While logs for cleaning and maintenance of laboratory equipment are important, equipment use logs are also critical in maintaining quality lab controls. According to 21 CFR 211.182, these use logs must contain the date, time, product, and lot number of each batch processed. These use logs must also be kept in chronological order.
A company recently received this 483 observation:
ā¦.. Written records of major equipment use are not included in individual equipment logs.
Specifically, you do not maintain equipment use logs for any of your laboratory instruments, including either of your HPLC instruments, your auto-titrator instrument, your Fourier Transform Infrared (FTIR) instrument, your laboratory scales, your pH meter, your viscometer, or your microbiological incubators.
As demonstrated in the observation above, these logs apply to large laboratory machines all the way down to simple laboratory utensils. The only exception to this rule occurs if the equipment is dedicated to one single product, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. Failure to maintain such equipment records could result in an observation.
For more observationsĀ pertaining to lab controls, seeĀ Issue 1041.Ā It also has observations pertaining to manufacturing controls, packaging and labelingĀ and medical device manufacturers.
Stay in Compliance!Ā SubscribeĀ today!
Recent Comments