Standard Operating Procedure for Laboratory Sample Management

1) Purpose

This SOP outlines the procedures for the handling, storage, tracking, and disposal of laboratory samples to ensure sample integrity, traceability, and compliance with regulatory requirements in pharmaceutical testing and analysis.

2) Scope

This SOP applies to all laboratory personnel involved in the receipt, handling, storage, testing, and disposal of samples within the pharmaceutical facility, including raw materials, intermediates, finished products, and stability samples.

3) Responsibilities

The Laboratory Manager or designated personnel are responsible for overseeing sample management procedures. Laboratory technicians are responsible for performing and documenting sample management activities.

4) Procedure

4.1 Sample Receipt and Handling

1. Receive samples in designated receiving areas and verify against accompanying documentation (COA, packing list).
2. Handle samples with care to avoid contamination, degradation, or cross-contamination during receipt and transfer.

4.2 Sample Storage Conditions

1. Store samples in designated storage areas according to specified conditions (temperature, humidity, light exposure).
2. Monitor storage conditions regularly and record environmental monitoring data to ensure sample stability.

4.3 Sample Identification and Labeling

1. Assign unique identifiers (barcode, sample ID) to each sample container or package.
2. Label samples clearly with necessary information including sample name, batch/lot number, storage conditions, and expiration date.

4.4 Sample Tracking and Documentation

1. Record sample receipt, storage, testing, and disposal activities