Standard Operating Procedure for Validation of FFS Machine Process

1) Purpose

The purpose of this SOP is to establish a procedure for validating the Form-Fill-Seal (FFS) machine process to ensure consistent and reliable packaging of pharmaceutical products.

2) Scope

This SOP applies to the validation of all FFS machines used in the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Production Manager
– Initiate and oversee the validation process of FFS machines.
– Ensure compliance with validation protocols and regulatory requirements.
3.2 Quality Assurance (QA) Personnel
– Review and approve validation protocols and reports.
– Monitor the validation process to ensure adherence to SOPs.
3.3 Engineering Department
– Provide technical support and maintenance for FFS machines during validation.

4) Procedure

4.1 Protocol Development
4.1.1 Develop a validation protocol outlining the objectives, acceptance criteria, and testing methods for FFS machine validation.
4.1.2 Obtain approval of the protocol from QA and relevant stakeholders before initiation.
4.2 Installation Qualification (IQ)
4.2.1 Verify and document that the FFS machine and its components are installed correctly as per manufacturer specifications.
4.2.2 Perform operational checks to ensure proper installation and functionality.
4.3 Operational Qualification (OQ)
4.3.1 Validate the operational parameters of the FFS machine (e.g., temperature, pressure, speed).
4.3.2 Conduct