurance
EHG: Empty hard gelatin

REVISION HISTORY
Nil

 

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