During this course all relevant aspects regarding API regulatory starting materials will be discussed. You will learn
What has to be considered when 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 join two workshops about
How to define suitable starting materials in API syntheses
How to defend the choice of the starting material in the submission
Background
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. 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.
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.
Testimonials
Seminar Programme as PDF