Water is the lifeblood of the pharmaceutical industry. It's not just a utility; it's a critical ingredient widely used for processing, formulation, and the final production of medicines. Because of this essential role, the constant quality control of this water—including microbiological levels and inorganic/organic impurities—is absolutely crucial for patient safety and product efficacy.
Most pharmaceutical water starts as drinking or comparable grade water. This is why water systems in the pharmaceutical industry must be rigorously and continuously validated to ensure a consistent, high-quality output that meets cGMP (current Good Manufacturing Practice) standards.
Why is Purified Water System Revalidation Mandatory?
Revalidation is an indispensable part of maintaining a compliant purified water system. It goes beyond the initial system setup to proactively increase the smoothness and reliability of your process, ensuring the continuous production of high-quality water.
A simple fact is that any change—whether planned or unexpected—can introduce contamination or compromise the system's performance. For this reason, revalidation of purified water systems is mandated under two primary conditions:
A. Periodic Revalidation: Detecting Inevitable Change
Over time, even a perfectly maintained system will experience subtle operational shifts. Periodic revalidation is a scheduled process designed to detect these gradual changes before they affect product quality.
During a periodic revalidation of a purified water system, specific areas that must be thoroughly reviewed and updated include:
- Standard Operating Procedures (SOPs)
- System Specifications and Performance Criteria
- Analytical Methods used for testing
- Calibration records and status
B. Revalidation After Any System Change: Immediate Action
Unforeseen events like a major dent, a simple system breakdown, or even planned physical changes demand immediate attention. Any modification that affects the system's coordination can automatically introduce contamination, requiring an urgent re-evaluation.
Revalidation after any change should commence immediately, given the sensitivity of the pharmaceutical environment.
Perceptible changes that require revalidation include:
- Change in the procedure due to an upgrade or revolution in technology.
- Any physical change in process equipment (e.g., converting a manual system to an automatic system).
- Major changes in the utility used or the core production system.
- Any maintenance work following a breakdown in the water production or distribution system.
- Expansion of the distribution system and the addition of new user point(s).
A Crucial Exception: Revalidation is typically not necessary when any equipment is merely upgraded to a newer version or is replaced with the exact same type of equipment. This is usually managed through the system's change control procedure.
The Role of Initial Validation in Revalidation Success
A robust revalidation process heavily depends on how thoroughly the initial validation was performed. The preliminary validation must be comprehensive enough to establish clear, documented guidelines that distinguish between a major and a minor change.
Clear guidelines must exist on when a minor or major change is likely to affect the industrial water quality or the overall operation of the system, enabling pharmaceutical companies to make the correct, compliant decision on whether to revalidate.
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