Process validation

Process validation
See also
Quality control plan External quality assurance Quality plan Software development process HACCP system Validation master plan Management system Operational control Flow analysis

Process validation is an essential element of quality management and is defined as the process of collecting and evaluating evidence that a process consistently leads to the expected outcome in compliance with regulatory requirements. The purpose of process validation is to ensure that a process is capable of consistently delivering products that meet predetermined requirements and quality standards. It is an ongoing process of evaluation, assessment and improvement that is incorporated into the design and manufacturing process. Process validation involves the development, review and approval of validation protocols, the execution of process validation activities and the preparation and approval of validation reports. It is the responsibility of management to ensure that an effective process validation program is implemented and maintained throughout the life cycle of the product.

Example of process validation

• Process validation of a manufacturing process: This involves collecting data from the process and evaluating it to determine if the process is consistently producing a product that is of the required quality and meets the predetermined requirements. This may include documenting process flows, testing product samples, observing process performance, and identifying process parameters that need to be monitored and controlled.
• Process validation of an analytical method: This involves collecting data from the method and evaluating it to determine if the method is consistently producing accurate and reliable results. This may include validating the equipment used for the method, establishing test procedures, validating the accuracy and precision of the method, and verifying the integrity of the data generated by the method.
• Process validation of a cleaning process: This involves collecting data from the process and evaluating it to determine if the process is consistently producing a product that is free from contamination. This may include establishing a cleaning procedure, testing the process to verify its effectiveness, and monitoring the process to ensure that it is being properly followed.

When to use process validation

Process validation is an important element of quality management, and it can be applied in a variety of contexts. Process validation is typically used for:

• New product development: to ensure that the process used to produce the product meets the required specifications and meets the needs of the end user.
• Process improvements: to ensure that changes to the process result in a product that meets the desired requirements.
• Regulatory requirements: to demonstrate compliance with applicable regulations and standards.
• Manufacturing Transfer: to ensure that the process used to manufacture a product is consistent when transferred to a new location or facility.
• Process Troubleshooting: to identify and correct any problems that may be affecting the process.
• Change Control: to ensure that any changes to the process are properly evaluated and approved before being implemented.

Types of process validation

Process validation is an essential element of quality management and is defined as the process of collecting and evaluating evidence that a process consistently leads to the expected outcome in compliance with regulatory requirements. There are several different types of process validation including:

• Installation Qualification (IQ): Installation qualification is the process of verifying that the equipment and systems used for manufacturing are installed correctly and meet the required specifications.
• Operational Qualification (OQ): Operational qualification is the process of verifying that a system or process is capable of consistently performing according to its design.
• Performance Qualification (PQ): Performance qualification is the process of verifying that a process or system is capable of consistently delivering the expected results.
• Process Validation (PV): Process validation is the process of verifying that a process is capable of consistently producing products meeting predetermined specifications and quality standards.
• Continuous Process Verification (CPV): Continuous process verification is the process of monitoring and verifying the performance of a process over time to ensure that it is consistently meeting the desired specifications.
• Design of Experiments (DOE): Design of experiments is an analytical process used to identify the most effective combination of process parameters that yield the desired product.

Steps of process validation

Process validation is an essential element of quality management and is defined as the process of collecting and evaluating evidence that a process consistently leads to the expected outcome in compliance with regulatory requirements. The purpose of process validation is to ensure that a process is capable of consistently delivering products that meet predetermined requirements and quality standards. To ensure the successful implementation of a process validation program, the following steps should be taken:

• Planning: This involves creating an initial plan for the validation process and identifying the resources needed to complete the validation activities. The plan should include the scope of the process, the requirements for the validation, the activities to be completed, and the timeline for completion.
• Design Qualification: This refers to validating the design of the process to ensure that it is capable of consistently producing the desired outcome. This may include verifying that the process is designed to meet customer requirements, validating the software used in the process, and validating the process parameters to ensure that they are operating within specified limits.
• Process Qualification: This refers to validating the process to ensure that it is capable of consistently producing the desired outcome. This may include conducting trials to determine if the process is operating correctly, monitoring the process to ensure that it is meeting performance requirements, and verifying that the process is producing products that meet the desired quality standards.
• Verification: This refers to validating the results of the process to ensure that they are consistent with the desired outcomes. This may include conducting inspections to ensure that the process is operating correctly and that the results are consistent with the quality standards.
• Documentation: This involves documenting the results of the process validation activities and preparing a validation report. The report should include the validation plan, details of the validation activities, and the results of the activities.

Advantages of process validation

Process validation is an important quality management practice that ensures that processes consistently produce products that meet predetermined requirements and quality standards. The benefits of process validation include:

• Enhanced product quality and performance - Process validation helps ensure that the product meets all relevant specifications and quality requirements.
• Improved process efficiency - Process validation helps identify and eliminate errors, reduce waste, and increase process throughput.
• Reduced costs - Process validation can help reduce costs by reducing waste, increasing efficiency, and improving product quality.
• Increased customer satisfaction - Process validation can help ensure that products meet customer needs, resulting in increased customer satisfaction.
• Regulatory compliance - Process validation ensures that all relevant regulations and standards are met.

Limitations of process validation

Process validation is an important element of quality management, however, there are some limitations to it. These include:

• Lack of flexibility: Process validation is a structured and systematic approach to verifying the quality and consistency of a process. It is not very flexible and may result in restricted process capability.
• Time consuming: Process validation is a time-consuming process and requires resources for implementation, which can be costly for companies.
• Difficulty in predicting the future: Process validation is based on past performance and does not account for changes in the environment that can affect future performance.
• Difficulty in establishing acceptance criteria: Establishing acceptance criteria for a process can be difficult and requires an understanding of the process and its variability.
• Subjectivity: Process validation is subjective and requires experienced personnel to interpret the data and assess the results.
• Resistance to change: Process validation may be resistant to changes, resulting in an inefficient process.

Other approaches related to process validation

Process validation is an essential element of quality management and is defined as the process of collecting and evaluating evidence that a process consistently leads to the expected outcome in compliance with regulatory requirements. Other approaches related to process validation include:

• Process design: This involves developing a detailed understanding of the process and identifying potential areas of risk. It also involves designing and testing production processes to ensure that they meet customer requirements and regulatory standards.
• Process control: This involves monitoring the process to ensure that it is running as expected and that any changes are documented and communicated as needed. This also involves taking corrective action if necessary to ensure that the process remains in control.
• Process improvement: This involves continually reviewing and improving the process to ensure that it is running as efficiently as possible. This may include the introduction of new technologies or process improvements.

In summary, process validation is an essential part of quality management and involves the development, review, and approval of protocols, the execution of validation activities, and the preparation and approval of validation reports. Other approaches related to process validation are process design, process control, and process improvement.

Suggested literature

• Swarbrick, J. (2003). Pharmaceutical process validation (No. 22150). R. A. Nash, & A. H. Wachter (Eds.). New York: Marcel Dekker.
• Cook, J. E., & Wolf, A. L. (1999). Software process validation: quantitatively measuring the correspondence of a process to a model. ACM Transactions on Software Engineering and Methodology (TOSEM), 8(2), 147-176.