“Laboratory Log Book” for samples
Clifford Nilsen replies on Pharmaceutical Formulation & Quality Magazine June/July 2005.
There should be a hard-bound log book for signing samples into the laboratory. The entries should include date, name and lot umber of sample, packaging size and signature of the submitter. Some log books even include the names of tests that are required. When a sample has been completed and the results published, an entry should be made in the log book stating the date completed and initiated by a laboratory analyst or supervisor.
Log books are very important and are always examined by auditors, particularly during FDA inspections. A sample log book is an excellent way to verify sequencing, to see if a sample was signed in before it was tested and was released after testing was completed.
From a broader manufacturing standpoint, the log book can show that the samples were taken after manufacture of product or that a raw material was tested prior of being used to manufacture the product.