Standard Operating Procedure for In-process Monitoring and Control during FFS Operations

1) Purpose

The purpose of this SOP is to outline the procedures for monitoring and controlling critical parameters during Form-Fill-Seal (FFS) operations to ensure product quality and process efficiency.

2) Scope

This SOP applies to all FFS operations conducted within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Production Operators

• Monitor FFS machine operation and critical parameters as per defined procedures.
• Take corrective actions as necessary to maintain process control and product quality.

3.2 Quality Assurance (QA) Personnel

• Review in-process monitoring data and verify compliance with specifications.
• Investigate deviations and implement corrective and preventive actions (CAPA) as required.

4) Procedure

4.1 Setup and Preparation

1. Ensure FFS machine is set up and calibrated according to approved procedures.
2. Verify availability of raw materials and packaging components for the operation.

4.2 In-process Monitoring

1. Monitor critical process parameters such as temperature, pressure, and fill volume during FFS operations.
2. Record monitoring data at specified intervals or events as per batch records.

4.3 Control Measures

1. Take immediate corrective actions in case of deviations from specified limits or conditions.
2. Notify relevant personnel (e.g., supervisors, QA) and document actions taken.

4.4 Documentation and Reporting

1. Document in-process monitoring activities, including deviations and corrective actions.
2. Report any significant deviations or trends to QA and initiate investigation if necessary.

5) Abbreviations, if any

FFS: Form-Fill-Seal
QA: Quality Assurance
CAPA: Corrective and Preventive Action

6) Documents, if any

• In-process Monitoring Records
• Batch Records
• Deviation Reports

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Process Validation: General Principles and Practices

8) SOP Version

Version 1.0