Standard Operating Procedure for Retained Sample Management

1) Purpose

This SOP outlines the procedures for the handling, storage, retention, and disposal of retained samples to ensure traceability, integrity, and compliance with regulatory requirements in pharmaceutical manufacturing.

2) Scope

This SOP applies to all personnel involved in the collection, labeling, storage, retrieval, and disposal of retained samples within the pharmaceutical facility, including production, quality control, and quality assurance departments.

3) Responsibilities

The Quality Assurance Manager or designated personnel are responsible for overseeing retained sample management procedures. Production and Quality Control personnel are responsible for performing and documenting activities related to retained samples.

4) Procedure

4.1 Collection and Identification

1. Collect retained samples representative of each batch or lot of finished product, intermediates, or raw materials as per sampling procedures.
2. Label each retained sample container with batch/lot number, manufacturing date, expiration date, and storage conditions.

4.2 Storage Conditions

1. Store retained samples under appropriate conditions to maintain their integrity and stability throughout the retention period.
2. Monitor storage conditions regularly and record environmental monitoring data to ensure sample stability.

4.3 Retention Period

1. Establish and document retention periods for retained samples based on regulatory requirements, stability data, and company policies.
2. Extend retention periods as necessary based on ongoing stability studies or regulatory requests.

4.4 Sample Retrieval and Use

1. Retrieve retained samples for testing, investigation, or reference purposes as required by production, quality control, or regulatory authorities.
2. Document all retrieval activities including purpose, date, quantity used, and any additional testing conducted.

4.5 Disposal of Retained Samples

1. Dispose of retained samples following approved procedures and documented disposition activities, ensuring compliance with regulatory guidelines.
2. Maintain records of retained sample inventory, usage, and disposal in a controlled and traceable manner.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Retained Sample Inventory Records, Retention Schedule, Disposal Records

7) Reference, if any

Regulatory guidelines such as ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products, USP General Chapter 1160 Pharmaceutical Dosage Forms

8) SOP Version

Version 1.0