Validation in a pharmaceutical setting provides workers with the confidence that their products are being manufactured to the highest standard on a consistent basis. It is a crucial aspect of Good Manufacturing Practices (GMP) in the pharma industry, and it’s an area of expertise that is possessed by quality assurance and quality control graduates.
It involves a thorough review of each step of the pharmaceutical process, from drug design to equipment installation, and from manufacturing to packaging. Different methods of validation are used depending on a variety of factors.
The process of validation must always remain an ongoing consideration. The introduction of a new process or piece of equipment to the production of an existing drug warrants revised validation processes and the implementation of new measures. Keep reading to learn more about validation in pharmaceutical quality control.
Prospective Validation is Necessary Before Production Begins
Prospective validation is usually carried out on new formulas, or within new manufacturing plants. All of the pharmaceutical processes involved in the creation of the drug are scrutinized before production gets underway.
This allows pharmaceutical quality assurance professionals to isolate potential problems, therefore preventing the potential production of large batches of ineffective products. Three batches or production runs are usually analyzed as part of this validation process to ensure that a robust test has taken place. Comprehensive documentation of validation results is needed for each run.
Concurrent Validation Takes Place During Drug Production
Concurrent validation takes place in conjunction with production, which creates additional risk if the validation uncovers problems in the process. Therefore, this method is usually only used in special circumstances and only if the processes have been previously validated.
The concurrent method could be used when the processes have been acquired by a new company and are being moved to a new manufacturing facility. Slight alterations may also have been made to the ingredients of the product.
The benefit of the concurrent validation method is that the products continue being manufactured during testing, and there’s less waste of time and ingredients if processes are eventually deemed safe and effective.
What to Know About Retrospective Validation in Quality Control Training
This validation method involves judging the efficacy of pharmaceutical processes through the analysis of historical data. Professionals may look at the existing results relating to the performance of their manufacturing equipment and determine that the process is working adequately.
Batch documents, maintenance log books and test results are among the sources that are often used in retrospective validation. This method isn’t employed very often, except for cases where processes are already well-established.
The Circumstances in which Revalidation is Needed
Revalidation may also be overseen by professionals with quality control training to ensure the ongoing efficacy of pharmaceutical processes. Like concurrent validation, it may be used when a product is being transferred to a new manufacturing plant.
Revalidation is also essential if significant changes have been made to the ingredients of the product, or even alterations to plant cleaning processes. The same documentation is required for this method as the initial prospective validation, so this is also a comprehensive undertaking.
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