Bioequivalence and Bioavailability Forum

Dear Ramesh,

❝ i mean to say if u consider a batch of 120 samples and the extraction

❝ procedure includes 8 steps. if first four steps are done by one analyst

❝ and remaining four steps by the other.

❝

❝ whether this type of processing is acceptable or not

Why not ? I can't see any reason why it would not be possible, as long as each of the two analysts knows what he has to do himself and what has/will be done by the other, and each analyst documents what he does. And as mentioned in this post I prefer to see samples processed that way rather than have each analyst do the 8 steps for 60 samples each, and then all these samples grouped into one single run for chromatography.

❝ In a GLP lab is it necessary to use the instrument usage log books.

❝ for example use of the refrigerator centrifuge and the SPE is it necessary

❝ to have a log book refering the usage of the instrument i.e start and end

❝ of the usage of the instrument.

IMHO no. You could just document in the study-specific documentation what equipment or instruments were used (which makes the review of the documentation much easier for QC and QA than having to go through 10 different logbooks). Unless you have an instrument that requires some maintenance after a pre-defined number of uses, rather than a specific time interval.

Regards
Ohlbe