Procedure for Process Validation in Pharmaceuticals : Pharmaguideline

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Procedure for Process Validation in Pharmaceuticals

Learn process validation procedure step by step that is followed in pharmaceutical manufacturing industry.
Process validation is an important part of pharmaceutical industry. It helps to identify and resolve the issues that arise during manufacturing process. Process validation ensures the consistency and reliability of the quality product manufacturing on pharmaceuticals. Following steps are followed during the validation of manufacturing process in pharmaceutical industry.

1. Define the Scope and Objective

Create the outline of the validation process including the process, equipment and the personnel involved in the whole validation activity. Also define the objective and goal of the process validation.

2. Develop a Validation Plan

Create a validation plan for process validation including method of validation, timeline, required resources and the responsibilities of the involved personnel. This validation plan should follow the regulatory guidelines for validation and qualification.

3. Stage 1: Process Design

A. Understanding the Process: Understand the manufacturing process properly with its critical process parameters and impact of these parameters on the quality of pharmaceutical products.

B. Risk Assessment: A risk assessment of process is necessary to identify the risks associated with the process those can affect the product quality.

C. Design of Experiments:
Design and select the experiments that shall be used in process validation study. This will help to optimize the process parameters and variables.

4. Stage 2: Process Qualification

A. Installation Qualification (IQ): In this step all the equipment and systems used in the manufacturing process are checked for proper installation according to the specification.

B. Operational Qualification (OQ): In this step of process validation, it is verified that equipment operates according to the predefined specifications and all the functions of equipment are running properly.

C. Performance Qualification (PQ): This step is conducted to verify that manufacturing process produces a quality product according to the predefined specification consistently.

5. Stage 3: Continued Process Verification

A. Monitoring of Process: Create and implement a system to monitor the system continuously to ensure that the validated system is stable and consistent.

B. Change Control: Establish a change control management system to monitor the changes done in the validated process that will ensure that changes do not have any adverse effect on the product quality.

C. Review the System Periodically: Review the validated system at a predefined interval and assess the impact of any significant change made in system or procedure.

6. Documentation and Reporting

A. Validation Report: A validation report is created after analyzing all the validation data and results are reported in the report. This validation report will be required in different regulatory audits.

B. Document Management: Maintain all the documents related to the validation process. Validation activities like validation protocols, validation reports, deviations occurred during validation, and any corrective and preventive actions taken during process validation are documented properly.

7. Regulatory Compliance

It is to ensure here that all validation activities are done as per the current regulatory requirements. Prepare the validation documents according to the requirements of regulatory agencies like FDA, WHO, EMA and country specific local regulatory agencies. Submit the validation data to the regulatory agencies as it is required for any approval.

8. Training of Personnel Involved in Manufacturing Process

Provide proper training to all the personnel involved in the manufacturing process to ensure that everyone knows about the validated system. It will help to run the process smoothly and consistently. Quality assurance should review the whole validation process to ensure that the validation process is executed as per the established procedures and standards.

9. Closure and Continuous Improvement

Conclude the whole validation and summarize the results against the acceptance criteria. Implement the corrective actions done during the process validation, if required, change the process according to the corrective actions using a change control system.

Process validation is a continuous process that never ends, every process is required to revalidate after any change that is done as process improvement. By following above steps, you can easily conduct a process validation in pharmaceutical manufacturing. If you face any issues during process validation, feel free to contact us.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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