Investigations in Pharmaceutical Water Systems

nvestigations in pharmaceutical water systems are very critical for pharmaceutical organizations and laboratories. They can mean the difference between compliance and noncompliance. In many cases, organizations can get hauled up by regulatory authorities for failing to carry out proper investigations into pharmaceutical water systems.

The most common problem encountered by pharmaceutical and biotech companies and laboratories is microbial excursions. Investigating and handling excursions is the key to success in pharmaceutical water systems investigations.

Understanding excursions

So, what are water systems microbial excursions, and why do they appear so intimidating? In the simplest terms, microbial excursions may be defined as environmental data that is at par with or above established action limits for the regulated area. This means that in samples of water that fail to pass excursion tests, there is a certain level of contamination of the water systems in pharmaceutical and biotech organizations. Of course, it has to be borne in mind that the purity expectations and requirements are quite high compared to the water normally used by humans.

Why this is so is that pharmaceutical water systems are those that are used in the manufacture of drugs and pharmaceuticals; hence, even a small deviation from the prescribed levels of purity can have a major impact on the final outcome –the drug quality.

What can be done about excursions, then?

Having said this, excursions are not necessarily evil. Understanding whether excursions are from water, soil or from humans gives a good indication of the nature of excursions, which in turn give researchers a good idea of the nature of problems in the environment around them.

In many cases, wrongly designated trigger values, use points or wrongly selected and executed sampling and testing –and seldom excursions in themselves –are the culprit. So, pharmaceutical water systems and biotechnology organizations, laboratories and utility operations need to get their sampling right if they have to get to the root of the problem. This will help them avoid the huge costs associated with wrongly carried out investigations into pharmaceutical water systems.






Author: GlobalCompliancePanel-Training

GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

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