SOP of Handling of Raw & Packaging Materials under Re-Test due
Objective:To lay down a procedure for Handling of Raw & Packaging Materials under Re-Test due.
Scope:This SOP is applicable to all raw & packaging materials under retest due in warehouse at (Pharmaceutical Company Name).
Responsibility:
Concerned Store personnel shall be responsible for intimating Quality control about the retest due.
Quality control personnel shall be responsible for analysis and approval / rejection of material under retest due.
Accountability:
Head of Concerned Department & QA shall be accountable for the implementation of this SOP.
Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
Procedure:
The Warehouse personnel shall check the materials under re-test dates given by QC on the GRN & record the Re-Test in Re-Test Material Verification Record, Annexure – I.
The warehouse personnel shall raise the Re-Test request of Raw & Packaging Material with existing stock along with the actual receipt quantity & GRN No. to QC for sampling the material(s).
The container(s) / pack(s) of the material shall be transferred to the respective Quarantine area affixed with “QUARANTINE” label duly filled with current available quantity for re- test & signed by warehouse personnel.
The previous Quarantine label along with Approved status label shall be defaced with permanent black marker pen & new Quarantine label shall be affixed nearby defaced label.
The material to be retested in the next month shall be verified with existing stock recorded from the Material Stock Card.
The Intimation / Communication for retest shall be prepared by warehouse personnel through Re-Test Request of Raw & Packaging Material refer Annexure-II. The Re-Test Request shall be send to QC on the Re-Test date mentioned in the GRN.
The QC personnel take the sample of the respective material & after final analysis, the “APPROVED” / “REJECTED” label as applicable shall be displayed on the container(s) / Pack(s) of the material.
Approved / Rejected status of materials shall be provided by Quality Control through Re-Test Request of Raw & Packaging Material Annexure-II along with respective label.
Warehouse personnel shall transfer the material(s) in their respective storage area as per status provided by QC.
Note: – The materials under Re-Test date (To be used within seven days) provided by QC shall only be tested at the time of requirement / production plan & not to tested time & again if Re-evaluation date of that material already passed.
For More Pharma Updates Visit –https://pharmaguidances.com
