Marieke van Dalen
MARA Consultancy
Referent:innen
Dr. Matthias Schneider
BASF
Francois Vandeweyer
VDWcGMP Consulting
Dr. Cornelia Nopitsch-Mai
formerly Quality Assessor
Dr. Gerd Jilge
Formerly Boehringer Ingelheim
Zielsetzung
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
Hintergrund
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.
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.
Zielgruppe
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.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
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 materials from raw materials, reagents and solvent
- Selection of an appropriate Starting Material
- Starting Material specification
API Regulatory Starting Materials – Do all Authorities Expect the Same?
- Differences between the expectations of health authorities
- Consequences in case of changes
- Practical experiences
Changes in Regulatory Starting Material Supply/Suppliers
- What kind of changes could occur?
- How to classify these changes?
- What information to submit?
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 material
From Starting Materials to APIs: Risk Assessments 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
Workshops
- API synthesis: How to define suitable Starting Materials
- How to defend the choice of the Starting Material in the submission
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
How to Audit Starting Material Manufacturers
- Impact of ICH Q7 Q&A and ICH Q11 on auditing Starting Material manufacturers
- Health Authority and Regulatory expectations
- Risk-based approach on “How to “ audit Starting Materials
- Development and use of the APIC guideline on auditing Starting Materials
- Practical examples and case studies
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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