Patent ID: 9195228
Filing Date: 2015-11-24
Classification: G05B,G06Q

Abstract:
1. A method comprising, a) monitoring data compiled by a device adapted for use in a pharmaceutical manufacturing process that produces an active ingredient during pharmaceutical manufacture, wherein said active ingredient furnishes a pharmacological effect, wherein said device is located at a critical control point in said pharmaceutical manufacturing process; b) creating a historic record of the pharmaceutical manufacturing process that produces said active ingredient wherein said historic data comprises said data compiled by said device adapted for use in a pharmaceutical manufacturing processes that produce said active ingredient; c) providing the historic record to an end user; d) analyzing the data associated with the device to determine whether an acceptance criteria that relates to said active ingredient has been achieved, wherein said acceptance criteria relates to an acceptable quality level or an unacceptable quality level, necessary to accept or reject a lot or a batch of said active ingredient.