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.

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• 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 the expiry date.

REFERENCE

Nil.

ABBREVIATION

SOP : Standard Operating Procedure

Q.C : Quality control

°C : Degree centigrade

ANNEXURE

Annexure No. – 1 - Control sample register

 

REVISION HISTORY

Nil

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