Product Performance Qualification Validation Methods

There are many validation processes set by the authorities to check product performance qualification and ensure whether a pharmaceutical test method is valid for its intended use or not. The test method validation involves a series of experiments performed on the material, procedure and equipments that in the end validates the method. It is given through statistical analysis and a pre defined an acceptance criterion that is applied to the method’s result.


  • Accuracy
  • Precision
  • Specificity
  • Limit of detection
  • Limit of quantization
  • Robustness

The main purpose of the validation process is to test and determine the suitability of the method with staff and the laboratory. It can also be done by collaborating different laboratories. The methods can vary for different analytical procedures.

There are four different types of validations:

Prospective validation: This validation is usually performed at the development stage. It includes different steps for the division of production process and also the critical points like temperature or the mixing time.

Concurrent validation: This process is carried out at the time of normal production. It demands full understanding of the process. It includes close monitoring of all the steps for manufacturing the determination of pH value, variation of weight, hardness of the product, uniformity of the content, viscosity, density, clarity, color, unit potency and more.

Retrospective validation: This process of validation is used for determining the consistency of the method from the results taken from past production. It includes close analysis on test result and deviation during the process.

Revalidation: This is to check whether the systems are consistently operating as validated originally. The process must not be affected by the changes made later.

Best Biopharmaceutical Companies

Medical industry is developing massively. Today, there are many hospitals, clinics and medical stores that supply different types of medicines for different problems and issues. If you want to buy any type of biochemicals, antibiotics, analytical reagents, etc. you can easily buy online through Biopharmaceutical Company. These companies have all types of medicines and chemicals that you are looking for. All the drugs are properly tested in the laboratory and then go for sale. Many companies also provide discount when you buy their products online.

How to find the correct company for buying any drug or chemicals?

  1. Certification – carefully look at the home page of the company and search whether the company is certified or not. There are many companies in the medical field which are not fully certified and sell products. This can be risky as they can give you expired or untested products which can cause harm to your customers or patients. Only buy products after checking the certification stamp on the company’s website.
  2. Online reviews – online reviews can help you to see whether the company is reliable or not. Check for the positive reviews and compare the ratio to the negative ones. A good company should have at least 30+ reviews on their official site.
  3. Detailed description of each product – when you are looking for a good biopharmaceutical company, check whether the company provides a detailed description of the product or not. Check the formula of the particular chemical or medicine that you want to buy. This will ensure that the drugs are safe and do not contain any impurities.