Source: http://www.google.fr/patents/US8591811
Timestamp: 2017-12-17 14:07:59
Document Index: 87003468

Matched Legal Cases: ['Art 25', 'Art. 26', 'Art. 26', 'art 11', 'art 11', 'art 4']

Brevet US8591811 - Monitoring acceptance criteria of pharmaceutical manufacturing processes - Google Brevets
Methods of monitoring acceptance criteria of pharmaceutical manufacturing processes are disclosed herein. The methods described herein provide an ability to control and monitor pharmaceutical manufacturing processes (for example, finishing and packaging of pharmaceuticals) and can ensure data and product...http://www.google.fr/patents/US8591811?utm_source=gb-gplus-shareBrevet US8591811 - Monitoring acceptance criteria of pharmaceutical manufacturing processes
Numéro de publication US8591811 B2
Numéro de demande US 13/815,713
Date de dépôt 18 mars 2013
Autre référence de publication US7379783, US7379784, US7799273, US8491839, US9092028, US9304509, US20070021856, US20070032897, US20080038833, US20100256816, US20130218317, US20140094949, US20150309505
Numéro de publication 13815713, 815713, US 8591811 B2, US 8591811B2, US-B2-8591811, US8591811 B2, US8591811B2
Cessionnaire d'origine Smp Logic Systems Llc
Citations de brevets (399), Citations hors brevets (73), Référencé par (3), Classifications (23), Événements juridiques (3)
US 8591811 B2
Methods of monitoring acceptance criteria of pharmaceutical manufacturing processes are disclosed herein. The methods described herein provide an ability to control and monitor pharmaceutical manufacturing processes (for example, finishing and packaging of pharmaceuticals) and can ensure data and product integrity and ultimately minimize overall manufacturing cost.
1. A method of monitoring an acceptance criteria of a pharmaceutical manufacturing system said method comprising,
a) monitoring data generated by a pharmaceutical manufacturing system during pharmaceutical manufacture, wherein said pharmaceutical manufacture produces an active ingredient;
2. The method of claim 1, wherein the monitoring is part of a quality assurance protocol.
3. The method of claim 1, wherein the historical record comprises a time stamped audit trail.
4. The method of claim 1, wherein the pharmaceutical manufacturing system uses at least a mixing tank and a time-stamped audit trail.
5. The method of claim 1, wherein said monitoring is at initial process.
6. The method of claim 1, wherein said monitoring is at end process.
a) monitoring data generated by a pharmaceutical finishing and packaging system, wherein said finishing and packaging 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.
8. The method of claim 7, wherein said finishing and packaging system comprises a labeler.
9. The method of claim 7, wherein said finishing and packaging system comprises filling equipment.
10. The method of claim 7, wherein said finishing and packaging system comprises a vision inspection system.
11. The method of claim 7, wherein said finishing and packaging system comprises a capping machine.
12. The method of claim 7, wherein said historic record is maintained in a SQL database.
13. The method of claim 7, wherein said monitoring is continuous.
14. The method of claim 7, wherein said quality assurance determination is based on a quality assurance protocol.
This application is a continuation of U.S. Ser. No. 12/799,097 filed 15 Apr. 2010, which is a continuation of U.S. Ser. No. 11/503,767 filed 14 Aug. 2006, now U.S. Pat. No. 7,799,273 issued on 21 Sep. 2010, which is a continuation-in-part of U.S. Ser. No. 11/500,642, filed 8 Aug. 2006, now U.S. Pat. No. 7,471,991 issued on 30 Dec. 2008, which is a continuation of U.S. Ser. No. 10/840,732, filed 6 May 2004, now U.S. Pat. No. 7,444,197 issued on 28 Oct. 2008. The contents of which are fully incorporated by reference.
The invention further comprises a manufacturing execution system, which controls the pharmaceutical manufacturing process and increases productivity and improve's quality of pharmaceuticals.
“blueprint” means a detailed plan or outline.
The invention comprises a program and method integrated into a comprehensive cost-saving pharmaceutical manufacturing system involving multiple product lines. the system is integrated as described in Example 6 (e.g. Drug X). The system is integrated on a plurality of products (e.g. Drug Y, Drug Z, etc.). The data record is kept for each product and analyzed individually for that product. Process parameters that are identical for each product are cumulated to create a comprehensive database on the manufacturing system at-large. The system achieves greater process integrity and quality control as a result of the cumulation. The maximization of process integrity and quality provides for a cost-savings over time.
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Classification aux États-Unis 422/67, 436/180, 700/109, 700/110, 422/65, 700/26, 422/64, 422/66
Classification coopérative Y02P90/86, G05B2219/31277, Y02P90/22, Y02P90/20, Y02P90/18, Y02P90/30, G05B2219/32177, G06Q10/06, G06Q50/04, Y10T436/2575, G05B2219/11, G05B2219/1112, G05B19/41875, G05B23/0224
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