Protocol for Plasma Handling and Processing in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the proper handling, processing, and storage of plasma samples collected from study participants in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the receipt, processing, and storage of plasma samples, including Clinical Research Associates (CRAs), Laboratory Technicians, and Data Managers.

Responsibilities

• The Study Coordinator is responsible for coordinating plasma sample collection activities and ensuring compliance with the study protocol and regulatory requirements.
• The Laboratory Technician or designated personnel are responsible for processing plasma samples according to established procedures and safety guidelines.
• The Data Manager is responsible for maintaining accurate records of plasma sample receipt, processing, and storage, and ensuring data integrity throughout the process.

Procedure

1. Receive plasma samples from the study site or designated collection site, ensuring proper packaging, labeling, and documentation.
2. Inspect plasma samples upon receipt for any signs of damage, leakage, or contamination, and record any discrepancies or deviations.
3. Centrifuge plasma samples immediately after receipt to separate plasma from cells or other components, following established centrifugation protocols.
4. Aliquot plasma samples into labeled tubes or containers using sterile techniques and appropriate pipetting equipment.
5. Record sample aliquoting details, including volume, date, and time of aliquoting, and any relevant identifiers or annotations.
6. Store aliquoted plasma samples at the appropriate temperature and conditions specified in the study protocol or standard operating procedures.
7. Maintain accurate and up-to-date inventory records of plasma samples, including location, quantity, and expiration dates.
8. Dispose of unused or expired plasma samples according to established protocols and regulatory requirements.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate

Documents

• Plasma Sample Receipt Log
• Plasma Processing Records
• Plasma Sample Inventory
• Disposal Documentation

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory requirements for sample handling and processing.

SOP Version

Version 1.0