Project Title: REDUCING VARIATION IN COATING PROCESS OF LACOSAMIDE TABLETS

Business Case: Quantity of defective tablets is around 10% to the expected yield
Problem Existing coating process generates around 178 kg of defective tablets each batch.
Statement:

COST OF POOR QUALITY:

The value of proportionate amount of (defective) tablets, would equate to 0.39 million
US$ per batch, provided if the tablets is able to meet the description parameter.
Project Goal: To reduce the process variations in coating and to improve the overall yield.
Project team Member_1: Mr.Vishal Gaikwad, Associate Director, OpEx (Project Director)
Member_2: Mr.Arun Prasad, Manager, OpEx
Member_3: Mr.Kapil Sedwal , Manager, Production
Member_4: Ms.Pooja , Manager ,Process development
Member_5: Mr.Prakash , Asst Manager , Quality Assurance

Sponsor: FTO3 Operations, Bachupally, Hyderabad.

Costing code: 910  Business Vertical; Global Generics, ABC labs
Project 02nd Aug 2021 Kick off date
Milestones:
01st Sep 2021 Review_1 with Leadership team
04th Oct 2021 Review_2 with Leadership team
01st Nov 2021 Review_3 with Leadership team
st
31 Dec 2021 Project End date

Project Additional revenue of 0.2 million US$ /batch.

impact/benefit:
Annual increase in revenue of 6 million US$/year
Anticipated quantity of Process waste would be around 2.2% (to the expected yield) (ie)
Overall reduction by 7.8%/batch.
Project Team Role Name Responsibilities
roles and Master Black Belt Mr. VISHAL GAIKWAD Mentor
responsibilities: Black Belt_Lead Mr. ARUN PRASAD Overall accountability
Green Belt_member Mr. KAPIL SEDWAL Process simulation;
Performance Qualification for Coating
Operation
Green Belt_member Ms. POOJA Design of Experiment studies; Coating
process finalization; Equipment PLC
configuration: Production order creation.
Yellow Belt_member Mr.PRAKASH Planning the set of activities in
accordance as per QMS;
Arranging requisite documentation.

Page 1 of 2
Project Charter_Lacosamide tabs. V1.0
Other Miscellaneous pre-requisites:
i. The identified personnel are required to be deployed from the project activities from 29 Aug 2021.
ii. Creation of Dedicated document repository in directory: K > OpEx > Lacosamide Tablets.
iii. User login with Manager privilege’s for Honeywell PLC -Glatt [EID012]
iv. Revision of BMR for including optimization conditions.
v. Roles updation in PASX module.
Name & Designation Sign with date
Prepared By Arun Prasad,
Manager Op Ex-FTO3
Reviewed by Vishal Gaikwad
Associate Director OpEx
V.Venkatnarayanan
Authorized by
Plant Head-FTO3
S. Padmanabhan
Vice President-Operations
Ramnath
Vice President-FR&D
Ganadish Kamat
Vice President-Quality

Page 2 of 2
Project Charter_Lacosamide tabs. V1.0