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Rejection Handling Procedure (API/Drug Product)

Standard Operating Procedure (SOP) for Handling of Interim/On-line Rejection during manufacturing and packing of drug substances or drug product.

Handling of Interim/On-line Rejection

1.0   Purpose :

    • To define procedure for Handling of Interim/On-line Rejections during manufacturing and packing of drug substances.

2.0   Scope :

    • This SOP is applicable for Handling of Interim/On-line Rejections during manufacturing and packing of drug substances and intermediates at API Manufacturing

3.0   Reference, Attachments and Annexures :

    • References :
    • In House
    • Attachments :
    • Attachment-1: Interim/On-line Rejection Form
    • Attachment-2 : Label for “Under Hold”

4.0   Responsibility – Handling of Rejection:

    • Concerned Manufacturing Supervisor / Designee :

    • Identify and report the rejections found during manufacturing, packing and handling of material.
    • Segregate the rejected material and keep separate to avoid misuse/mix-up with other materials.
    • Raise the event & investigate in consultation with Department Head & Quality Assurance Head.
    • Handle the rejected material as per the procedure

    • QA Officer or Designee :

    • Ensure that rejected materials are properly segregated and kept separate to avoid misuse/mix-up with other materials.
    • Hold the further manufacturing or use of batch, if required, until the completion of investigation and to assure that there is no impact on product quality.
    • Help concerned Manufacturing Supervisor in investigation of abnormal rejections.
    • Ensure that rejected materials are properly handled and there is no impact on product quality.

    • Department Head or Designee :

    • Ensure the observation reported by concern supervisor and rejected materials are properly segregated, kept separate to avoid misuse/mix-up with other materials.
    • Co-ordinate concerned Manufacturing Supervisor in investigation of rejections.
    • Discuss and recommend the further course of action for the rejected material in consultation of QA Head, Quality Head and Factory Head.

    • QA head or Designee, Quality Head or Designee, Factory Head or Designee :

    • To recommend and approve further course of action for handling of the rejected material.

    • Warehouse Designee / ETP Designee / Purchase Designee :

    • To handle rejected material as per the procedure for handling of rejection.

5.0   Procedure for Handling of Rejection:

    • Interim/On-line rejection of Raw Materials (including Intermediate) for batch:

    • During manufacturing of the batch, if any of the issued / dispensed raw material including Intermediate, solvent found with abnormal observations (i.e. black/ foreign particles, abnormal odor/ appearance, description, color etc.),
    • Then concern manufacturing supervisor or designee shall immediately segregate the material and intimate to the Department Head & QA Head/Designee.
    • On abnormal observation in any Raw Material, Concerned manufacturing supervisor or designee shall paste a “Under Hold” label as mentioned in Attachment-2 on that container/material.
    • Concerned manufacturing supervisor or designee shall keep this material in the separate designated place.

    • Care shall be taken to avoid misuse/mix-up with other materials.

    • Concerned manufacturing supervisor or designee shall mention details of observation in the “Interim/On-line Rejection from” as given in the attachment-1.
    • Concerned manufacturing supervisor or designee shall intimate to Department head/ designee and QA Head/ designee who will inspect the material and will note the Observation in the “Interim/On-line Rejection Form”.
    • On observation if the rejection is confirmed, QA head/Designee shall sign on the “Under Hold” Label pasted on the container/material.
    • Based on type of rejection, QA head/Designee shall decide to extend the investigation to other material for such rejection if any.
    • If such observation found in any other material, the Event shall be raised and investigation shall be carried out as per the respective event investigation procedure.

    • QA designee shall affix the “Rejected” label near the “Under Hold” label.

    • Manufacturing supervisor or designee shall take the replacement material from warehouse and proceed for further manufacturing of the batch or operation.
    • If the material rejection is confirmed, concerned manufacturing Department Head Designee shall discuss with Quality Head and Factory head for further course of action.
    • If required event shall be raised and investigated, the event reference No. shall be given in the “Interim Rejection/on-line rejection form”.
    • The material shall be handled as per the recommended action like Reprocessing, Reworking, Further Processing, destruction, Return to ware house or any other.
    • If material is to be reprocess/ rework/ return to Ware House then manufacturing supervisor or designee shall return the “Under Hold” material to the warehouse.
    • Ware House designee shall make necessary entries in the system for the rejection of material, and shall keep in the separate designated rejection area.
    • If destruction of rejected material is to be carried out, warehouse shall transfer the rejected material to the ETP department along with “Interim/On-line Rejection Form”
    • In the ETP department, destruction of the rejected material shall be carried out as per appropriate procedure.
    • Purchase department / warehouse shall decide to inform to party/ vendor/ supplier for the return of rejected material or destruction of material at our end.
    • Original copy of the “Interim Rejection/on-line rejection from” shall be filed in QA and photo copy of the same shall be given to Warehouse, Accounts and Purchase department.

    • In-process rejection :

    • During manufacturing of the drug substances or Intermediate batch, if any abnormal observation (i.e. abnormal odor/ appearance, description, color foreign particles, excess addition of solvent or mixing of other raw material etc.) or other handling loss are noticed,
    • Then concerned manufacturing supervisor or designee shall immediately intimate to the Department Head/Designee & QA Head /Designee.
    • The event shall be raised and Investigated as per the respective procedure for event investigation and Interim/On-line Rejection form shall not be raised.

    • Interim/On-line rejection of Packing Material :

    • During packing of the batch, if any of the packing material found with abnormal observations (i.e. size/shape variation, dirty/contaminated packing material, integrity loss etc.), then concerned Supervisor or designee shall immediately segregate the material.
    • On abnormal observation in any Packing Material, Concerned manufacturing supervisor or designee shall paste a “Under Hold” label as mentioned in Attachment-2 on that container/material
    • Concerned manufacturing supervisor or designee shall keep this material in the separate designated place. Care shall be taken to avoid misuse/mix-up with other
    • Concerned manufacturing supervisor or designee shall mention the details of observation in the “Interim/On-line Rejection Form” as given in the attachment-1.
    • Concerned manufacturing supervisor or designee shall intimate to Department head/ designee and QA Head/ designee who will inspect the material and will note the Observation in the “Interim/On-line Rejection Form”.

    • QA designee shall affix the “Rejected” label near the “Under Hold” label.

    • Manufacturing supervisor or designee shall take the replacement material from warehouse and proceed for further process or operation.
    • If the material rejection is confirmed, concerned manufacturing Department Head / Designee shall discuss with Quality Head and Factory head for thither course of action.
    • The material shall handle as per the recommended action for Destruction or Return to ware house or any other.
    • If material return to Ware House then manufacturing supervisor or designee shall return the rejected material to the warehouse.
    • Ware House designee shall make necessary entries in the system for the rejection of material, and keep the material in the separate designated rejection area.
    • Purchase department / warehouse shall decide to inform to party/ vendor/ supplier for the return of rejected material.
    • Original copy of the “Interim/On-line Rejection Form” shall fill in QA and photo copy of the same shall  give to Warehouse, Accounts and Purchase department.

Attachment – 1

Interim / On-line Rejection Form

Department:                     

Product / Material Name
Type of Material (RM/In-process/Packing Material)
Quantity (Kg/Ltrs/No.)
A.R. No. / B. No.
Date of Manufacturing Expiry/Retest date :
Abnormality Observed By Date
Detail of observation/ abnormality :

Sign/Date:          

Verification and Comments By Department Head/Designee :

Sign/Date:          

Verification and Comments By QA Head /Designee :

Sign/Date:          

Verification of such observation in other material (If required) :
Reference Event-Investigation No. (If any):
Recommendation (do tick mark):
Reprocessing Reworking Further processing Destruction Return to the Ware House Any Other
Department Head Q A Head Quality Head Factory Head
Based on Recommendations material handed over to : Ware House / ETP / Production

Material Received By (Date/ Sign):                     

Name of Department :                                     
Detail of Action taken as per the Recommendation :
Recommended Action taken by (Sign/Date) : Verified By Quality Assurance (Sign/Date) :

Attachment – 2

UNDER HOLD

Name of Material : ___________________________

Item Code : __________________________________

A.R. No. : ____________________________________

Batch No. : ___________________________________

Brief Reason for Hold : _______________________

Hold By                                     Checked By

Sign :                                         Sign :

Date :                                         Date :

*******************************************END*******************************************

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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