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    Process Validation

    As it relates to the spray equipment, the process of validation involves the qualification of the manufacturing process to ensure that it is stable and reliable so that the corresponding manufactured drugs meet specifications. Once an equipment or a process is validated, a new validation is required if any change is made.

    Becky Whitney - Job Role

    Process validation is a systematic and documented approach used in various industries, particularly pharmaceuticals, biotechnology, medical devices, and food manufacturing, to confirm that a specific manufacturing or production process consistently produces products that meet predetermined quality, safety, and efficacy standards. The goal of this activity is to ensure that a manufacturing process is robust, reliable, and capable of consistently producing high-quality products.

    Principles and elements of process validation

    Key principles and elements of this activity typically include:

    Process Design

    Before validation begins, the manufacturing process must be carefully designed, taking into account critical process parameters, materials, equipment, and operating procedures. Process design includes defining process inputs and outputs, as well as identifying critical quality attributes (CQAs).

    Installation Qualification (IQ)

    IQ is the first step and involves verifying that all equipment, instruments, and systems are installed correctly and function as intended. This includes ensuring that equipment is properly calibrated and maintained.

    Operational Qualification (OQ)

    OQ involves testing and documenting the performance of equipment and systems under operational conditions. It verifies that equipment operates within specified parameters and tolerances.

    Performance Qualification (PQ)

    PQ is the final stage of validation and focuses on ensuring that the entire manufacturing process consistently produces products that meet predefined quality specifications. It involves testing and documenting the process under actual production conditions to demonstrate its consistency and reliability.

    Validation Protocols

    Detailed validation protocols are developed to outline the specific tests, procedures, and acceptance criteria for each qualification stage (IQ, OQ, and PQ). These protocols are followed precisely during the validation process.

    Data Collection

    During each validation stage, data is collected and analyzed to ensure that the process consistently produces products meeting predefined quality criteria. This data-driven approach provides evidence of process performance.

    Validation Reports

    Comprehensive validation reports are generated, summarizing the results of each validation stage. These reports provide evidence that the manufacturing process is capable of consistently producing high-quality products.

    Change Control

    Any changes to the validated process, equipment, or materials must go through a formal change control process. Changes must be evaluated for their potential impact on product quality and may require revalidation.

    Continued Monitoring

    After successful validation, ongoing monitoring and process control are essential to ensure that the validated process continues to perform as expected. This includes routine quality control and process monitoring activities.

    Why is process validation used

    Process validation is essential in highly regulated industries like pharmaceuticals and biotechnology to meet regulatory requirements and ensure patient safety. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established guidelines and expectations for the validation. Successful process provides confidence that a manufacturing process consistently produces products that meet quality and safety standards, reducing the risk of product failures and recalls.

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