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US 9,195,228 B2Granted
Monitoring pharmaceutical manufacturing processes
AssigneeSMP Logic Systems LLC
InventorShane M. Popp
Life of this patent
Estimating the term…
Abstract
Methods of monitoring data generated by a device adapted for use in a pharmaceutical manufacturing environment are described and disclosed herein. The method creates a historic record of the pharmaceutical manufacturing process and provides it to an end user or a plurality of end users. Consequently, the methods provide a means to track the frequency of hazards associated with said device and thereby perform quality control on an integrated level whereby a pharmaceutical manufacturer can ensure data and product integrity and minimize cost.
Claims19
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.
1 more element
Dependencies are inferred from the claim text.