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 in a designated sample log or LIMS system.
2. Maintain accurate and up-to-date documentation including chain of custody records, testing schedules, and sample disposition.

4.5 Sample Retrieval and Disposal

1. Retrieve samples for testing according to testing schedules or requests.
2. Dispose of samples following approved procedures and regulatory guidelines, documenting disposal activities and reasons for disposal.

5) Abbreviations, if any

SOP: Standard Operating Procedure
COA: Certificate of Analysis
LIMS: Laboratory Information Management System

6) Documents, if any

Sample Receipt Records, Sample Storage Records, Chain of Custody Records, Sample Disposal Records

7) Reference, if any

Regulatory guidelines such as USP General Chapter 1070 Good Storage and Distribution Practices for Pharmaceutical Products, ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology, FDA Guidance for Industry: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0