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SOP for Handling and Storage of Control Samples

OBJECTIVE
To lay down a procedure for handling and storage of control samples.

SCOPE
This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY
Execution : Chemist and above – QC department.
Checking : Asst. Manager and above – QC department

PROCEDURE
  • Control samples are collected at random during the packaging operation of every batch of each product.
  • The number of samples collected shall be entered in the register.
  • Samples shall be stored at 30°C ± 2°C, otherwise any specific condition mention on the sample label.
  • Control samples shall be retained up to one year after expiry date.

REFERENCE(s)
Nil.

ABBREVIATION(s)
SOP : Standard Operating Procedure
Q.C Quality control
°C Degree centigrade

ANNEXURE(s)
Annexure No. – 1 - Control sample register

 
REVISION CARD
Nil

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