Disposal of in-process & rejected products

Disposal of in-process & rejected products

OBJECTIVE:

To lay down a procedure to describe the steps to be followed for disposal of in-process samples & rejected products during manufacturing.

SCOPE:

This SOP covers the disposal of in-process samples / rejected products, manufactured..

RESPONSIBILITY:

IPQA and Production personnel shall be responsible to follow the procedure mentioned in this SOP.

ACCOUNTABILITY:

Production Head & QA Head shall be accountable for compliance of the procedure mentioned in this SOP.

ATTACHMENTS:

 In – process product rejection and destruction note    – Attachment – I

PROCEDURE:

Storage the products or samples to be discarded in plastic containers with polybags in IPQA room, capsule filling room, sachet filling room/dry syrup room and compression rooms. The products, rejected during manufacturing processes shall be kept in designated place.

For in-process samples, label the container as “In-process materials – To be Destroyed” and for rejected products which are under manufacturing processes, label as “Reject”.

Rejected blisters, collected in secondary packaging area into the labeled containers “In-process materials – To be Destroyed” shall be destroyed. Before destruction, defoil the rejected blisters.

Rejected secondary and tertiary packing material, collected in secondary packaging area into the labeled containers “In-process materials – To be Destroyed” shall be destroyed. Before destruction, de-foil the rejected secondary and tertiary packing material.

Keep all these in – process samples or rejected products in specified containers with appropriate labels.

At the end of shift and after completion of manufacturing & packaging process, production personnel transfer the discarded in-process samples to ETP for disposal through scrap pass box.

Rejected products also shall be transferred to ETP for disposal through scrap pass box.

If the batch fails to comply with the approved specification at any process stage, it should be investigated. After confirmation of batch failure, the batch shall be transferred to scrap with “Reject” label for disposal.

Concerned department personnel should fill in-process product rejection and destruction note  and attach the investigation report and then get the approval from Production Head, QC Head and then QA Head.

REFERENCES:

  • In House

ABBREVIATIONS:

  • QA: Quality Assurance
  • SOP: Standard Operating Procedure
  • IPQA: In-process Quality Assurance

DISTRIBUTION LIST:

  • Quality Assurance
  • Quality Control
  • Production
  • Engineering
  • Warehouse

HISTORY OF REVISION:

Version  No.Effective DateReason for Revision
00New SOP