Page 32 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
3. Validate the cleaning process.
Validating the cleaning process would involve demonstrating under a set of
specific conditions (the approved cleaning procedure) that all contaminants
can consistently be removed. If the conditions can be reproduced usually
three times, the cleaning process can be validated.
When the process is validated. then. the company no longer has to rely on
intensive and expensive testing to prove cleanliness each lime.
What needs to be validated?
There are many things that require validation under GMP. These include:
the suitability of the manufacturing facility
the suitability of critical utilities such as gases and water
GMP-related computer systems
production equipment
equipment and facility cleaning procedures
laboratory fest methods
manufacturing and packaging processes
GOOD TO KNOW – TEST METHOD VALIDATION
The laboratory is required to demonstrate that all test methods are reliable.
This means they must be validated by verifying the following attributes:
precision (amount of variation in the assay)
accuracy (difference between the average results and the "true" value)
selectivity (ability of the method to measure the analyte in the presence of
Interfering compounds)
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