Setting Specifications and Acceptance Criteria

Setting Specifications and Acceptance Criteria

Barcelona, Spain

Course No 16533


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Dr Thomas Fürst, SANOFI, 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 AG, Germany


This event 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.


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.

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.

Target Group

This conference 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.


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
  • 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 tracking
  • 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

  • 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)

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?

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