Standard Operating Procedure for Validation of NDDS Process Control System
Purpose: To establish a comprehensive procedure for the validation of the NDDS Process Control System, ensuring compliance with regulatory standards and maintaining data integrity throughout the product lifecycle.
Scope: This SOP applies to the NDDS Process Control System utilized in the production area for controlling and recording NDDS Critical Process Parameters (CPPs). It encompasses all stages of validation including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Definitions:
- NDDS: Novel Drug Delivery Systems
- CPP: Critical Process Parameters
- CSV: Computer System Validation
- PLC: Programmable Logic Controller
- SCADA: Supervisory Control and Data Acquisition
Roles:
- Validation Team: Responsible for executing the validation protocol and documentation.
- Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
- Production Personnel: Operate the equipment and provide input during validation activities.
Lifecycle Procedure:
- Conduct User Requirements Specification (URS) development.
- Perform Design Qualification (DQ).
- Execute Installation Qualification (IQ).
- Carry out Operational Qualification (OQ).
- Complete Performance Qualification (PQ).
- Document all validation activities and results.
GDP Controls: Good Documentation Practices (GDP) must be adhered to throughout the validation process, ensuring all records are accurate, complete, and retrievable.
Acceptance Criteria Governance: Acceptance criteria will align with the User Requirements Specification (URS), Annex 11, and 21 CFR Part 11 to ensure compliance and data integrity.
Calibration/PM Governance: Regular calibration and preventive maintenance must be performed in accordance with the manufacturer’s recommendations and internal SOPs to maintain system functionality and accuracy.
Change Control Triggers: Any changes to the NDDS Process Control System, including software updates, hardware modifications, or changes in operational procedures, will trigger a change control process and may require revalidation.
Revalidation Triggers and Periodic Review: Revalidation will occur after any significant change as defined in the Change Control section. A periodic review of the validation status will be conducted annually or as required by regulatory changes.
Records/Attachments List:
- User Requirements Specification (URS)
- Validation Protocols (DQ/IQ/OQ/PQ)
- Calibration Records
- Change Control Documentation
- Periodic Review Reports