API Regulatory Starting Materials

API Regulatory Starting Materials

Copenhagen, Denmark

Course No 15868


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Marieke van Dalen, AspenOss

Hiltrud Horn, Horn Pharmaceutical Consulting, Germany

Gerd Jilge, Boehringer Ingelheim, Germany

Dr Corina Nachtsheim, Quality Assessor, Germany

Matthias Schneider, BASF, Germany

Francois Vandeweyer, Jansse Pharmaceutica, Belgium


During this course all relevant aspects regarding API regulatory starting materials will be discussed. You will learn

  • What has to be considered when a starting materials have to be defined
  • How risk assessment can be applied
  • Which aspects have to be taken into account when applying for a CEP
  • How quality agreements should look like
  • How post approval changes can be handled and
  • How impurities in starting materials can be controlled
Furthermore you will have the opportunity to participate in one of two parallel workshops about
  • How to define suitable starting materials in API synthesis
  • How to defend the choice of the starting material in the submission


According to EU GMP Guide Part II (ICH Q7) an API starting material is a raw material, an intermediate, or an API that is used in the production of an API and is incorporated as a significant structural fragment into the structure of the final API. From this point on, appropriate GMP has to be applied to the API manufacturing steps.

In a marketing authorisation application the applicant has to describe in an ASMF the API manufacturing process. The “API regulatory starting material” has to be clearly designated and the rationale for the point at which the production of the API begins has to be documented. The same applies for a CEP application procedure.

In the last few years assessors have been more and more challenging the proposed regulatory starting materials. E.g. the definition of a starting material has been one of the top deficiencies in CEP applications. This is partly due to the fact that companies tend to describe shorter synthetic routes starting from complex starting materials. Moreover changes of critical quality attributes and the request from the authorities to re-define the starting material can create difficult situations regarding additional efforts and significant delays in the application process.

Target Group

This course is designed for all persons involved in the manufacture of APIs. Furthermore, the seminar will be of interest to personnel from quality assurance, regulatory affairs both from API and pharmaceutical companies and to contract manufacturers.


  • API synthesis: How to define suitable Starting Materials
  • How to defend the choice of the Starting Material in the submission


How to define API Regulatory Starting Materials: What do the guidelines tell us?

  • API Regulatory Starting Materials – overview of guidelines
  • Definition according to the guidelines
  • Global guidelines (ICH Q7 and Q11)
  • US, EU and Japan guidance
  • How to use the term “significant structural fragment”
  • Distinguishing starting meterials from raw materials, reagents and solvent
  • Selection of an appropriate Starting Material
  • Starting Material specification
API Regulatory Starting Materials – Challenges and practical implications for a submission
  • How to use the elements of the guidelines in practice
  • Is a global approach the best way forward?
  • What is the level of detail to be provided?
  • What are the consequences of the choice?
API Regulatory Starting Materials – What is different for Generics?
  • One file fits all?
  • Redefinition of the RSM; practical aspects
  • Practical experiences
Starting Materials and the CEP application procedure
  • Regulatory background
  • Scope of the CEP procedure
  • Provisions of the Guideline PA/PH/CEP (14) 06 “Use of a CEP to describe a starting material in an application for another CEP“
  • Important points to be considered for defining an API starting materials
How to handle post-approval changes
  • Changes to the pre-starting material information
  • Re-definition of the starting material: possible or not
  • Handling changes/variations when multiple stakeholders are involved
From starting materials to APIs: risk assessment and criticality analyses
  • Criticality analysis methods (HAZOP, FMEA etc)
  • Critical quality attributes (CQA) and critical process steps (CPS)
  • Linking CQA and synthesis steps
  • Critical impurities
  • Critical raw materials
  • Process criticality analysis; example
Appropriate controls for Starting Materials manufacturers
  • How to control impurities in a starting material
  • Analytical techniques
  • Optimisation of chromatographic methods
  • Downstream experiments
  • Validation of analytical procedures
  • Qualification of Starting Materials
APIC’s position on Starting Materials
  • Definition of the SM
  • Risk management
  • Qualification of the SM supplier
  • Pre-SM information
  • Handling changes/variations

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