SOP for Storage and Use of Reagents & Chemicals

Objective

To monitor the storage and use of reagents & chemicals in the quality control department.

Scope

This SOP applies to all chemical reagents and solutions used for analytical testing, such as acids, bases, solvents, volumetric and indicator solutions. This SOP does not apply to reference standards, sample solutions, or chemicals for general use, such as cleaning agents for the quality control Department at PharmaInfo Ltd.

Responsibility

Doing: Technical Assistant

Checking: QA/QC Executive/Manager

Accountability

Head of the Department

Procedure

Receipt of Reagents and Chemicals

• After receiving the material QC personnel will check the detailed information given on the Container label and enter the following details in the material control register maintained separately for Reagents, Solvent, and Indicator in the Q.C. Department to ensure the material is received from the approved vendor by referring the approved vendor list.

1. Material Receiving Date
2. Name of the Material
3. Total Quantity
4. Mfg. Date
5. Exp. Date
6. Material Code

• Upon receipt, examine the container of any new reagent or chemical for damage. Damaged materials are to be returned to the supplier or disposed of according to established procedures. Upon receiving a receiving date is assigned on each label.

Opening date of Reagents and Chemicals

• When a container is first opened, initial and record the date on the label.

Expiration of Reagents and Chemicals

• The expiration date after opening is assigned and written on each label.
• Use the supplier label recommendation and initial and record the date on the label.
• If not indicated on the original supplier label an expiration date of not more than five years from receipt is assigned to all reagents and chemicals when known to be very stable.
• Store the reagents & chemicals at the appropriate temperature & condition indicated on the container.
• Mention the shelf life of all reagents/chemicals for 2 years from the date of opening the container.

• Store poisonous chemicals separately taking all safety precautions as per their Material Safety Data Sheet. (M.S.D.S)

Example: A chemically and physically stable reagent or chemical is received in May 2022 without an expiration date, then it is assigned an expiration date of May 2027.

• Destroy the reagents/chemicals after the expiry date as per SOP.

Abbreviation

SOP: Standard Operating Procedure

EXP: Expiry

MSDS: Material Safety Data Sheet.

Revision History

Nil

ALSO READ: SOP for Preparation & Storage of Test Solution