STANDARD OPERATING PROCEDURE
Title : Procedure For the handling of rejected material Department: Quality Assurance
OBJECTIVE
- To lay down a procedure for defining the handling of rejected material.
SCOPE
- This procedure is applicable for segregation the rejected material such as primary and secondary packaging material, raw material, and any type of finished product.
RESPONSIBILITY
- Manager-Quality Control
- Manager-Production
- Manager-Warehouse
ACCOUNTABILITY
- Manager Quality Assurance
- VP-Plant & Operations.
PROCEDURE
Rejected material may comprises of
- Starting material (Raw materials and Packaging materials)
- Work in process.
- Finished Goods.
Disposal procedure for Finished Goods
The rejection if resulted due to the non – conformance with specifications, refer the subject to NCMRC to the notice of Manager-Quality Control/ Quality assurance.
In-case of decision for dispose, follow the procedure for destruction
In case of Market returned Finished Goods, proceed as per the SOP (Title: Handling of Returned Goods).
In such case a detailed Investigation report shall be made and documented to assess and justify the damage and to decide the course of action for Batch (s) dispatched to market.
Manager-QA to authorize the decision for destruction in both the above cases.
In Case of Market returned Finished Goods the central Excise personnel shall be contacted for the needful.
During destruction the bulk material i.e. Pharmaceutical dosage form shall be separated from the Primary packing material and destroyed by Chemical/ physical means.(Dissolve in water/ solvent etc.). The removed primary packing material along with secondary packing materials shall be destroyed by shredding, incineration as applicable.
The resulting slurry obtained by destruction of Pharmaceutical dosage form shall be treated as effluent.
Goods shall be destructed in presence of Personnel from Central excise, warehouse and Quality Assurance.
Record the destruction.
If the Finished Goods are rejected on the grounds of packaging alone, the Pharmaceutical dosage form may recover and repacked subjected to the approval of NCMRC.
Disposal procedure for Raw material
The rejection if resulted due to the non – conformance with specifications, refer the subject to NCMRC.
In such case a detailed Investigation shall be conducted and documented.
The rejection shall be intimated to purchase department. The decision shall be seeked to destroy the material at our end after obtaining permission from vendor or shall be send back to vendor through proper Documentation including Non returnable gate pass, COA & Invoice
For destruction of bulk Raw material at our end, suitable Chemical or Physical means shall be used in consultation with Manager –QC and Manager –QA.
Under no circumstances shall rejected raw material be used for processing.
Destruction activity shall be authorized by Manager – Quality Assurance.
Destruction shall be witnessed by designated person from Warehouse and Quality Assurance.
Document the destruction as per format.
Disposal of rejected packing material.
The rejection if resulted due to the non – conformance with specifications, refer the subject to NCMRC.
The rejection shall be intimated to purchase department. The decision shall be seeked to destroy the material at our end after obtaining permission from vendor or shall be send back to vendor through proper Documentation including Non returnable gate pass, COA & Invoice
The rejection of material will be intimated for purchase department and decide to destroy at our end after obtaining permission from vendor (In-case of printed packing materials) or shall be send back to vendor (only in-case of Non printed packing materials) through proper Documentation including Non returnable gate pass, COA & Invoice .
For Destruction of Printed/Non printed packing materials, shredding, crushing or incineration process shall be used as appropriate.
Under no circumstances shall rejected, packing materials be disposed by way of trade of dumping.
Destruction activity shall be authorized by Manager – Quality Assurance.
Destruction shall be witnessed by designated person from Warehouse and Quality Assurance.
Document the destruction as per format.
Disposal procedure for work in process
The rejection if resulted due to the non – conformance with specifications, refer the subject to NCMRC and proceed as per relative SOP.
If assessed as rejected the work in process material shall be destroyed by Chemical or physical (Incineration) means.
Under no circumstances shall rejected work in process be blended with other approved lots.
Manager- Quality Assurance, based on the investigation findings in each case shall prepare a detailed Report of probable cause together with proposed action to prevent reoccurrence of the rejection.
ABBREVIATIONS
- QA – Quality Assurance
- SOP – Standard Operating Procedure
- NCMRC – Non-Conformance Material review committee
- COA – Certificate of analysis
ATTACHMENTS:
| Sr. No. | Title | ATTACHMENTS |
| Material Destruction Note | ATTACHMENT-I |
DISTRIBUTION LIST
| Sr. No. | Copy No. | Department |
| 1 | Quality Assurance | |
| 2 | Quality Control | |
| 3 | Quality Control – Microbiology | |
| 4 | Production | |
| 5 | Engineering & Utility | |
| 6 | Personnel & Administration | |
| 7 | Warehouse |
ATTACHMENT-I
MATERIAL DESTRUCTION NOTE
Date: ______________
Material Detail …………………………………………………………
AR.No. ………………………………….. GRN No. ………………………………………………….
Supplier ……………………………… Party Name ………………………………………………
Stage of Rejection ………………………………………………………..
Destruction Quantity ……………………………………………………..
Reason for Rejection ……………………………………………………..
Mode of Destruction ……………………………………………………..
Destruction Initiated By
Officer-Store …………………………..
(Sign./ Date)
Justified By
In-charge – Store………………………
(Sign./ Date)
Reviewed By
Manager-QA ………………………
(Sign./ Date)
| Approved By
(VP-Plant & Operations) |
Done By
(Officer – Store) |
Witnessed By
(Officer – QA) |
|
| Name | |||
| Sign. with Date |
20
20
20