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