temperature, pressure, pH levels)

Frequency of data collection and reporting

User interface requirements for ease of understanding

Compliance with 21 CFR Part 11, ensuring electronic records are trustworthy and reliable

Once the URS is established, conduct a risk assessment to identify potential failures in the SCADA/PLC interface that could compromise data integrity. Tools like Failure Mode and Effects Analysis (FMEA) or Risk Priority Number (RPN) can aid in evaluating risks. Ensure that risk mitigation strategies are clearly defined, particularly concerning cleaning validation in pharmaceutical settings, where contamination control is paramount.

Step 2: Protocol Design for Integration and Validation

After establishing the URS and conducting a risk assessment, the next step is to design your validation protocol. This document outlines the approach for integrating SCADA and PLC outputs into CPV dashboards and specifies how cleaning validation in the pharmaceutical industry will correlate with these outputs.

When drafting the protocol, it should include the following components:

• Scope of validation, highlighting specific processes and equipment
• Roles and responsibilities of validation team members
• Detailed methodology for testing the system integration, emphasizing data quality attributes such as accuracy, completeness, and consistency
• Acceptance criteria for system functionality

Furthermore, all protocols should align with regulatory guidance, particularly the principles established in ICH Q9 (Quality Risk Management). This includes defining appropriate statistical methods for validating the CPV data collected via SCADA and PLC systems. Utilize control charts or process capability indices to evaluate performance against defined specifications.

Step 3: Execution of the Qualification Process

Execution of the qualification process is a critical step that verifies the system operates as intended. This phase typically encompasses Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure the SCADA/PLC outputs meet the established URS and function effectively within the CPV dashboard.

The Installation Qualification phase should ascertain that the SCADA and PLC systems are installed following manufacturer specifications and that all necessary configurations are completed. Document all steps with clear, reproducible evidence that the systems are correctly set up.

For Operational Qualification, the focus shifts to verifying that the system operates correctly under expected conditions. Perform tests that mimic routine operations, and document software configuration settings, data capture points, and communication protocols between SCADA, PLC, and the CPV dashboard.

Lastly, in the Performance Qualification, it is vital to demonstrate that the integrated system performs effectively within specified parameters over a defined period. Validate that the system not only captures data accurately but also that it processes that data correctly within the context of cleaning validation in pharma. Consider conducting a dry run of CPV with historical data before going live, thus confirming that data integrity is maintained throughout the process.

Step 4: Performance Qualification (PQ) and Process Performance Qualification (PPQ)

Following the qualification phases, it is essential to conduct Performance Qualification (PQ) and Process Performance Qualification (PPQ). PQ ensures that the equipment and systems perform effectively under simulated conditions, while PPQ ascertains that the overall manufacturing process is capable of delivering consistent product quality.

During PQ, document test results meticulously, matching them against defined criteria. Include considerations such as:

• Batch sizes and variations in raw materials
• Environmental conditions that may impact operations, notably during cleaning validation
• Evaluation of actual production disruptions and their effects on data accuracy and reliability

Upon successful completion of PQ, initiate the PPQ phase. This involves executing a series of production runs under routine operations to further confirm that the integrated system captures data accurately. PPQ also serves as an opportunity to specify the required cleaning validation between production batches, ensuring no residues from previous processes compromise the quality of the batch currently being produced.

Document all findings and deviations, correlating any variances back to the established URS and risk assessments. Regulatory expectations for this phase emphasize establishing a robust foundation for continued monitoring during the CPV phase.

Step 5: Continued Process Verification (CPV)

Once the PQ and PPQ processes have been validated, the focus transitions to Continued Process Verification (CPV). CPV involves the ongoing monitoring of the performance of the manufacturing process, including data generated from SCADA and PLC systems integrated into the CPV dashboards. This continuous feedback loop is crucial for identifying trends and variations that may indicate issues with the manufacturing process or cleaning validation.

To effectively implement CPV:

• Establish key performance indicators (KPIs) from historical data that will serve as benchmarks for performance evaluation
• Automate data collection and trending processes using SCADA and PLC outputs to ensure real-time monitoring of KPIs
• Institute periodic reviews of collected data, analyzing trends and peaks that could represent underlying issues

Documentation is imperative during the CPV phase; retain accurate records demonstrating adherence to regulatory requirements and the effectiveness of your cleaning validation strategy. Utilize statistical methods to regularly assess process capability and identify any need for further investigation into manufacturing variations.

Step 6: Revalidation and Change Control

As part of the validation lifecycle, revalidation is essential, particularly when there is a process change, new equipment introduction, or significant alterations to cleaning methods. This step ensures that the systems remain compliant and effective in capturing accurate data for CPV dashboards.

To manage revalidation effectively:

• Define criteria for when revalidation is necessary, such as significant changes in input materials, equipment modifications, or alterations in cleaning procedures
• Conduct a thorough risk assessment for any proposed changes, referencing the original URS and ensuring that the level of quality assurance remains consistent
• Document the entire revalidation process, confirming adherence to both internal policies and external regulatory requirements

Regulatory bodies emphasize the importance of maintaining validation status, particularly through ongoing data integrity checks. Continuous reevaluation establishes a culture of quality and accountability that is crucial for successful manufacturing operations in the pharmaceutical industry.

Conclusion

The integration of SCADA and PLC outputs into CPV dashboards is a complex yet essential task that requires stringent adherence to quality assurance principles and regulatory expectations. By following the steps outlined in this article, pharmaceutical professionals can ensure that their cleaning validation practices are robust, compliant, and capable of maintaining the high standards expected in the industry.

By adopting a structured validation lifecycle approach—from initial URS development through to ongoing CPV and revalidation—QA, QC, and validation teams can significantly enhance their operational efficiencies while ensuring product quality and compliance in the rapidly evolving landscape of pharmaceutical manufacturing.