GPS Service offers a complete suite of Computer System validation and compliance services led by a core team of highly qualified, scientifically trained Control System Validation specialists capable of delivering:

• QC Equipment

• Manufacturing equipment

• Water Systems

• Manufacturing Execution systems

• SCADA Based System

• DCS Based System

• PLCs Based System

• Automated packaging equipment

• Labelling equipment & Packaging System

• Visual Inspection System

• Track and Trace System

• Robotic system

• Building management System

• Environment Management System

• Facility management system

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What is the definition of Process Validation ?

Process validation is the documented and systematic approach of confirming that a manufacturing process consistently produces products meeting predetermined quality standards and regulatory requirements.

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Process validation typically involves three stages:

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Stage 1 - Process Design:

In this stage, the critical quality attributes (CQAs) of the product are identified, and the manufacturing process is designed and developed to meet these CQAs. It involves defining the process parameters, ranges, and acceptable operating ranges based on scientific understanding and risk assessments. Quality risk management principles are applied to identify and control potential sources of variability that could impact product quality.​

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Stage 2 - Process Qualification:

During this stage, the process is demonstrated to consistently produce products that meet the predetermined specifications. This is achieved by conducting a series of experiments and tests under normal operating conditions to gather empirical data. Process performance is evaluated by analyzing the collected data and comparing it to the established criteria. The key elements of process qualification are Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• IQ: Verifies that all equipment and utilities are correctly installed and meet specifications.

• OQ: Demonstrates that the equipment operates according to its intended function and within defined operational limits.

• PQ: Confirms that the process consistently produces products that meet predetermined quality attributes.​

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Stage 3 - Continued Process Verification:

After successful process qualification, ongoing monitoring and verification of the manufacturing process are essential to ensure continued product quality. This stage involves periodic monitoring of process performance through the collection and analysis of relevant data. It aims to detect any trends or deviations that may indicate a potential drift from established control limits. The data collected during this stage helps in making informed decisions about process changes and improvements.

Process validation is an ongoing lifecycle approach, and continuous improvement is encouraged to ensure the highest level of product quality and patient safety. It requires collaboration between various departments, including manufacturing, quality assurance, regulatory affairs, and research and development, to ensure a robust and effective validation process. Additionally, process validation plays a critical role in meeting regulatory requirements, such as those outlined in the FDA's Process Validation Guidance and ICH Q7 guidelines for pharmaceutical manufacturing.

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We provide facility for Process Validation:

 

• Validation Experts: Employing experts experienced in process validation who can assist clients in developing and executing process validation protocols.

• Validation Equipment and Resources: Providing the necessary equipment, instruments, and resources required for conducting process validation studies.

• Documentation and Reporting: Assisting clients in generating and maintaining the required validation documentation and reports.

• Regulatory Compliance: Ensuring that the process validation activities adhere to relevant regulatory guidelines and industry standards.

• Process Optimisation: Offering support in optimising manufacturing processes to achieve consistent product quality and efficiency.

• Risk Assessment and Mitigation: Helping clients identify potential risks in their processes and implementing risk mitigation strategies.

• Training and Competency Development: Providing training to client personnel involved in process validation to ensure they understand and follow best practices.

• Continuous Improvement: Encouraging a culture of continuous improvement in process validation activities.

 

In the pharmaceutical industry, Process Validation in Computer System Validation (CSV) refers to the systematic and documented approach of demonstrating that a computerised system, such as a laboratory information management system (LIMS), manufacturing execution system (MES), or a data acquisition system, consistently performs as intended throughout its lifecycle and meets predefined quality and regulatory requirements.

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Process Validation in CSV is essential to ensure the integrity, reliability, and accuracy of data generated by computerized systems in the pharmaceutical manufacturing and laboratory processes. The goal is to establish confidence in the computer system's performance, especially in critical areas such as data integrity, security, and compliance with regulatory requirements.

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The process of Process Validation in CSV typically involves the following key steps:

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• User Requirements Specification (URS): The validation process begins with defining clear and comprehensive user requirements for the computerised system. The URS describes the system's intended use, functionalities, and performance expectations from the end-user perspective.

• Functional Specification (FS): The functional specification translates the user requirements into technical specifications, detailing how the system will achieve the desired functionalities.

• Risk Assessment and GxP Impact Analysis: A risk assessment is conducted to identify potential risks and impacts associated with the computerised system on product quality, data integrity, patient safety, and regulatory compliance. This analysis helps prioritise validation efforts and determine the scope of validation activities.

• Installation Qualification (IQ): IQ ensures that the computerised system is correctly installed, including hardware, software, and network components. It verifies that the system meets predefined specifications and is set up according to manufacturer recommendations.

• Operational Qualification (OQ): OQ demonstrates that the computerised system functions as intended and performs all specified functions correctly. Test cases are executed to verify the system's functionalities and validate critical system configurations.

• Performance Qualification (PQ): PQ confirms that the computerised system consistently performs within its defined operating ranges and provides accurate and reliable results. It involves executing test cases using production-like data and scenarios to simulate real-world usage.

• Data Integrity Testing: A critical aspect of Process Validation in CSV is data integrity testing, where the system's ability to maintain data integrity, including data entry, storage, retrieval, and reporting, is thoroughly assessed.

• Change Control and Ongoing Verification: After successful validation, any changes to the computerised system, such as updates, patches, or upgrades, should follow a change control process. Ongoing verification and periodic reviews ensure that the system continues to meet the required performance standards.

• Documentation and Reporting: All validation activities, results, deviations, and corrective actions are documented in validation reports, which serve as evidence of compliance during regulatory inspections and audits.

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Process Validation in CSV is a critical component of the pharmaceutical industry's quality assurance and regulatory compliance efforts, ensuring that computerised systems used in drug development, manufacturing, and quality control consistently produce reliable and accurate data while meeting industry standards and regulatory requirements.