red otc development seminar

Question 1

what does red otc means? (for marketing partners)

Answer 1

a creative, capable, independent and flexible partner in consumer health care markets in Europe and beyond

Question 2

what does red otc means? (for contract Manufactring organizations)

Answer 2

a partner for multiplying their businesses

Question 3

what does rd otc do?

Answer 3

porject managment
interational licensing
create new otc medicines

Question 4

what are some comparison criterias for choosen the right project managment tools?

Answer 4

Price, publicity,
satisfaction ( easy to use and user friendly interface
Data storage

Question 5

what are points which you have to considern during the development of the control of development stages?

Answer 5

the regulatory hurdles need to be considered

Question 6

Control of Development stages-1?

For Medicinal Products with Chemically defined APIs Development Projects

Answer 6

Pre-Formulation Studies
 Flavor and composition investigation
 API characterization
o Polymorphism
o Stability
Compatibility
 Characterization of reference product (reverse engineering)
o Supply of reference product

Question 7

Control of Development stages-1? (2)

For Medicinal Products with Chemically defined APIs Development Projects

Answer 7

• API order / stock
 Lead time
 Certification (CEP, DMF)
 Storage and stability
• Analytical Method Development-API
 Monographed , own methods?
 Method validation

Question 8

Control of Development Stages-2

Answer 8

• Laboratory Scale Production (non-GMP)
 Feasibility batches
 Initial dissolution trials
 Fixing the final composition

• Pilot Scale Production (non-GMP)
 Scale up trial
 Confirmation of specifications (non-validated methods)
 Start of Pre-Stabilty
o Different packaging material

• Analytical Method Development-FDF
 Method validation

Question 9

Control of Development Stages-3?

Answer 9

• Pilot Scale batch production (Registration batches-GMP)
 ICH stability
 After 6 months of stability data => Dossier registration / MA application*
 Stability on bulk
 Samples for BE studies

• Full-Scale (Commerical Scale) batch production (Validation batches-GMP)
 Process validation data
 Can be used for commercial purposes