Production units of a pharmaceutical production process
Pharma Manufaturing Process Overview
Die kontinuierliche Produktion wird in der pharmazeutischen Industrie immer beliebter. Warum spielt MES hier eine entscheidende Rolle?
MES ist ein Schlüsselsystem, um die Vorteile der kontinuierlichen Produktion wie höhere Effizienz, verbesserte Produktqualität und geringere Kosten voll auszuschöpfen. Es schafft die notwenidge Transparaenz, Kontrolle und Anpassungsfähigkeit, um die komplexen Anforderungen moderner Prosuktionsprozesse in der pharmazeutischen Industrie zu erfüllen.
API Manucafturing Process
Tablet Manucaturing Process
(Four different ways)
Capsule Manufacturing Process
Sterile Manufacturing Process
Packaging Process
Process Overview of a Biotech Manufacturing Process
Main differences between pharmaceutical and biotechnology products
Regulations in Product Life Cycle
What are the important standards?
System Landscape in Life Sciences
System Landscape in Life Sciences - Description of Level 5
System Landscape in Life Sciences - Description of Level 3
System Landscape in Life Sciences - Description of Level 4
System Landscape in Life Sciences - Description of Level 0-2
Manufacturing systems - ERP
Definition
core business procecesses
most common providors
Serialization
Providors
EU FMD Product Flow Overview
Data Historian
What does LIMS stand for?
Laboratory Information Management
What are the benefity of LIMS? What are the main providors?
System Integration in Industry X.0
How is quality ensured in Life Sciences?
What is validation good for?
How are validation processes implemented across the development life cycle?
Computer System Validation (CSV)
What does it ensure?
Why is CSV a continuous challenge for life science companies?
V-Model in CSV
What are possible Outputs of Manufacturing?
What is MES? What are the main providers?
What is MES good for?
With what is MES often integrated?
What if a company doesn´t have MES?
MES Application Vendors
Werum Körber Solutions -> PAS-X
Rockwell Automation -> PharmaSuite
Siemens -> Siemens Simatic, Siemens Opcenter Execution Pharma, Siemens Opcenter Execution Medical Device & Diagnostics, Camstar
Emerson -> Syncade
POMS -> POMS net
What are the benefits of MES? (6)
MES Integration with ERP
MES Modules
How is the material management controlled by MES?
How does it look like in MES when the weighing process is started? How does it look like if the tolerance limits are reached?
What is the Master Batch record? What should an MBR include?
What is the role of MES regarding the Master Batch Records?
How are MBR structures defined and displayed?
What can MBR designers set up?
What has to be ensured regarding MES relevant phases and the MES software?
Material Flow Management
How is equipment/ object management ensured? How does it look in MES?
What are state diagrams in the pharma and biotech industry mainly?
What configurations of the state diagrams are possible?
What is the MES Market Landscape?
What does WMS stand for? What does it support?
What is in a fully automated environment the case (regarding the automation interface)?
Waht is MES able to do in this scenario?
Why is it easy to track process parameters in one system in this scenario?
What does Electronic Batch Record mean? What does it ensure? What does the system capture?
What information from an EBR are filled out by scanning? Are part of a plausibility check? Are from Automation Layer?
What has the operator to do if if she or he enters an expected barcode manually?
What is the advantage of an Electronic Batch Record?
What is the manufacturing landscape (based on ISA S95)?
What are CQA?
What are CPP?
What are Production Activities?
What is computer system validation?
Why is computer system validation needed?
What standards/ regulations play a role in context of CSV?
Computer System Validation Process
CSV - conclusion
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