Standard Operating Procedure for Installation and Qualification of FFS Machine
1) Purpose
The purpose of this SOP is to define the procedure for installing and qualifying a Form-Fill-Seal (FFS) machine to ensure it meets operational requirements and regulatory standards before use in pharmaceutical manufacturing.
2) Scope
This SOP applies to the installation and qualification of all new and relocated FFS machines within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Engineering Department
– Coordinate the installation and qualification process of the FFS machine.
– Ensure compliance with manufacturer specifications and regulatory requirements.
3.2 Quality Assurance (QA) Personnel
– Review and approve installation and qualification protocols.
– Verify that all qualification tests and acceptance criteria are met.
3.3 Production Personnel
– Provide input on operational requirements and user needs during qualification.
4) Procedure
4.1 Installation Qualification (IQ)
4.1.1 Verify and document that the FFS machine and its components are installed correctly as per manufacturer specifications.
4.1.2 Perform operational checks to ensure proper installation and functionality.
4.2 Operational Qualification (OQ)
4.2.1 Validate the operational parameters of the FFS machine (e.g., temperature, pressure, speed).
4.2.2 Conduct performance testing to verify that the machine operates within specified limits.
4.3 Performance Qualification (PQ)
4.3.1 Perform simulated production
4.3.2 Collect and analyze data to confirm that product quality attributes are met during production.
4.4 Qualification Report
4.4.1 Compile all qualification data, including protocols, test results, and deviations encountered.
4.4.2 Prepare a qualification report summarizing findings and conclusions for QA review and approval.
5) Abbreviations, if any
– IQ: Installation Qualification
– OQ: Operational Qualification
– PQ: Performance Qualification
– QA: Quality Assurance
6) Documents, if any
– Installation Qualification Protocol
– Operational Qualification Protocol
– Performance Qualification Protocol
– Qualification Report
7) Reference, if any
– FDA Guidance for Industry: Process Validation: General Principles and Practices
– ICH Q9 Quality Risk Management
8) SOP Version
Version 1.0
