USP 841 Relative Density lab controls

USP 841 Relative Density lab controlsSOP for the measurement of density or specific gravity by Quality Control by weighing a sample in a glass or stainless steel Pycnometer of a known volume and comparing to purified water

contact surfaces

You must keep written records required by this part for 1 year past the shelf life date

Quality control personnel must ensure that your manufacturing

change controls

or absorptive

You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies

and must be tested or examined to determine whether the batch meets its established specifications of identity

the lot and any other implicated lots must be quarantined and an out of specification (OOS) investigation conducted to determine the validity of the result

then stored without mix-up or contamination

and contact surfaces you must take measures to exclude from any operations any person who in the opinion of a supervisor appears to have a health condition such as illness

The outsourced activity must be appropriately defined

This applies to physical