10. What can I bring to Yiling?
• Management Skill and Team Build Up
• Compliance, R&D GMP and Regulatory Affair
• Scientific/Technical/Problem-solving Skills
• Project Management
11. Who am I and Why am I here?
• Background: Separation Science
• Experienced in Team-building
• 10 FDA approved ANDA
• 40 presentations and papers
• New Challenge
15. R&D Analytical
13 function groups
Validation Group
GC Group
API& Excip Qualif. Group
Method Development &
Formulation Support Group
Leader
Analytical Quality
Stability Group
Specification
Heavy Metal
Example: Analytical R&D
Dietary Suppl. Method
Lab Operation(CA&COS) Dissolution
Development
Technical Writing
Preformulation
Support
17. Formulation Group Support
1. Preformulation
2. Formulation development
3. Compatibility study
4. QbD study
5. Pilot/bio batch support
6. Cleaning validation
7. Process validation
8. Specification
9. Formulation trouble-shooting
19. 研发管理流程和优化
1. Tasks in detail
2. Timeline
3. Task owner
4. Define your own subtasks
5. Weekly update the progress
20. Example of ANDA R&D
task 1 Project preparation and research
Task 2 Formulation and Process Development and Analytical support
task 3 Specification
task 4 Method feasibility study and development
task 5 Method validation/verification/transfer protocol
task 6 Method validation/verification/transfer Lab work
task 7 Method validation/verification/transfer report
task 8 Method SOP
task 9 Dissolution profile and F2 value
task 10 Reference Standard Control
task 11 RLD,API and Excipient Full release test and their COAs
task 12 Formulation and process development
task 13 Stability study report and commitment
task 14 pre-BE study
task 15 BE study
task 16 Other studies
task 17 ANDA final
task 18 ANDA review and approval under FDA
21. Example: subtasks
task 1 Project preparation and research
1 Patent search
2 RLD purchase
3 API and impurity reference standards
4 USP monograph for API
5 USP monograph for product
6 API sources
7 API DMF and COA
8 Excipient sources
9 Excipient1 COA
10 Excipient2 COA
11 Excipient3 COA
12 Excipient4 COA
13 Excipient5 COA
14 FDA IIG table
15 FDA Drug label
16 FDA dissolution and USP dissolution condition
17 FDA BE study guidance
18 special equipment for production
19 special equipment for analytical
20 container and closures
21 RLD chemical test and reverse engineering
22 RLD physical test
23 puncher design and order
24 Packaging Components
24. Pilot Batch Readiness list
1 trial report(prestability and compatability results),
2 final formulation
3 specification for raw material, in-process and product
4 pilot batch record
5 punch, container and closure, packaging material
6 COA for all the excipients
7 raw materials ready for at least 4 submission batches,
8
commercial equipment list and their cleaning and process validation
protocols
9 submission batch record and packaging record
10 stability protocol ready
11 analytical methods transferred
12 raw materials and container tested and released
13 test for in-process and finished product
14 Cleaning validation
15 RLD COA
36. Is this mission possible?
Superior technical skills
Decision maker
Project breakdown and management
Team up and Assembly line
Work smartly and time management
Persistence and work hard
Compliance and GMP documentation
Problem solver
37. How to make the mission possible?
Task 1
Task 2
Task 3
Task 4
Task 5
Task 6
Task 7
