CHANGE REQUEST – INITIATION AND APPROVAL

Change Request Number: 007

Initiation
Initiator: PRIYAL DOSHI
Title/Department: PRODUCTION SUPERVISOR
Target Implementation Date: 6th MARCH, 2020

Description of Change
NEW LOD GENERAL METHOD CRITERIA FOR SENECOTINE 50mg FC tablets AS PER USP 42-NF 37 DUE TO CHANGE IN RAW
MATRIAL USED TO PREPARE API
Yes (List the Attachments): UPDATED GENERAL METHOD FOR LOD
Attachments: : OLD METHOD WITH REQUIRED CHANGES
No

Impact Assessment
Functional Area Impact Documents/Areas/Departments/Regulations Impacted
Procedure Yes No LOSS ON DRYING GENERAL METHOD

Product Yes No SNC (SENECOTINE 50 mg FC TABLETS)

Equipment Yes No DRYING OVEN WITH VACCUM PUMP, ANALYTICAL BALANCE

Facility Yes No N/A

Validation Yes No METHOD NEED TO BE VALIDATED ACCORDING TO NEW SPECIFICATION CRITERIA

Labelling Yes No NEW LABELING IS REQUIRED TO ACCOMMODATE UPDATED INFORMATION

License Yes No N/A

Training Yes No LAB TECHS AND SCIENTISTS NEED TO BE TRAINED AND AWARE OF NEW METHOD

Other Yes No PRODUCT STABILITY SHOULD STAY INTACT

Required Actions
# Action Owner Target Completion Date
1 NEW LOD METHOD GENERATION XYZ, R&D SUPERVISOR 27TH FEBRUARY, 2020
2 VALIDATION OF NEW METHOD AND API XYZ, RAQA (R&D) 29TH February, 2020
STABILITY CHECK
3 CALIBRATION OF THE DEVICES AND XYZ, ENGINEERING SPECIALIST, PROD. 2ND MARCH, 2020
EQUIPMENT UTILIZED FOR THE VALIDATION PRIYAL DOSHI, PROD. SUPERVISOR
AT PRODUCTION AREA ACOORDING TO NEW
SPECIFICATION
 DRYING OVEN WITH VACCUM PUMP:
NEW TEMP = 60 °C
 TIMER MUST BE RECALIBRATED TO 60
MINUTES
 ANALITICAL BALANCE MUST BE
RECAIBRATED BEFORE ITS USE TO
MAKE SURE ITS IN WORKING
CONDITION
4 VALIDATION OF NEW METHOD AT PRIYAL DOSHI, PROD. SUPERVISOR 2ND MARCH, 2020
PRODUCTION PHASE

PAGE 1 OF 2
Document#: DSCI-FRM-01-001
Version: 1
Effective Date: 1st May, 2018
 CHANGE REQUEST – INITIATION AND APPROVAL

5 TRAINNING:
 Proper handling and storage of new API
 People leader need to be trained so that they
PRIYAL DOSHI, PROD. SUPERVISOR 3RD MARCH, 2020
can inform their team about the updated
XYZ, TEAM LEAD, PROD.
changes and train them about new process

6 NEW SNC MOCK BATCH SHOULD BE PREPARED PRIYAL DOSHI, PROD. SUPERVISOR 4TH MARCH, 2020
ACCORDING TO NEW LOD METHOD AND ALL XYZ, QA, PROD.
THE PRODUCTION CRITERIA SHOULD ATLEAST
PASS OR EXCEL THE SPECIFICATION FOR THE
QUALITY CONTROL CRITERIA BEFORE BATCH
IS VIABLE FOR COMMERCIAL PRODUCTION
7 SIGNATURE OF UNDERSTANDING OF THE LAB PRIYAL DOSHI, PROD. SUPERVISOR 4TH MARCH, 2020
ANALYSITS, LAB TECHS, QA’S AND ANY
RESPONSIBLE EMPLOYEES WHO IS AFFECTED
WITH THIS NEW CHANGE CONTROL MUST BE
TAKEN.
6 ALL DOCUMENTS INCLUDING VALIDATION JITU PATEL, DIRECTOR 5TH MARCH, 2020
REPORTS MUST BE APPROVED BY DIRECTOR

INITIATOR:
Name Title
PRIYAL DOSHI PRODUCCTION SUPERVISOR
Signature Date
ON FILE 27TH February, 2020

Approval
Name Title/Department Approver Date
Signature
JITU PATEL DIRECTOR, PRODUCTION ON FILE 27TH FEBRUARY, 2020

XYZ DIRECTOR, OPERATIONS ON FILE 27TH FEBRUARY, 2020

XYZ DIRECTOR, R&D ON FILE 27TH FEBRUARY, 2020

PAGE 2 OF 2
Document#: DSCI-FRM-01-001
Version: 1
Effective Date: 1st May, 2018
N

NEW METHOD
General Method: Loss on Drying

Method Information:
Method No.: G-LOD-1234-5
Issue: 7
Date Issued: 01/03/2020

Equipment: Drying Oven Equipped with Vacuum Pump

Glass Weighing Dish with cover
Analytical Balance
Desiccator

Procedure:
1. Stabilize oven temperature at 60°C.
2. Heat both the weighing dish and cover at 50°C, at pressure not exceeding 0.7 kPa, for one
hour and cool under desiccator (C).
3. Weigh accurately 1 g of the sample into weighing dish. Record the total weight of the dish with
sample and cover (A).
4. Place into the vacuum oven with the cover off (but in the oven) and dry at 60°C, at pressure not
exceeding 0.7 kPa, for 60 minutes
5. Cover dish, remove from oven and cool in desiccators for 30 minutes and proceed to final
weight immediately.
6. Weigh dish, sample and cover (B).

Calculation:

(A - C) - (B - C)
% LOD   100
(A - C)

A = Total weight of sample before drying

B = Total weight of sample after drying
C = Tare weight

Data Evaluation: Specification: Not More Than 0.5 %

Page 1 of 1
 OLD METHOD WITH
IDENTIFIED CHANGES

General Method: Loss on Drying

Method Information:
Method No.: G-LOD-1234-5
Issue: 6
Date Issued: 07/08/09

Equipment: Drying Oven Equipped with Vacuum Pump

Glass Weighing Dish with cover
Analytical Balance
Desiccator

Procedure:
1. Stabilize oven temperature at 50°C.
2. Heat both the weighing dish and cover at 50°C, at pressure not exceeding 0.7 kPa, for one
hour and cool under desiccator (C).
3. Weigh accurately 2 g of the sample into weighing dish. Record the total weight of the dish with
sample and cover (A).
4. Place into the vacuum oven with the cover off (but in the oven) and dry at 50°C, at pressure not
exceeding 0.7 kPa, for 2 hrs.
5. Cover dish, remove from oven and cool in desiccators for 30 minutes and proceed to final
weight immediately.
6. Weigh dish, sample and cover (B).

Calculation:

(A - C) - (B - C)
% LOD   100
(A - C)

A = Total weight of sample before drying

B = Total weight of sample after drying
C = Tare weight

Data Evaluation: Specification: Not More Than 1.00 %

Page 1 of 1