Additional Materials Return procedure, Purpose:
Additional Materials Return procedure, To lay down the procedure for return of Additional Part of Raw (Excipient) and Primary Packaging materials to Ware-House.
Additional Materials Return procedure, Scope:
This SOP is applicable for the Production Area of the XX Pharmaceuticals Limited.
Definition / Abbreviation:
[][]N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows :
Operator
[][]To follow the laid down procedure.
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly.
Manager, Quality Assurance
[][]To approve the Document.
Procedure:
Precaution:
[][]Ensure weighing and counting of the materials is correct.
[][]Returning of Unused Raw Materials (Excipient)
[][]After dispensing unused Raw Material (Excipient) can return to store.
[][]Enter all the details like Product Name, Batch No., Batch size, Name of the material, Quantity to be returned, Material ID No., Lab. Control No. on the ‘Stock Return Note’ (Annexure – I).
[][]Operator shall mention all details in Stock Return Note (SRN) and Executive, Production shall check all of them accordingly.
[][]The SRN shall have triplicate copy. All the copies shall be moved along with the physical stock to the Ware-House and Executive / In-charge, Ware-House shall return the rest 02 (Two) copies to the Packaging after duly signed. One copy shall attach with Batch Manufacturing Record and third copy shall retain in the book as reference copy.
[][]Returning of Unused Primary Packaging Materials
[][]After dispensing unused Primary Packaging Material can return to store.
[][]Individual rolls of Aluminum foil, PVDC and Alu bottom film which is return shall weigh and glass bottle, stopper and Alu cap shall count.
[][]Enter all the details like Product Name, Batch No., Batch size, Name of the material, Quantity to be returned, Material ID No., Lab. Control No. on the ‘Stock Return Note’ (Annexure – I).
[][]Operator shall mention all details in Stock Return Note (SRN) and Executive, Production shall check all of them accordingly.
[][]The SRN shall have triplicate copy. All the copies shall be moved along with the physical stock to the Ware-House and Executive / In-charge, Ware-House shall return the rest 02 (Two) copies to the Packaging after duly signed. One copy shall attach with Batch Manufacturing Record and another copy shall retain in the book as reference copy.
Returning of Raw Materials (Excipient) / Primary Packaging Materials Rejecting Online
[][]When the raw materials (excipient) / primary packaging materials are observe to be defective on-line such as having lumps or foreign materials in case of raw materials (excipient) and sealing problem or pinholes in case of foils keep aside the material.
[][]On line rejected material shall return to warehouse as per handling of on line rejection guideline of QA.
Annexure:
Annexure I – Stock Return Note.