What is validation?

The choice of equipment in a laboratory or pharmaceutical testing facility can be crucial to the success or failure of the trials being carried.

Biotechnology, pharmaceutical and testing laboratories must carry out specific tests to demonstrate compliance for every instrument, software program and measurement technique. Agencies controlling the licensing of manufacture for many pharmaceutical and medical products set out strict guidelines that must be consistently met.

An effective validation system includes the ingredients, processes and equipment used at every step of manufacture. From batch to batch, standards must remain high at all times and documentation must exist to prove this. Validation exists to demonstrate safety at every level.

Delivering guaranteed water quality and continual performance data, PURELAB Chorus helps you with many aspects of your validation requirements. This includes installation qualification (IQ) and operational qualification (OQ) to meet GMP targets, plus many GLP objectives.

Read our Validation is key blog.

Which PURELAB Chorus system is the best match for your lab? 

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Good Manufacturing Practice (GMP)

All laboratories must provide documentary evidence to confirm that manufactured products are fit for the intended purpose. This requirement forms part of the quality assurance program for all biotechnology and pharmaceutical manufacturers.

Every step of the process must be verified. Equipment that records hour to hour performance data provides invaluable support for your validation process.

For GMP, consistency is key. PURELAB Chorus never deviates from the standard set, delivering the exact quality of purified water specified every time.

Installation Qualification (IQ) is one aspect of GMP where Chorus will help. You’ll hold documentation to confirm your water purification system has been installed and commissioned to the approved design specification. Meanwhile, Operational Qualification (OQ) of Chorus can also be achieved with ease. We’ll show you how to demonstrate the system is operating consistently within the specified limits set.

Good Laboratory Practice (GLP)

GLPs concerns pre-clinical or non-clinical studies that support laboratory work performed in test systems for applications such as biocompatibility, toxicology, or pharmacology. This might include live organisms, plants, or microorganisms. GLP provides the MHRA with the data required to audit the scientific validity of research studies such as these.

Once again, Chorus provides plenty of data support when it comes to completing GLP validation and complying with your standard operating procedures (SOPs). Just like GMP, GLP must demonstrate consistency, reliability, and reproducibility.

PureSure technology, coupled with regular recirculation delivers performance data to show the consistent high quality of your purified water. Choosing equipment that supports your validation in this way helps to maintain your laboratory’s standards, day in, day out.


 

Would you like to find out more about how PURELAB Chorus can assist with your validation?

Speak to one of our experts today

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