Setting Specifications AND Stability Testing

Setting Specifications AND Stability Testing

Prague, Czech Republic

Course No 17381


ECA-Member: EUR 2380,--
Non ECA Member: EUR 2780,--
EU/GMP Inspectorates: EUR 1390,--
APIC Member Discount: EUR 2580,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Dr Thomas Fürst, Boehringer Ingelheim , Germany
Dr Wolfgang Grimm, Germany
Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Dr Cornelia Nopitsch-Mai, Quality Assessor, Germany
Dr Jordi Ruiz-Combalia, Audit GMP, Spain
Dr Bettina Pahlen, Quality x Pharma Consulting, Germany
Dr Thomas Uhlich, Bayer, Germany


Setting Specifications and Acceptance Criteria

Part I – Regulatory Requirements and Setting Specifications during the Development Phase
  • Current Regulatory Requirements for Setting Specifications (ICH Q6A)
  • Regulatory overview
  • Impact of pharmacopoeial provisions
  • Setting specifications for active substances and finished products
  • Justification of specifications
  • Changes/variations
  • Introduction to the requirements of risk assessment with focus on setting specifications  for heavy metals
  • How authorities will proceed in respect of submitting the required documentation for approved marketed products 
Current Regulatory Requirements for Specifications of Biotech Products/
Well-characterised Biologicals (ICH Q6B and other Guidelines)
  • Overview of regulatory requirements
  • Characterization of product and  establishing acceptance criteria
  • Analytical aspects including method validation
  • Setting up specifications – principles to consider
  • New approaches: Design Space for a Biotechnological Product –  ICH Q11  requirements
Basic Principles for Setting of Release and Shelf-life Specifications
  • Some basic statistics: Distribution and Variation
  • Variation and specifications
  • Changes over time and shelf life specification
  • Process Capability
  • Control strategy
  • QbD or not to be
Organic Impurities and Degradation Products with Special Emphasis on Genotoxic Impurities
  • What do the guidelines tell us
  • Impurity identification and profiling
  • Impurity tracking1
  • Toxicological qualification
  • Genotoxic impurities
  • Control of genotoxic impurities
Part II – Chemical APIs and Biopharmaceutical Drug Development Parallel Session A (Lectures and Workshops)

Group I: APIs Manufactured by Chemical Synthesis
Lecture and Workshop
Rational Development and Justification of API  Specifications
  • In this workshop participants will elaborate specifications comprising typical tests for APIs
  • Assay, organic impurities and degradation products, water, residual solvents,
  • heavy metals, particle size distribution, polymorphs, genotoxic impurities etc.

Group II: Drug Substances / Drug Products Manufactured by Biotechnological

Processes – Part 1
Lecture and Workshop
Setting Specifications in early  Biopharmaceutical Drug Development (with a special focus on Monoclonal Antibodies)
  • General overview of manufacturing processes for biopharmaceuticals and process control
  • Analytical testing scope for biopharmaceuticals
  • How to set specifications: principles to consider and justification
  • Group Work
Part III – Specific Considerations during Development and for Specfic Dosage Forms

Setting Specifications throughout Drug Development
  • Specifications throughout development
  • Specifications in Pharmacopoeias
  • Stability of the manufacturing process
  • Specifications for comparator products
Specifications for Specific Drug Products – What is the Difference to Standard Formulations
  • Specific aspects required for special drug products, e.g. Gastro-intestinal therapeutic systems (GITS) or osmotic-controlled release oral delivery systems (OROS)
  • Transdermal patches
  • Orally inhaled and nasal drug products (OINDPs)
Part IV – Drug Products and Biological Impurities
Parallel Session B (Lectures and Workshops)

DRUG PRODUCTS                                                                   
Group I: Drug Products Containing APIs (manufactured by chemical synthesis)

Lecture and Workshop
Rational Development and Justification of Drug Products Specifications
In this workshop participants will elaborate specifications comprising typical tests for
different types of drug products:  e.g. assay, purity, content uniformity, dissolution, fill volume, endotoxines, sterility etc.

Group II: Drug Substances / Drug Products Manufactured by Biotechnological Processes – Part 2

Lecture and Workshop
Impurities in Biological Drug Substances and Drug Products (with a special focus on Monoclonal Antibodies)
  • Impurities from chemical synthesis versus biotechnological process
  • Definition of impurities and their classification: product-related impurities, process-related impurities, contaminants and identification of possible degradation products
  • How to deal with impurities in biological drug substances and drug products
  • Analytical techniques and other aspects
  • Group work
Part V –  Excipients and Container Closure Systems

Specifications for Excipients and Container Closure Systems (EU/US)
  • Excipients in the CTD: What needs to be considered for setting specs in the CTD?
  • Excipients: What is new and important for you (functionality testing, GMP for excipients)
  • Packaging material: Which information should be included in the CTD?
  • What needs to be considered in a global environment?
  • What are the typical questions from Authorities? 
Stability Testing for Drug Substances and Drug Products

Current ICH and CHMP Guidelines for Stability Testing
  • Overview of stability guidelines
  • Concepts of stability testing
  • Retest period and shelf-life
  • Post-marketing stability studies
  • Future activities
Stability Testing throughout Drug Development
  • Must the development stability programme meet ICH Q1A?
  • Stability testing from early development to product launch
  • Clinical stability for comparators
  • Site specific stability
Stability Testing for Drug Substances
  • Stability protocols
  • Stress testing
  • Photostability testing
  • Documentation
Stability Testing for Drug Products
  • Strategy of stability testing
  • Performance of new drug products
  • Related finished products with existing substances
  • Follow-up stability testing
Submitting Stability Data – The CTD Structure
  • Drug substance stability
  • Drug product stability
  • Storage recommendations/labelling
  • Essential hints for writing the stability part in the CTD
Evaluation of Stability Results – Statistical Considerations
  • Sample number and replication
  • Trend analysis
  • Outliers
  • Pooling of batch data
  • Shelf life prediction
Post-marketing Stability Testing
  • Stability studies after approval (EU/US)
  • Changes with impact on stability
  • Examples

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