Standard Operating Procedure for Quality Control Sample Management

1) Purpose

This SOP outlines the procedures for the proper management of quality control samples, including their collection, handling, storage, and disposal, to ensure the integrity and reliability of test results.

2) Scope

This SOP applies to all quality control samples collected, tested, and managed within the company’s Quality Control (QC) laboratory.

3) Responsibilities

The Quality Control (QC) department is responsible for implementing and maintaining this SOP. All personnel involved in sample collection, handling, and testing must adhere to the procedures outlined herein.

4) Procedure

4.1 Sample Collection

1. Identify the type and quantity of samples needed according to the testing plan or protocol.
2. Collect samples using appropriate and clean sampling tools to avoid contamination.
3. Label each sample container with the necessary information, including the sample ID, batch number, date, and time of collection.

4.2 Sample Handling

1. Transport samples to the QC laboratory promptly to prevent degradation or contamination.
2. Handle samples with care to maintain their integrity, following standard safety and handling procedures.
3. Log the receipt of samples in the sample management system.

4.3 Sample Storage

1. Store samples in designated areas under appropriate conditions (e.g., temperature, humidity) to ensure their stability.
2. Maintain a sample storage log to track the location and status of each sample.
3. Regularly monitor storage conditions and document any deviations.

4.4 Sample Testing

1. Schedule and prioritize samples for testing according to the testing plan and urgency.
2. Perform tests as per the standard operating procedures (SOPs) and record all results accurately.
3. Ensure that all equipment used for testing is calibrated and maintained.

4.5 Sample Retention and Disposal

1. Retain samples for the required period as specified by regulatory guidelines and company policy.
2. After the retention period, dispose of samples according to the company’s waste disposal procedures.
3. Document the disposal of samples in the sample management system.

4.6 Documentation and Records

1. Maintain complete and accurate records of all sample-related activities, including collection, handling, storage, testing, retention, and disposal.
2. Ensure that all documentation is readily accessible for audits and reviews.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Sample Collection Logs, Sample Management System Records, Testing Plans, Test Result Records, Sample Storage Logs, Sample Disposal Records

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), and ICH Q10 (Pharmaceutical Quality System)

8) SOP Version

Version 1.0