API Regulatory Starting Materials

Im Auftrag der European Compliance Academy

API Regulatory Starting Materials<p> Im Auftrag der European Compliance Academy

Barcelona, Spain

Seminar Nr. 9246


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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Hiltrud Horn
Horn Pharmaceutical Consulting, Germany
Corina Nachtsheim
Quality Assessor
Matthias Schneider
BASF, Germany
Francois Vandeweyer
Janssen 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 and
How post approval changes can be handled.
Furthermore you will have the opportunity to one of two parallel workshops about
How to identify and control CQAs of starting materials in API synthesis
How to handle Changes to Starting Materials specifications


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.


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.


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
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?

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

From starting materials to APIs: risk assessment and criticality analyses
Criticality analysis methods (HAZOP, FMEA etc)
Critical quality attributes (CQR) and critical process steps (CPS)
Linking CQA and synthesis steps
Critical impurities
Critical raw materials
Process criticality analysis; example

Quality agreements with RSM suppliers
Objectives and contents of Quality Agreements
Negotiations of Quality Agreements – who should be involved?
Notification of changes
Quality agreements concerning starting materials that have also non-pharmaceutical uses

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

APIC’s perspective on Starting Materials
APIC’s position on
Definition of the SM
Risk management
Qualification of the SM supplier
Pre-SM information
Handling changes/variations


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