Master Industrial Pharmacy

In the master’s thesis, the student must show that he/she/d can work independently on a scientific topic related to the M. Sc. Industrial Pharmacy study program over a more extended period (six months). The topic can come from fields related to the modules of the study program. The thesis needs to fulfill the standards of good scientific practice. 

• Physicochemical characterization of APIs: particle size, solubility, in-trinsic dissolution, analytical characterization
• Particle engineering, milling, amorphisation
• Function of pharmaceutical excipients: Preservatives, antioxidants, co-solvents, detergents etc.
• Drug dosage forms: Powders, granules, tablets, capsules, liquids, injections, infusions, ointments, eye and nose drops etc.
• Characterization of drug dosage forms
• Packaging requirements, materials, methods
• Quality by design (QbD) concept, critical quality attributes (CQAs), critical process parameters (CPPs)
   

• Principles of batch and continuous manufacturing
• Preparation of water with pharmaceutical quality
• Liquid and semisolid forms: solutions, emulsions, suspensions, ointments, creams, gels
• Focus on secondary manufacturing solid dosage forms: granules, pellets, different types of tablets, capsules
• Sterile product manufacturing, zone concepts
• Packaging and labeling
   

• EudraLex Vol 4
  • Chapter 1 - Pharmaceutical Quality System
  • Chapter 7 - Outsourced activities
  • Chapter 9 - Self Inspection
  • Annex 16: Certification by a Qualified Person and Batch Release
• ICH Q9 Quality Risk Management
• ICH Q10 Pharmaceutical Quality System
• The basic structure of a pharmaceutical QMS
• Structure and use of a GMP matrix
• Key QMS documents like
  • Site Master File (SMF)
  • Validation Master Plan (VMP)
  • Standard Operating Procedures (SOPs)
  • Corrective Actions and Preventive Actions (CAPA)
  • Change Control
  • Deviations
• Batch release by a qualified person or quality unit
• Audits and inspections
   

• Definition and responsibilities of drug regulatory affairs
• Global authorization of medicines
• Common Technical Documents (CTD)
• INDs and NDAs
• Modules for marketing authorizations
• Writing Paediatric Investigation Plans (PIPs)
• Writing Investigational Medicinal Product Dossier (IMPD)
• Writing Investigator Brochure (IB)
• Marketing Authorization (MA) strategies
• MA structure, writing and submission
• Pharmacovigilance
   

• Primary manufacturing of APIs
• Scale-up principles
• Economic analysis
• Integrated theoretical and practical learning in continuous manufacturing principles: case study solid dosage forms
• Process Analytical Technologies (PAT): process data, spectroscopic techniques, other probes, data treatment
• Pharmaceutical process control: feed forward and feed backward controllers, design and evaluation of control systems, real-time monitoring, integration of unit operations, flowsheet modeling, implementation of control system and closed-loop operation

• Mathematical PK modelling and profiling
• Drug dissolution methods
• Mechanisms of drug absorption and excretion
• Drug administration sites and permeation pathways
• In-vitro permeation models
• PK/PD (pharmacokinetics/pharmacodynamics) modelling
• Physiology-based PK modelling (PBPK)
• Patient-specific PK profiling
• Dose optimisation
• Bioavailability (BA), relative BA
• Bioequivalence (BE), data evaluation
• Design and evaluation of BA and BE studies

• Samples and populations
• Statistical hypothesis testing and confidence intervals
• Correlation, regression and clustering
• Design of experiments (full factorial designs, fractional factorial designs, central composite designs, mixture designs, D-optimal designs)
• Basics of multivariate data analysis (PCA, PLS)
• Introduction into statistical software: Python and/or RStudio, Modde
• Application to real-life problems (exercises)

• Regulatory background for stability testing (ICH, EMA, FDA)
• Long-term, short-term, in-use stability testing
• Experimental investigations
  • Forced (accelerated) stability testing
  • Forced degradation testing
  • Planning of stability testing
  • Reporting of stability results
• Data reporting and transfer into official documents

• Understanding of pharmaceutical approach to manufacture of medicinal products
• International drug laws (focus on Europe and USA)
• Organisation of competent authorities (EMA, BfArM, PEI, MHRA, EDQM, FDA, WHO etc.)
• Basic regulations and requirements
  Pharmacopoeias: Ph.Eur., DAB, BP, USP
• cGMP regulations and related terms
• Validation, Qualification, Justification

• Multipurpose plants
• Process flowsheet modelling
• GMP-compliant plant design
• Conceptual plant layout
• Zoning concepts
• Cleaning concepts
• Water, steam, gases
• HVAC installations
• Waste management
• Cleanroom concepts
• Qualification
• Automation
• Scheduling and Logistics

• Legal background (focus on Europe)
• Definition of medical devices (vs drugs, foodstuff etc.)
• Drug-Device Combinations EMA (Combination Products FDA)
• Distinguishing medical devices vs medicinal products, foodstuff etc.
• Development of medical devices vs medicinal products
• Examples of medical devices for
  • Parenteral delivery
  • Insulin delivery
  • Skin and wound healing
  • Fracture management, bone augmentation
  • Nasal delivery
  • Pulmonary delivery
  • Electronic drug delivery

• First-in-human, bioavailability/bioequivalence studies, phase II/III studies, post-marketing studies pharmacovigilance 
  Setup and planning of clinical studies
  Required documents
• Responsibilities and Liability
• Monitoring
• Good Clinical Practice / Good Clinical Laboratory Practice
• Producing clinical batches
  Clinical trial supply
  Reporting and storage of personal data and clinical results
  Dossier content
• Paediatric Investigation Plan (PIP)
  Investigational Medicinal Product Dossier (IMPD)
  Investigator Brochure (IB)

• Basics of project management
• Tools for project management
• Project structure plan (PSP)
• Critical path analysis/network analysis
  Trend analysis, milestone structures
• Roles in a project team
• Communication
• Stakeholder analysis
• Examples from practice
• Reporting

• IP strategies
• International patent regulations
• Patent structure and content
• Patent language
• Alternatives to protection by patents
• Examples of pharmaceutical patents and strategies
• Patents for blockbusters
• Patents for rare diseases
• Life-cycle management by patent filing
• Patent leaks
• Patent defeats and referrals

• Business models for the pharma industry
• Strategic planning and business optimization
• Life-cyle management
• Basic accounting rules
• Efficient reporting
• Outsourcing in the pharmaceutical industry: view from MA holders and contract manufacturers
• International Business Skills
• Cultural Differences / Intercultural Training
• Human Resources / Job Applications in Industry
• Pharma 4.0
• Examples of various company models

• Overview of continuous chemical unit operations (reactors, workup, crystallization, washing, DS drying)
• Coupling techniques and discussion thereof
• End-to-end (E2E) continuous manufacturing
• Alternative (non-OSD) CM technologies
• Material diversion strategies
• PAT techniques in the field of CM
• Advanced process management with special emphasis on continuous pharmaceutical processes
• Understanding of process characterization aspects and techniques to manage portfolios of processes in industrial settings
• System dynamics of CM process trains and their detection
• Regulatory expectations (ICH Q13) and ways to address them
• Quality management in CM processes (discretized vs continuous processes)