8.4 - Laboratory Controls - OOS Investigation and Form culture and from accredited sources

and from accredited sources

This applies to physical

or examined

Your batch production record must accurately follow each step of the appropriate master manufacturing record

Sufficient space should be given to avoid mix-ups and cross-contamination

8.4 - Laboratory Controls - OOS Investigation and Form culture and from accredited sourcesAn out of specification investigation must be completed each time a laboratory test, examination or the result of any monitoring fails to meet an established specification; one investigation per OOS test parameter. This applies to physical, chemical, & microbiological tests or examinations, stability testing, monitoring, and validation