Methods for monitoring integrated continuous pharmacetical manufacturing processes

Abstract

Methods for monitoring integrated continuous pharmaceutical manufacturing processes are described and disclosed herein. The method continuously monitors and 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 perform quality control on an integrated level whereby a pharmaceutical manufacturer can ensure data and product integrity and minimize cost.

1 ) A method comprising,
 a) continuously monitoring an acceptance criteria in a pharmaceutical manufacturing process, where said pharmaceutical manufacturing process produces an active ingredient and wherein the monitoring occurs at a critical control point;   b) compiling data obtained during the monitoring of the pharmaceutical manufacturing process and storing the data in a historic record, wherein the historic record comprises a lot number, control number, or batch number;   c) analyzing the historic record to provide a comparative analysis against the acceptance criteria, wherein the analysis is performed at various times throughout the pharmaceutical manufacturing production cycle;   d) taking corrective action during the pharmaceutical manufacturing process based on a comparative analysis against the acceptance criteria, wherein said corrective action comprises modifying the pharmaceutical manufacturing process.   
     
     
         2 ) The method of  claim 1 , wherein the pharmaceutical manufacturing process is a batch pharmaceutical manufacturing process. 
     
     
         3 ) The method of  claim 1 , wherein the pharmaceutical manufacturing process utilizes a chromatography/separation system. 
     
     
         4 ) The method of  claim 1 , wherein the pharmaceutical manufacturing process utilizes a mixing tank. 
     
     
         5 ) The method of  claim 1 , wherein the pharmaceutical manufacturing process utilizes a clean-in-place system. 
     
     
         6 ) The method of  claim 1 , wherein the pharmaceutical manufacturing process utilizes a time-stamped audit trail. 
     
     
         7 ) The method of  claim 1 , wherein the acceptance criteria is predetermined by a quality control unit. 
     
     
         8 ) The method of  claim 1 , wherein the pharmaceutical manufacturing process utilizes filling equipment. 
     
     
         9 ) The method of  claim 1 , wherein the pharmaceutical manufacturing process utilizes a lyophilizer/freeze. 
     
     
         10 ) The method of  claim 1 , wherein the pharmaceutical manufacturing process utilizes a modular cleanroom. 
     
     
         11 ) A method comprising,
 a) continuously monitoring data generated by a pharmaceutical chromatography/separation system, wherein said chromatography/separation system produces a drug product;   b) maintaining the data over time to provide a historic record;   c) analyzing the historic record to provide a quality assurance determination for said drug product;   d) taking corrective action to obviate a failure against said quality assurance determination.   
     
     
         12 ) The method of  claim 11 , wherein the quality assurance determination is based on a quality assurance protocol. 
     
     
         13 ) The method of  claim 11 , wherein the historic record is maintained in a SQL database. 
     
     
         14 ) The method of  claim 11 , wherein the chromatography/separation system comprises a specialty gas system. 
     
     
         15 ) The method of  claim 11 , wherein the chromatography/separation system comprises a mixing tank. 
     
     
         16 ) The method of  claim 11 , wherein the chromatography/separation system comprises a plurality of mixing tanks. 
     
     
         17 ) The method of  claim 11 , wherein the chromatography/separation system comprises a bioreactor. 
     
     
         18 ) The method of  claim 11 , wherein the chromatography/separation system comprises a vessel. 
     
     
         19 ) The method of  claim 11 , wherein the chromatography/separation system comprises a filtration system.