Setting Specifications AND Stability Testing - Live Online Training
11-13 November 2025
Course No. 22027
Speakers
Dr. Thomas Fürst
Boehringer Ingelheim
Dr. Bettina Pahlen
Quality x Pharma Consulting
Dr. Josef Hofer
exdra
Dr. Cornelia Nopitsch-Mai
formerly Quality Assessor
Dr Thomas Uhlich
Bayer
Dr Ulli Backofen
Boehringer Ingelheim
All times mentioned are CET.
Objectives
Objectives Setting Specifications
This Live Online Training 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.
Objectives Stability Testing for Drug Products This Live Online Training 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 presentations, 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 to the various aspects of submitting stability data. Finally, statistical considerations will be covered in another lecture.
Background
Background Setting Specifications
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. According to ICH Guideline Q6A, a specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. Learn about latest news and important aspects of excipients, such as functionality testing (EP and USP) as well as what GMP-level is requested for excipients. Concentrate on the essentials for packaging material including important information to be included in the CTD.
The analytical result, which will be compared to the specification, is affected by the variability of the measurement itself and depends also on the sampling process and on the variability of the manufacturing process of the tested product itself. This makes statistical considerations essential and consideration of the associated measurement uncertainties vital when setting or complying with specifications.
Analytical methods that were not “stability-indicating” are frequently cited in FDA 483s and Warning Letters. This conference will thus address how to set impurity limits for related substances and degradation products based on method capability and stability results. Furthermore, genotoxic impurities and strategies for their control will be presented and QbD (Quality by Design) will also be discussed.
Finally, specifications for the API (drug substance), excipient(s) and the drug product are part of the quality section of the marketing authorisation application which has to be submitted to the competent authority.
Background 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 conference will thus address how to set impurity limits for related substances and degradation products based on method capability and stability results.
The analytical result, which will be compared to the specification, is affected by the variability of the measurement itself and depends also on the sampling process and on the variability of the manufacturing process of the tested product itself. This makes statistical considerations essential and consideration of the associated measurement uncertainties vital when setting or complying with specifications.
Finally, specifications for the API (drug substance), excipient(s) and the drug product are part of the quality section of the marketing authorisation application which has to be submitted to the competent authority.
Target Group
This Live Online Training is of particular interest to specialists from QA, QC and Regulatory Affairs departments of the API and pharmaceutical industry and CROs as well as to members of the EU inspectorates and authorities. Participants have the opportunity to exchange their experiences they gained with the different aspects of ‘specifications’ with the experts from the API and pharmaceutical industry as well as with members of competent authorities.
Dates & Technical Requirements
Dates
Setting Specifications: Tuesday, 11 November 2025, 09.00 – 18.00 h CET Wednesday, 12 November 2025, 08.30 – 13.00 h CET
Stability Testing for Drug Substances and Drug Products Wednesday, 12 November 2025, 14.00 – 17.00 h CET Thursday, 13 November 2025, 09.00 – 16.30 h CET
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Part I – Regulatory Requirements and Setting Specifcations during the Development Phase
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
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 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
Part III – Specific Considerations during Development and for Specific 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
Part V – Common Technical Document (CTD)
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
*****
Programme 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 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
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
Testimonials
Seminar Programme as PDF