1. Purpose of Preparation and Handling of Working Standards
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for the preparation, handling, and usage of working standards in [Company Name]. This SOP for ensures that working standards are accurately prepared, properly handled, and consistently used to support quality control, calibration, and testing activities.
2. Scope of Preparation and Handling of Working Standards
This SOP applies to all laboratory personnel responsible for the preparation, handling, and usage of working standards in [Company Name]. It encompasses the preparation of working standards, their labeling, storage, and proper usage.
3. Definitions involved in Preparation and Handling of Working Standards
3.1 Working Standard:
A reference material used for calibrating instruments, validating analytical methods, and ensuring the accuracy of test results.
3.2 Analytical Balance:
A precision instrument used to measure the mass of substances.
3.3 Certified Reference Material (CRM):
A reference material characterized by a metrologically valid procedure for one or more specified properties.
4. Responsibilities in Preparation and Handling of Working Standards
4.1. Laboratory Manager
4.1.1 Oversee and ensure compliance with this SOP.
4.1.2 Allocate resources and personnel for the preparation and handling of working standards.
4.2. Laboratory Analysts
4.2.1 Prepare working standards following the procedures outlined in this SOP.
4.2.2 Maintain accurate records of working standard preparation and usage.
4.3. Quality Control Manager
4.3.1 Verify the accuracy and traceability of working standards.
4.3.2 Monitor and audit compliance with this SOP.
5. Working Standard Preparation
5.1. Selection of Reference Material
5.1.1 Select a certified reference material (CRM) or a suitable reference substance as the basis for the working standard.
5.1.2 Verify the traceability and certificate of analysis of the reference material.
5.2. Preparation Procedures
5.2.1 Weigh the reference material using a calibrated analytical balance.
5.2.2 Prepare the working standard by dissolving or diluting the reference material in an appropriate solvent or matrix.
5.2.3 Mix and homogenize the solution thoroughly.
5.3. Labeling
5.3.1 Label the working standard container with the following information:
- Name and identification of the substance.
- Date of preparation.
- Concentration or purity.
- Preparer’s initials or signature.
6. Handling and Storage
6.1. Handling
6.1.1 Handle working standards with care to prevent contamination or evaporation.
6.1.2 Use clean, dry, and calibrated glassware and equipment for handling and dispensing.
6.2. Storage
6.2.1 Store working standards in appropriate containers and conditions, protected from light, moisture, and temperature extremes.
6.2.2 Assign a designated storage area with controlled access.
7. Usage of Working Standards
7.1. Calibration and Analysis
7.1.1 Use working standards for instrument calibration and analytical procedures as required.
7.1.2 Follow documented procedures for the correct usage of working standards.
8. Record Keeping
8.1. Records
8.1.1 Maintain accurate records of working standard preparation, usage, and any deviations.
8.1.2 Record details such as dates, preparer’s name, lot numbers, concentrations, and usage information.
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