Standard Operating Procedure for Sample Collection during Form-Fill-Seal (FFS) Operations

1) Purpose

The purpose of this SOP is to define procedures for collecting representative samples during Form-Fill-Seal (FFS) operations to ensure product quality and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the collection and testing of samples during FFS operations within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Production Operators

• Collect representative samples as per sampling plan.
• Handle samples appropriately to prevent contamination.

3.2 Quality Control (QC) Analysts

• Perform testing and analysis of collected samples.
• Document and report sample test results.

4) Procedure

4.1 Sample Collection

1. Follow sampling plan to identify sampling points and frequencies.
2. Use sanitized sampling tools and containers for sample collection.

4.2 Handling and Transportation

1. Label each sample container with unique identifiers.
2. Transport samples to QC laboratory under controlled conditions.

4.3 Testing and Analysis

1. Perform analytical tests according to approved test methods.
2. Record and interpret test results accurately.

4.4 Disposal of Samples

1. Dispose of samples according to waste disposal procedures.
2. Document sample disposal in compliance with environmental regulations.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QC: Quality Control; FFS: Form-Fill-Seal

6) Documents, if any

• Sampling Plan
• Sample Collection Log
• Test Results and Analysis Reports

7) Reference, if any

USP General Chapter <1116>: Microbiological Control and Monitoring of Aseptic Processing Environments
ICH Q2(R1): Validation of Analytical