Re-validation of Purified Water System : Pharmaceutical Guidelines

Re-validation of Purified Water System

Purified water system is a critical system in pharmaceutical industry. Re-validation of water system is mandatory after any change in system to maintain the product quality.
Water is a critical ingredient widely used in the pharmaceutical industry for the processing, formulation, and production of pharmaceuticals. Due to an increase of micro-organisms in water during distribution, purification and storage; constant control of microbiological quality, inorganic and organic impurities in water are critical.

Most of the water used for pharmaceutical purposes may vary in grade but is usually an extract of either drinking or comparable grade water hence water systems in the pharmaceutical industry must be constantly validated to ensure a continuous production of high-quality water.


Revalidation of purified water systems is an essential part of the validation process. It increases the smoothness of the process while ensuring high-quality production of water. Revalidation is crucial and can occur due to various conditions.
A. Periodic revalidation
B. Revalidation after any change

A. Periodic Revalidation: Over a period of time, there is bound to be a change in the way a system works. Periodic revalidation is done to detect this changes. Specific areas to be addressed during periodic revalidation of a purified water system include; standard operating procedure, specification, analytical method, calibration etc.

B. Revalidation after any Change: Changes in a purified water system is a phenomenon that cannot be predicted. A simple system breakdown, major dent, an accident etc. can lead to a major overhaul of systems. This means tampering with the coordination which automatically adds contaminations. This is where revalidation comes in. it should be done after any change that affects product/system quality. Perceptible changes include:
1. Change in the procedure due to a revolution in technology.
2. Any physical change in process equipment i.e. change of a manual system to an automatic system.
3. Change in utility used or production system as a major change.
4. Any maintenance work due to the breakdown in the purified water production or distribution system.
5. Expansion of the distribution system and the addition of new user point(s).
Related: How to Remove Pathogens from Water Systems

Unlike validation, revalidation requires less or no time for monitoring and observation. Instead, after any major change revalidation should commence immediately considering the sensitivity of the pharmaceutical industry. Products manufactured in this industries affect all people in their day to day lives. They will be distributed to hospitals, emergency situations, food industry etc.
Related: Biofilm and Its Formation in Water System

A good revalidation process is dependent on the initial validation and how it planned to redress various changes in the system. The preliminary validation process should be robust enough to give a clear difference between a major and a minor change. There should be clear guidelines on when a minor or major change affects the water quality or the overall operation of the system.

Revalidation is not necessary when any equipment is upgraded to a newer version or is replaced with the same type of equipment.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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1 comment: Post Yours! Read Comment Policy ▼

  1. Greetings. If any water system distribution line expand the loop/sub-loop and add a new user point on that sub-loop, is it mandatory to validate the whole system (three phase) again? would you please share any guideline reference for this?

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