The significance of validation of pharmaceutical water systems can be gauged from the fact that among the number of substances, raw materials and starting materials used in the production, processing and formulation of pharmaceutical products; water takes a position of primacy. This is because the hydrogen bonds that water has, along with its polarity, lend it a set of special chemical properties. Because water has these attributes; many different compounds are able to blend with it in the form of dissolving, absorbing, adsorbing or suspension.
Yet, there is an irony, because this very unique quality of water –of its being able to blend easily –which makes it so important, also makes it a magnet and breeding ground for many contaminants. Water can meld different compounds, as well as contaminants. This is why effective and proper validation of pharmaceutical water systems is necessary and important.
Approaches to validation of pharmaceutical water systems
Validation of pharmaceutical water systems can be approached in three ways: prospective, concurrent and retrospective.
As the names suggest, prospective validation of pharmaceutical water systems is the validation that is carried out when an altogether new product is about to be introduced, or when there is a change in the process, which is likely to impact the attributes of water in the pharmaceutical product.
Concurrent validation of pharmaceutical water systems is the one that is carried out during the manufacturing process.
Retrospective validation of pharmaceutical water systems is one that is carried out after the product is out it the market. This is usually carried out when the company receives complaints about the product quality.