Deal qualification process for pharmaceutical

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hi friends welcome to a new learning video on Pharmaguideline today we will explore process validation process validation is documented evidence that a process such as manufacturing or packaging consistently produces a product that meets predetermined specifications and quality attributes it is a crucial step in ensuring the safety and efficacy of pharmaceutical products process validation is a step-by-step procedure designed to ensure that a manufacturing process can consistently produce quality products it is performed by a validation team led by the quality assurance head in the pharmaceutical industry generally process validation is done before releasing a new product when applying any change to an existing product and for periodically verifying the process the process validation process involves a series of stages Each of which plays an essential role in ensuring that pharmaceutical products are safe and effective in this video we will explore the three stages of process validation in Pharmaceuticals in more detail stage 1 process design stage 2 process qualification stage 3 continued process verification the first stage of process validation is process design during this stage the manufacturing process is planned and designed this involves defining the critical quality attributes of the drug product which are the physical chemical biological or microbiological characteristics that affect the product safety and efficacy critical quality attributes may include factors such as the drugs Purity potency and stability once the critical quality attributes have been defined the critical process parameters that affect these attributes identified critical process parameters are the factors in the manufacturing process that can impact the critical process parameters such as temperature pressure and pH for example the temperature at which a drug product is manufactured can significantly affect its stability potency and purity after the critical process parameters have been identified the manufacturing process is designed to ensure that these parameters are controlled within the defined specifications the process design also establishes the control strategy that will be used to ensure the process consistently meets the defined specifications the control strategy may include monitoring and testing critical process parameters and the use of quality control tests to verify that the drug product meets the defined specifications once the process design is complete the manufacturing process is validated through a series of qualification stages the first stage is installation qualification during this stage the manufacturing equipment is installed and tested to ensure it meets the defined specifications the IQ stage may include equipment calibration verification of installation and operational procedures and documentation of equipment performance the second stage of process qualification is operational qualification during the oq stage the manufacturing process is tested to ensure it consistently produces the drug product within the defined specifications under normal operating conditions this may involve testing the performance of the manufacturing equipment and verifying that the critical process parameters are within the specified limits oq testing typically involves the use of standardized protocols such as process mapping control charts and statistical process control the final stage of process qualification is performance qualification in this stage the manufacturing process is tested under actual production conditions to demonstrate that it can consistently produce the drug product that meets the defined specifications PQ may include testing the process with various batches of the drug product to ensure that the manufacturing process is robust and reliable PQ testing may also involve testing the drug product stability under various conditions such as different storage temperatures and humidity levels in the third stage after the manufacturing process has been validated it is continuously monitored to ensure it remains in a state of control this stage is called continued process verification it involves routine monitoring of process performance and product quality to detect any Trends or shifts that may indicate the process is not operating as expected continued process verification may include the use of statistical process control charts and trending analysis to identify any changes in the manufacturing process or the drug product that may affect its quality or consistency if any issues are detected corrective actions are taken to bring the process back into control and the process is revalidated as needed continued process verification is critical in ensuring that the manufacturing process remains consistent and reliable over time it also helps to ensure that the drug product remains safe and effective even as production volumes increase or new batches are produced there are four main types of process validation first is prospective validation it is implemented when any product will be manufactured with a new formula or within a new facility also known as pre-market validation prospective validation is usually carried out before commencing routine production it is also considered the foundational type of validation because it is the starting point for any product that will be released under new conditions the second type of validation is retrospective validation it is conducted only when the manufacturing process has not formally undergone a documented validation retrospective validation is normally fulfilled with the use of historical data and Trends analysis to provide evidence that the process is at a state that it is intended to be in in most cases it is no longer an acceptable approach to process validation because any product should have already been validated before its commercial distribution the third type is concurrent validation this type of validation involves monitoring and validating a process as it is in use concurrent validation is useful in ensuring that a process is consistently producing quality products or services and can help identify any issues that arise during regular use the fourth type of process validation is revalidation revalidation means repeating the original validation effort or any part of it and includes an investigative review of existing performance data this approach is essential to maintain the validated status of the manufacturing processes possible reasons for starting the revalidation process may include transfer of a product from one plan to another changes to the manufacturing process or cleaning process the necessity of periodic checking of the validation results increase or decrease in batch size or sequential batches that fail to meet product specifications it's important to note that process validation is an ongoing process and should be regularly reviewed and updated as necessary to ensure that the process continues to produce consistent quality products or services validation of all major pharmaceutical systems and processes are very essential it ensures the quality of products manufactured in facility let us know some benefits of process validation when it is implemented in pharmaceutical Manufacturing process parameters and controls are determined during the validation of any process or system it helps to determine the worst case and risks that may arise during the manufacturing of quality products process validation helps to investigate the deviations caused during the process deep study and understanding of the process and Equipment are made possible due to the process validation the risk of regulatory non-compliance is minimized after the process validation a validated process required less process control in the finished product testing batch to batch variation is minimized due to the validation of processes systems and equipment it increases the production of the manufacturing facilities due to minimized rework and rejection it decreases the chances of the failure of batches process validation is a necessary step in ensuring that products are manufactured consistently and meet predetermined specifications and quality standards by validating a process organizations can identify potential problems and defects early on saving time and money moreover process validation is required by regulatory bodies in many Industries to ensure compliance with regulations and guidelines such as cgmp ISO and FDA the benefits of process validation include improved consistency reliability cost Effectiveness customer satisfaction and enhanced reputation therefore it is crucial for organizations to implement a robust process validation program as a part of their quality management system to ensure the safety and quality of their products don't forget to subscribe to this Channel and also hit the Bell icon to get regular updates thanks for watching this video