Water System Validation
One of the most indispensable components in manufacturing of all pharmaceutical
products is purified water. Validation of the water system is necessary to ensure
that the specified quality of water is consistently produced. If you’re a
pharmaceutical manufacturer, water system validation is certainly indispensable for
the production of your pharmaceutical products.
Indeed, water is a significant component of every pharmaceutical product, this is
why it should be validated to safeguard the consistent production of high-quality
water. In the pharmaceutical industry, the quality of water used in production of
finished products is the most important thing to consider. It is pivotal in
intermediate reagent preparation, analytical processes, especially in case of
parenteral products where quality of water must be as per Pharmacopoeia.
The quality of the pharmaceutical water system should fulfill all the regulatory
requirements. It can’t be denied that any laxity in proper monitoring of the water
system can be a cost burden on your manufacturing firm as it will lead to product
recall, waste of time and money. Water system validation is essential to get the
knowledge of all the physical, chemical, engineering and microbiology issues related
to water production and distribution.
Why is water system validation needed?
- It is important that the quality of water should be specific for product quality. Low quality of water can lead to product degradation, contamination, loss of product and profit.
- Usually, water contains organic and inorganic impurities, microbial contamination, endotoxin, particulate contamination which can be inappropriate for manufacturing of pharmaceutical products. Moreover, it can have a drastic impact on a product’s quality and efficiency.
- Water is a critical component in manufacturing of pharmaceutical products. Even the distribution process can also lead to contamination. This is why water system validation is an important aspect of manufacturing plants in the pharmaceutical industry.
- It is mandatory for factories to ensure water system validation for regulatory compliance.
- To prevent unacceptable microbial, chemical and physical contamination during production, storage and distribution.
Grades of water for pharmaceutical Purpose
- Potable water
- Purified water
- Water for Injection (WFI)
- Sterile water for injection and inhalation
- Sterile bacteriostatic water for injection
Conditions for water system validation in pharma
- It must maintain compliance with pharmacopoeia requirements.
- A proper sampling system from correct points with appropriate frequency.
- Detecting and resolving common contamination problems.
- To consistently produce water appropriate for industry standards for quality.