“Well-designed tests as a basis for good validation of the pharmaceutical process. Why is testing important?”
Most pharmaceutical companies see the validation process as a legal obligation and a business aspect, that is simply COST. Let's try to look at validation from a slightly different, more friendly side. Let's look at it as a tool in the hands of a specialist, which, when used in the right way, will allow you to optimize the costs and activities related to our processes.
Let's start from the beginning. What is validation?
Validation is providing documented evidence to confirm the processes and supporting computerized systems are fit for purpose. It is also about patient safety, product quality as well as reliability and credibility of the company delivering the product to the market.
What types of validation do we have?
The main types of validation include:
- Validation of computerized systems
- Validation of analytical methods
- Cleaning validation
- Manufacturing process validation
- Validation of the packaging process
- Transportation validation
As mentioned in the beginning, validation generates costs. In particular, the law imposes an obligation on the pharmaceutical sector to perform all the above-mentioned types of validation. But does each of us know that a well-designed and conducted validation can reduce expenses in the future?
To make all this happen, let's design the validation in a group of experts who, thanks to their knowledge and experience, will allow you to look at the process from every possible angle. Experts will break down the process into prime factors, so as to extract from it what is most important, what should be paid special attention during validation.
We should also remember not to be afraid to talk, express our doubts, ask, use critical and creative thinking. All this will allow us to plan validation, and especially the heart of validation, i.e., tests in an optimal way.
Why is testing "at the heart of validation"?
1. Tests are a source of information
Tests provide us with reliable data, evidence that shows how our process works. The point is not to do a million tests that lead to nothing, generate time, artificial documentation, and many information that we cannot process. Well-designed tests focus on relevant, critical factors. Factors that affect the quality and safety of the patient. Optimized tests provide enough data to show how the process is going, assess its correctness and estimate how it will behave in the future. To summarize this point, to get valuable tests it is important to use risk-based and requirements-based testing.
2. Tests minimize the risk
We test a process that we do not know. We want to check how a given technology will behave in a real environment. In the environment in which we will use it on a daily basis. Let us remember that nothing is perfect and, just like in our life, flaws may also occur in our process. Thanks to testing, we will be able to spot these defects at an early stage of the project and implement effective solutions to remove the problem. Such activities will allow you to enter standard production with minimized risk and an optimized process.
3. Tests are cost-effective
Validation, and thus testing, is the time when we can afford to detect defects in our process. The detection of defects at the validation stage reduces costs in the future. Validation is the stage when we can still improve our technology, later in standard production there will be no time for it.
A well-validated process is a stable process. A stable process means fewer deviations, less corrective actions, fewer changes in process and thus lower expenses, time savings, optimized work, satisfied employees and customers.
4. Tests are quality
Testing allows you to check how well our process / technology is working. So, it allows you to check the quality of our product and thus ensure its compliance with legal requirements.
So let's not waste any time. We strive to wisely optimize our activities, providing us with reliable evidence confirming the quality of our processes.