Home › Quality Control › SOP ›

SOP for Storage and Use of Reagents & Chemicals

Standard operating procedure to store and use of Reagents and Chemicals in Quality Control.
2024-04-17T12:14:56Z PrintOnline CoursesQuestion Forum 1 comment
✔ Technical Review by: | Last Verified:2024-04-17T12:14:56Z

1.0 OBJECTIVE

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

2.0 SCOPE

This procedure is applicable for all chemical and reagents received in quality control.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive/ Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Label all reagents/chemicals received with date of receipt and exp. date.
5.2 Mention shelf life of all reagents/chemicals for 5 years for sealed condition of container.
5.3 At the time of opening of bottle label all reagents/chemicals with the date of opening & use before.
5.4 Mention shelf life of all reagents/chemicals for 2 years from the date of opening the container
5.5 Record the above dates on a separate label affixed on the container in such a way that it does not obscure the manufacturer’s label.
5.6 Store the reagents & chemicals at appropriate temperature & condition indicated on the container.
5.7 Destroy the reagents/chemicals after expiry date as per SOP.
5.8 Store poisonous chemicals separately taking all safety precaution as per their Material Safety Data Sheet. (M.S.D.S)

6.0 ABBREVIATION

6.1 EXP = Expiry
6.2 MSDS = Material Safety Data Sheet.
Get ready to use editable SOPs in MS-Word FormatView List




is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

1 comment: Post Yours! Read Comment Policy ▼

  1. santosh bandari19 October

    How can we assign expiry date / shelf life for those manufacturer does not provided any. Is there any guideline on this assigning expiry dates in-house?

    ReplyDelete

Please don't spam. Comments having links would not be published.