Standard Operating Procedure (SOP) for the Acquisition, Application, and Storage of Primary Standards

1.0 Purpose:
1.1 The purpose of this SOP is to establish a systematic procedure for the Acquisition, Application, and Storage of Primary Standards within the Quality Control (QC) Department of a pharmaceutical company.

2.0 Applicability:
2.1 This SOP applies to all primary standards used within the Quality Control Department OF XYZ company

3.0 Responsibilities:
3.1 The QC Officer or higher-level personnel are responsible for procuring, utilizing, and storing primary standards.
3.2 The Section In-Charge is accountable for implementing this SOP.
3.3 The QC Head or an assigned delegate is responsible for ensuring overall compliance with this SOP.

4.0 Procedure:

4.1 Primary Standard Definition:
4.1.1 A primary standard is a substance of high purity, which serves as a reference material for calibration, standardization of volumetric solutions, and other analytical procedures. It must meet stringent quality criteria and is accepted as a standard without requiring comparison to another substance.

4.2 Procurement Process:
4.2.1 The QC Officer/Executive must identify the primary standards required for calibration, standardization, and other analytical needs.
4.2.2 A list of necessary primary standards should be provided to the Section Head for procurement.
4.2.3 The Section Head must prepare an indent for the procurement, specifying the name, grade, manufacturer, and required quantity.
4.2.4 The primary standards procured must be of certified Analytical Reagent (AR) grade.

4.3 Receiving and Verification:
4.3.1 Upon receipt, the QC Officer/Executive must verify that each primary standard is properly labeled with the chemical name, purity, and grade.
4.3.2 The container’s seal should be inspected for integrity; any damaged or leaking containers must be returned.
4.3.3 If the container is intact, it can be utilized as a primary standard.

4.4 Storage Conditions:
4.4.1 Store primary standards at the temperature specified on the container’s label.
4.4.2 Record the date of opening on the container. The expiration date should be set as 3 years for solids, 2 years for liquids, and 6 months for hygroscopic materials.
4.4.3 Obtain and store the Certificate of Analysis (COA) for each primary standard.

4.5 Identification and Labeling:
4.5.1 Document all primary standards in Annexure I use a unique identification number format:

• PS-XXX (Where PS denotes Primary Standard, and XXX is the unique ID number).
• Label the primary standard containers with the ID number in the following format:
• PS-XXX-ZZ (Where ZZ is the container number for the same primary standard).
• Example: PS-001-01 for the first container, PS-001-02 for the second container, and so on.

4.6 Usage and Consumption:
4.6.1  Take the required quantity of the primary standard from the container, and do not return any excess to the original container.
4.6.2 Record the primary standard’s consumption in Annexure II.

4.7 Disposal:
4.7.1 Dispose of expired primary standards according to respective sop for the disposal of residual samples/leftover materials.

5.0 Precautions:
5.1 Allow primary standards stored below 25°C to reach room temperature before use.
5.2 Never introduce external tools directly into the container; if necessary, use clean butter paper.
5.3 Always wear appropriate Personal protective equipment during the handling of primary standards.

6.0 References:

• Follow GMP Guidelines, Indian Pharmacopoeia (IP), and British Pharmacopoeia (BP).

7.0 Annexures/Attachments:

• Annexure I: List of Primary Standards
• Annexure II: Consumption Record of Primary Standards

8.0 Abbreviations:

• LR: Laboratory Reagent
• A.R: Analytical Reagent
• G.R: General Reagent