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 applies 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 hand over 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 hand over 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/polybag in which the materials to be discarded are collected.

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• 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 hand over the container/poly bag to their Supervisor.
• The Supervisor shall collect the container/poly bag from individual operators and IPQC personnel and hand it over to the QC personnel for disposal of the same.

• The QC personnel shall receive the materials to be discarded from the Supervisor and weigh them.
• The QC personnel shall disperse the materials to be discarded in raw water and make the resulting mixture neutral using the 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

ALSO READ: SOP for Storage Procedure of In-Process Capsules