“Leading Towards Pharmaceuticals Self Reliance”

Association of Pharmaceutical Producers of Nepal (APPON)

Technical Workshop on
Dosage Development &
Technology Transfer at Site
(Design, Team, Project Plan, Process Mapping, Regulatory & Traceability)

Speaker:
Experts - Focelite

Venue: Hotel Siraichuli, Bharatpur, Chitwan

Date: 3-5 May 2023

Organized by: Technical Co-operation: Supported by:

APPON
Quality Circle
 Program Outline & Objectives
 Scope of Work – Designing Specification for Project
 Product Literature Search Report
 Product Development Strategy
 Site Master File requirement checklist
 Audit of Technology Document
 Investigation Map of Process formulation & Analytical
 Project Planning Gant Chart
 Team Communication

Expected Outcomes
 Know the theory and practical aspects of Drug Bank
 Get knowledge for setting the parameters for clinical equivalence – Clinical
Trail.com.
 Be familiar with the concept of Dosage Development
 Have clarity over theTechnology Transfer pre - preparation
 Get Knowledge of proper documentation as per regulatory requirement
 To have clarity on all the aspects of timeline, team, monitor, review check
point & project traceability which will be helpful in the commercial
production product with proactive strategy to control recall.
 Be familiar with stability testing program.

Rationale for selecting Ibuprofen Dosage

 Common molecule with multiple strength, dosage & packing format
 Temperature sensitive impacting stability so will help to understand control
strategy better.

Training Program Details

Training Program : Technical Workshop on Dosage
Development & Technology Transfer Site
Total Number of days : 3 days
Program Start Date : 3 May 2023
Program End Date : 5 May 2023
Venue : HOTEL SIRAICHULI, Bharatpur, Chitwan

Training By : CI4Growth – Reimaging Businesses

Joint Initiative by : Focelite & ALS
Accreditations : USFDA/ISO/IEC:17025/CDSCO
Registration fee
For at least three participants from one organization: NRs. 8500 per pax
Below three participants: NRs 10,000 per pax
 P R O G R A M S C H E D U L E

3 May 2023
Time Topic for Session Trainer

08:30 onwards Registration

09:00 – 09:30 Opening Session
09:30-11:30 Dosage Development & Scope of work - Project Specification Fundamentals
and theory of the following Parameters will be discussed in detail.
 API Selection & Sources Criteria
 Patent Review
 Formulation RLD Characterization
11:30-12:00 Q & A session Vijay Kumar Ranka
Komal Minhas
12:00-12:45 Networking Luncheon Break
12:45-14:15 To design project various parameter for successful transformation will
be shared and discussed for the following parameters covering definition,
Reference guidance, Regulatory Market Criteria and calculation for
 Preformulating & Protype Studies
 MFR development & Optimization
 Prototype Formulation Stability and Packing
 Packaging
 Project Inclusion, Assumptions & constraint
14:15-14:30 Coffee Break
14:30- 15.30 Q & A session
15.30– 17:00 To form team and assign case studies to prepare Scope of work – for case study workshop
[Participants shall conduct assigned case studies work at their Home/Hotel by group formed during the training]

4 May 2023
Time Topic for Session Trainer

09:00–10:00 Review of Case studies Query from the team – Scope of work
10:00-11:30 Product Literature Search Report
 Drug Substance Physiochemical Properties
 RLD Regulatory Aspect
 Clinical Study reference
 Monograph /Non compendial
 Formulation Type Vijay Kumar Ranka
11:30-12:00 Q & A session Komal Minhas
12:00-12:45 Networking Luncheon Break
12:45-14:15 Product development strategy preparation consisting of
 Development Approach  Process flow  Quality Target Product Profile
 Risk assessment – drug substance overview
 Risk assessment – Formulation Variables overview
 Process Variables
 Analytical Development Strategies
14:15-14:30 Coffee Break
14:30- 16:00 Project execution consisting
• Internal Audit of Document & Traceability
• Internal Audit of Process & Traceability
• Process Mapping Diagram
• Technology Transfer Checklist
16:00 – 17:00 To form team and assign case studies to prepare Literature Search and
Development Strategy – for case study workshop
[Participants shall conduct assigned case studies work at their Home/Hotel by group formed during the training]
 5 May 2023
Time Topic for Session Trainer

9.00 -10:00 Review Case Study: Product Literature Search Report &
Product Development strategy clarification

10:00AM-11:00PM Project Planning Tools – Gant Chart details into effective

ways to do efficient plan in order to minimize the outlier in
the production as well market compliant thereby increasing
yield and connect team for monitoring & Review Srinivas,
 Introduction Vijay Kumar Ranka,
 How it works Komal Minhas

11:00- 12:00 Inputs required to fill information

• Category – Stake holder dept excel merger into track summary
• Timelines Interchain connectivity & Impact in delivery
• Investigation Root cause – source & CAPA
• Project Case Studies

12:00 -12:45 Networking Luncheon Break

12:45 – 14:15 Clarification & Feedback from Team on Training

14:15-14:30 Coffee Break

14:30-15:00 Q&A

15:00 – 16:00  Wrap up and conclusion

 Certificates Distribution
 Closing Ceremony

APPON
Quality Circle

4th floor, Bagmati Chamber 401, Teku, Kathmandu, Nepal

G.P.O. Box No. 23528, Tel. /Fax: 4100024, 4231871, Email: appon123@gmail.com
Website: www.appon.org.np