HOT POST

50/recent/ticker-posts

Header Ads Widget

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 is applicable 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 Pharmasky 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 maintain separately for Reagents, Solvent and Indicator in Q.C. Department for ensuring 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

Post a Comment

0 Comments

close