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.

ALSO READ: SOP for Collection and Storage of Retention Sample of Raw Material

• Samples shall be stored at 30°C ± 2°C, otherwise, any specific condition is mentioned on the sample label.
• Control samples shall be retained up to one year after the expiry date.

REFERENCE

Nil

ABBREVIATION

SOP: Standard Operating Procedure

QC: Quality control

°C: Degree centigrade

ANNEXURE

Annexure No. – 1 - Control sample register

REVISION HISTORY

Nil

ALSO READ: SOP for Receipt and Handling of Laboratory Samples