Setting Specifications and Acceptance Criteria AND Stability Testing for Drug Substances and Drug Products Save EUR 400,- and book both Conferences!

Setting Specifications and Acceptance Criteria AND Stability Testing for Drug Substances and Drug Products Save EUR 400,- and book both Conferences!

Barcelona, Spain

Course No 15486


Costs

This conference already took place.

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

Speakers

Setting Specifications and Acceptance Criteria

Dr Thomas Fürst, Boehringer Ingelheim Pharma, Germany

Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany

Dr Cornelia Nopitsch-Mai, Bonn, Germany

Dr Bettina Pahlen, Quality x Pharma Consulting GmbH, Germany

Dr Thomas Uhlich, Bayer Pharma, Germany


Stability Testing for Drug Substances and Drug Products

Dr Thomas Fürst, Boehringer Ingelheim Pharma, Germany

Dr Wolfgang Grimm, Germany

Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany

Dr Jordi Ruiz-Combalia, Audit GMP, Spain

Dr Thomas Uhlich, Bayer Pharma

Programme

Setting Specifications and Acceptance Criteria

Part I –
Regulatory Requirements and Setting Specifcations 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

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 tracking
Toxicological qualification
Genotoxic impurities
Control of genotoxic impurities

Part II – Chemical APIs and Biopharmaceutical Drug Development Parallel Session A (Lectures and Workshops)

CHEMICAL APIs
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.

BIOLOGICALS
Group II:
Drug Substances / Drug Products Manufactured by Biotechnological Processes – Part 1
Lecture and Workshop
Setting Specifications during Biopharmaceutical Drug Development (with a special focus on Monoclonal Antibodies) – an introduction
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.

BIOLOGICALS
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?
Packaging material: Which information should be included in the CTD?
What needs to be considered in a global environment?
What are the typical questions?


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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