Personnel and specialists from QA, QC and Regulatory Affairs departments in the API and pharmaceutical industry
Personnel from contract development and manufacturing organisations
Representatives of EU inspectorates and regulatory authorities
Stability Testing for Drug Substances and Drug Products:
Personnel and specialists from QA, QC and Regulatory Affairs departments in the API and pharmaceutical industry
Personnel from contract development and manufacturing organisations
Representatives of EU inspectorates and regulatory authorities
Objectives
Setting Specifications and Acceptance Criteria:
In the development of new pharmaceutical products, it is a great challenge to establish meaningful and reasonable specifications, which are scientifically sound and appropriate for APIs (chemical and biological drug substances), excipients and drug products.
This course covers all aspects of specifications for Active Pharmaceutical Ingredients (APIs = Drug Substances), biological substances and pharmaceutical drug products from an analytical and a registration perspective.
In the workshops the participants will elaborate specifications
for drug substance and drug product based on different case studies,
specifications of biotechnological drug substances / drug products – general part
specifications of biotechnological drug substances / drug products – related to the impurity profiles
These example specifications will be useful “take home messages” which will help the participants to define or to evaluate specifications in their daily work.
Stability Testing for Drug Substances and Drug Products:
Analytical methods that were not “stability-indicating” are frequently cited in FDA 483s and Warning Letters. This course will thus address how to set impurity limits for related substances and degradation products based on method capability and stability results.
This course is intended to provide information on different aspects of stability testing. The course will be opened by an overview of stability testing with a special focus on the ICH Guidelines. In the subsequent presentation, important aspects of stability testing for biologicals and throughout drug development are discussed. Another lecture focuses on stability testing for Drug Substances, followed by a talk on Drug Products. In a further presentation, the focus lies on the various aspects of submitting stability data. Finally, statistical considerations will be covered in another lecture.
Programme
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
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
Specifications of Biopharmaceuticals
Overview of regulatory requirements
Critical Quality attributes and Control Strategy
Differences between NCEs and NBEs
Considerations for Drug Substance and Drug Product
Specifications during early and late stage development
Acceptance criteria at release and for shelf-life
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
Setting Specifications throughout Drug Development
Specifications throughout development
Specifications in Pharmacopoeias
Stability of the manufacturing process
Specifications for comparator products
Setting Specifications in the CTD
Total Control Strategy and Regulatory Background
Drug Substances, Excipients and Drug Products
Packaging materials
Which information should be included in the CTD
Typical questions from authorities and answers
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)
Parallel Session A (Lectures and Workshops)
CHEMICAL APIs Group I: APIs Manufactured by Chemical Synthesis
Lecture and Workshop Rational Development and Justification of API Specfications
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 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
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: productrelated 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
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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 cctivities
Stability Testing for Biologicals
Overview of regulatory requirements
Types of stability studies for Biopharmaceuticals
Practical aspects of stability studies with Biopharmaceuticals
Degradation pathways
Setting shelf-life during early and late stage development
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
Regulatory Strategy Stability
Drug Substance and Drug Product Stability Data and Evaluation
Storage recommendations/labelling/SmPC
Stability studies, commitments post approval
Typical questions from authorities and answers
Evaluation of Stability Results – Statistical Considerations
Sample number and replication
Trend analysis
Outliers
Pooling of batch data
Shelf-life prediction
Further Information
Venue Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona Spain +34 (93) 503 53 00 sants@barcelo.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) Non-ECA Members € 2,990 ECA Members € 2,790 APIC Members € 2,890 EU GMP Inspectorates € 1,495 The conference fee is payable in advance after receipt of invoice and includes lunch and dinner on the first and second day, lunch on the third day and all refreshments. VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Setting Specifications and Acceptance Criteria: Tue, 03 Nov 2026, 09:00-18:00 h (Registration and coffee 08:30-09:00 h) Wed, 04 Nov 2026, 08:30-14:00 h (Lunch from 13:00-14:00 h)
Stability Testing for Drug Substances and Drug Products: Wed, 04 Nov 2026, 14:00-18:00 h (Registration and snack 13:30-14:00 h) Thu, 05 Nov 2026, 08:30-15:00 h
Testimonials
