Work status on 21-02-2025

 Revised the qualification SOPs

 Certified to operate program activity is under progress.

22-02-2025

Description unit Drafting/ Done by status

review
SCA for HPLC Fto9 DRAFT [Link] Rohith Since IQ execution is pending
flow meter from user ,SCA is in progress and
QCE-160 the work done until that is sent
for review to Nalam Satish Kumar
SCA for HPLC Fto9 DRAFT [Link] Rohith Since IQ execution is pending
flow meter from user ,SCA is in progress and
QCE-159 the work done until that is sent
for review to Nalam Satish Kumar
OQ for TOC Fto9 review [Link] Rohith completed
Analyser
URS review FT09 review [Link] Rohith Comments shared to the user
for H2O2
Generator
(Production)

24-02-2025

Revised the WORK INSTRUCTION FOR VALIDATION DELIVERABLES document: WI-GLOB-IT-0058

Revised the hardware installation qualification checklist for GxP workstations format-FORM-GLOB-
IT-0015

Communicated with Production lead Vinay Kumar Kalepu for the list of non-compliance systems and
enlisting of the respective systems is in progress due to unavailability of data with him and he said he
will share as soon as he will have them.

Interacted with QC team to get some idea about the QC related Equipment.

25-02-2025
  Gone through the IQ protocol for Laboratory computerized systems

 Gone through the OQ protocol for Laboratory computerized systems

 Coordinated with FTO9 Production Lead Vinay Kumar Kalapu to obtain the non-

compliance systems list.

 The non-compliant system list has been shared in excel format via mail by Vinay

Kumar.

 Compared it with the list sent by Nalam Satish Kumar and observations found were

shared with him.

26-02-2025

Description unit Drafting/ Done by status

review
SLIA for FTO9 review [Link] Rohith Observations shared to user
SKAN wireless
Glove integrity
tester network
extenders

Enlisting of FTO9 draft [Link] Rohith

non-
compliance
systems
( Production)

28-02-2025
Description unit Drafting/ Done by status
review
Functional verification - FTO9 - [Link] Rohith Gone through the WI-GLOB-QA-
control panel testing 0707
Functional FTO9 review [Link] Rohith Studied how the document is
verification- control tailored according to the
testing for rheometer respective equipment
for forFT9-
FT9INS1009569-CPT-
0001.01

1-03-2025

Description unit Drafting/ Done by status

review
Operation of Electronic FTO9 - [Link] Rohith Perused the SOP-GLOB-IT-0067
validation (eVal) system to use eval application
GLB-S4HANA-PM-VI - Discussion [Link] Rohith COMPLETED
4000004539 with the user
regarding
verification
template
WI-GLOB-IT-
0239
 03-03-2025

Description Unit Drafting/ Done by Status

review
SCA for tablet compression machine
sent for review to
A/PR-E177 FT07 draft [Link] Rohith
N. Satish Kumar
General Verification - Major
Component Verification for
Rheometer (Instrument ID: FTO9 review [Link] Rohith Completed
1009569) FT9-FT9INS1009569-
MCV-0001.01
Functional Verification – Control
Panel Testing for LBPC Liquid
Borne Particle Counter FTO9 review [Link] Rohith Completed
([Link]: 2405013)
FT9-FT9INS2405013-CPT-0001.01

04-03-2025
Drafting/
Description Unit Done by Status
review
FT9-FT9INS1009569-CPT-0001.01 FTO9 Review [Link] Rohith completed

FT9-FT9INS1006014-CPT-0001.01 FTO9 Review [Link] Rohith completed

Installation and operational

qualification protocol for all
compounding and filtration vessels FTO9 Review [Link] Rohith Comments shared to the user
VALPR-FT09-001045
Compounding vessel Eq Id:2628457

05-03-2025

Drafting/
Description Unit Done by Status
review
URS Traceability matrix for
compounding vessel ([Link]:
FT09 REVIEW [Link] Rohith completed
2628443) VAL-FTO9-002286
Production
Installation and operational
qualification protocol for all
compounding and filtration vessels FT09 Review [Link] Rohith completed
VALPR-FT09-001045 Compounding
vessel Eq Id:2628416
IOQ protocol for Lyophilizer [Link]
2604936 FTO9 Review [Link] Rohith Comments shared to the user
VALPR-FTO9-001079
 6-03-2025

Drafting/
Description Unit Done by Status
review
SCA for Compounding vessel -50L
FTO9 Draft [Link] Rohith Completed
2628443
SCA for tablet compression machine
A/PR-E177 Updated with corrections
FTO7 Draft [Link] Rohith
made by Satish Kumar

7-03-2025

Drafting/
Description Unit Done by Status
review
IOQ protocol for Lyophilizer [Link]
2604936 FTO9 Review [Link] Rohith CSV sign completed
VALPR-FTO9-001079
DQ protocol 21 CFR part 11
compliance system for high pressure
FTO9 Review [Link] Rohith Comments shared to user
homogenizer SKID AND
REPORTS eq id : 2405246
Functional specification 21 CFR part
11 compliance system for high
FTO9 Review [Link] Rohith Comments shared to user
pressure homogenizer SKID AND
REPORTS eq id : 2405246

10-03-2025

Drafting/
Description Department Unit Done by Status
review
Operational qualification test script of
water system centralized SCADA for Comments shared to
Engineering FTO9 review [Link] Rohith
FT09 facility user
FT9-SCADAWS-OQTS-0001.02
DQ protocol 21 CFR part 11 compliance
User updated the
system for high pressure homogenizer Production FTO9 review [Link] Rohith
comments
SKID AND REPORTS eq id : 2405246
Functional specification 21 CFR part 11
compliance system for high pressure User updated the
Production FT09 review [Link] Rohith
homogenizer SKID AND REPORTS eq comments
id : 2405246
 11-03-2025

Drafting/
Description Department Unit Done by Status
review
Functional specification 21 CFR part 11
CSV approval
compliance system for high pressure Production FTO9 Review [Link] Rohith
completed
homogenizer eq id : 2405246
DQ protocol 21 CFR part 11 compliance
CSV approval
system for high pressure homogenizer Production FTO9 review [Link] Rohith
completed
SKID AND REPORTS Eq Id : 2405246
Installation qualification 21 CFR part 11
compliance system for high pressure Pre- Approval sign
Homogenizer SKID AND REPORTS Production FTO9 review [Link] Rohith completed from CSV
side
eq id : 2405246

12-03-2025

Drafting/
Description Department Unit Done by Status
review
CSV approval
FT9-SCADAWS-OQTS-0001.02 Engineering FTO9 review [Link] Rohith
completed
Discussion with the
Multi cartridge system for BET
QC-micro FTO9 - user regarding the
analysis IQ,OQ,PQ protocols

13-03-2025

Drafting/
Description Department Unit Done by Status
review
General Verification – Major
component verification for QC-micro FT09 draft [Link] Rohith completed
Endoscan nextgen MCS 4139039
Functional Verification - Control
Panel Testing for Endoscan Nexgen- QC-micro FT09 draft [Link] Rohith completed
MCS For Bet Analysis(4139039)
Hardware Installation
Qualification Checklist for GxP
system- FT9-2629043
Comments shared to
-IQCGW-0001.01 Production FTO9 Review [Link] Rohith
the user
Compounding Vessel 50l
[Link] : 2629043
 17-03-2025

Drafting/
Description Department Unit Done by Status
review
FT9-2628416-IQCGW-0001.01-E-01 for [Link]
Production FTO9 Review Comments shared to user
Compounding vessel-300L - 2628416 Rohith
Discussion on observations
User requirement specification of Jumo [Link]
Engineering FTO9 - found during review of
Paper less recorder. VAL-FT09-002299 Rohith
document

18-03-2025

Drafting/
Description Department Unit Done by Status
review
User requirement specification of Jumo [Link]
Engineering FTO9 review completed
Paper less recorder. VAL-FT09-002299 Rohith
Hardware Installation Qualification
Checklist for GxP Discussion on observations
[Link]
system- FT9-2629043-IQCGW-0001.01 Production FTO9 -
Rohith
found during review of
Compounding Vessel 50l document
[Link] : 2629043
General Verification – Major component
[Link]
verification for Endoscan nextgen QC-micro FT09 draft In progress
Rohith
MCS 4139039

19-03-2025

Drafting/
Description Department Unit Done by Status
review
Design Qualification for compounding [Link]
production FTO9 Review Comments shared to user
vessel-200ltr DQ-1901224-CV200 Rohith
FS for compounding vessel 200l [Link]
production FTO9 review Comments shared to user
FS-CV200L Rohith

System level impact assessment for

compounding vessel 200L [Link]
production FTO9 review Completed
Rohith
SLIA-CV200L
[Link]
SVR for BMS (EQ ID: 2207703) Engineering FTO9 draft
Rohith
50% completed
 20-03-2025

Drafting/
Description Department Unit Done by Status
review
[Link] Uploaded the vendor
BMS (EQ ID: 2207703) Engineering FTO9 draft
Rohith documents in eval
IOQ for jumo Paper less recorder [Link]
Production FTO9 review Comments shared to user
SVU-PLR-IOQ-001 Rohith

Design qualification for paperless

recorder (Jumo) [Link]
Production FTO9 review Comments shared to user
Rohith
SVU-PLR-DQ-001

21-03-2025

Drafting/
Description Department Unit Done by Status
review
[Link]
FS of compounding vessel CV50 Production FTO9 review
Rohith
Comments shared to user

[Link]
FS of compounding vessel CV200 Production FTO9 review
Rohith
Comments shared to user

[Link]
FS of Filtration Vessel FV200 Production FTO9 review
Rohith
Comments shared to user

[Link]
QTR for BMS (EQ ID: 2207703) Engineering FTO9 DRAFT
Rohith
In progress

24-03-2025
Drafting/
Description Department Unit Done by Status
review
Final assessment of ER-ES compliance for
BMS [Link] Comments shared to the
Engineering FT09 Review
Rohith user
FT9-FT9BMS-FERES-0001.01
[Link]
IQ for Endoscan -Nexgen QC-micro FTO9 draft Sent for review
Rohith
Hardware Installation Qualification Checklist
for GxP Workstations [Link]
Production FTO9 review CSV approval completed
Rohith
FT9-2628457-IQCGW-0001.01-E-0
 25-03-2025
Drafting/
Description Department Unit Done by Status
review
[Link]
SVR for BMS (EQ ID: 2207703) Engineering FTO9 draft
Rohith
Sent for review

Risk assessment to mitigate the risk

[Link] Comments shared to the
associated with the upgradation of PLC & Engineering FTO9 review
Rohith user
IPC of isolator 2406729
Completed
Analytical Instrument or equipment [Link]
- - - SOP-GLOB-QC-
Qualification Rohith
0095-5.0

26-03-2025
Drafting/
Description Department Unit Done by Status
review
Risk assessment to mitigate the risk
[Link]
associated with the upgradation of PLC & Engineering FTO9 review
Rohith
completed
IPC of isolator 2406729
Discussion
on the target
[Link]
Endoscan Nexgen BET analysis QC-micro FT09 dates for
Rohith
-
CSV
deliverables
[Link]
QTR for BMS (EQ ID: 2207703) Engineering FTO9 DRAFT
Rohith
Updated

27-03-2025
Drafting/
Description Department Unit Done by Status
review
[Link]
Steriline isolator of vail line and cRABS Engineering FTO9 review
Rohith
completed

General verification major component [Link]

QC-micro FTO9 draft completed
Verification for Endoscan –Nexgen Rohith
 28-03-2025
Drafting/
Description Department Unit Done by Status
review
System validation Report for water
[Link]
system centralized SCADA for FT09 engineering FTO9 DRAFT Sent for review
Rohith
facility.
Qualification Test Report for water
system centralized SCADA for FT09 [Link]
engineering FTO9 DRAFT Sent for review
Rohith
facility.
RTM for water system centralized
SCADA for FT09 facility. [Link] Comments shared to the
engineering FTO9 Review
Rohith user

31-03-2025
Drafting/
Description Department Unit Done by Status
review
OPERATIONAL QUALIFICATION
PROTOCOL 21 CFR PART 11
[Link] Comments shared to the
COMPLIANCE FOR HIGH PRESSURE Production FTO9 review
Rohith user
HOMOGENIZER-SKID & REPORTS
RIAC/INK/DR-OQ/00
RTM for water system centralized
SCADA for FT09 facility. [Link]
engineering FTO9 Review Updated
Rohith

ER-ES for water system centralized

SCADA for FT09 facility. [Link]
engineering FTO9 Review Updated
Rohith
 1-04-2025
Drafting/
Description Department Unit Done by Status
review

[Link]
IOQ for compounding vessel 200L Production FTO9 Review Comments shared to user
Rohith

IQ pre approval for Compounding 10 Isolator

(4138997) [Link] Comments shared to the
Production FTO9 Review
Rohith user

OQ pre approval for Compounding 10 Isolator

[Link] Comments shared to the
(4138997) Production FTO9 Review
Rohith user

Alarm and Function Testing Plan - IPC [Link]

Production FT09 Review completed
Function for compounding 10 isolator Rohith

2-04-2025
Drafting/
Description Department Unit Done by Status
review
Super-Heated Water Sterilizer Installation
[Link] Comments shared to the
Qualification Protocol (IQ)( Pharma Grade Production FT09 Review
Rohith user
Superheated Water Sterilizer)

Super-Heated Water Sterilizer Operational [Link] Comments shared to the

Production FT09 Review
Qualification Protocol (OQ) Rohith user

Alarm Function Test (AFT) for PLC system [Link]

Production FT09 Review Completed
for ISOKLENZTM AS MFG 2400. Rohith
 3-04-2025
Drafting/
Description Department Unit Done by Status
review

Hardware Installation Qualification Checklist

QC- [Link] Comments shared to the
for GxP Workstations execution FT9- FT09 Review
microbiology Rohith user
4139039-IQCGW-0001.01-E-01 for Endoscan
Nexgen MCS - 4139039
Checklist for leveraging of instrument
QC- [Link]
qualification documents –Nexgen MCS FTO9 Draft In progress
microbiology Rohith
Endoscan

Super-Heated Water Sterilizer Installation

[Link]
Qualification Protocol (IQ)( Pharma Grade Production FT09 Review completed
Rohith
Superheated Water Sterilizer)

Super-Heated Water Sterilizer Operational [Link]

Production FT09 Review completed
Qualification Protocol (OQ) Rohith

4-04-2025
Drafting/
Description Department Unit Done by Status
review
IOQ for compounding vessel 200L
[Link] Comments shared to the
production FT09 review
Rohith user
Eq id: 2628457

[Link]
GXP assessment for JUMO paperless recorder production FTO9 draft In progress
Rohith

7-04-2025
Drafting/
Description Department Unit Done by Status
review
Checklist for leveraging of instrument
QC- [Link]
qualification documents –Nexgen MCS FTO9 Draft completed
microbiology Rohith
Endoscan

[Link]
GXP assessment for JUMO paperless recorder production FTO9 draft Sent for review
Rohith

[Link]
Excel sheet preparation for ATAR production FTO9 In progress
Rohith
 8-04-2025
Drafting/
Description Department Unit Done by Status
review
Reviewer Qualification
[Link]
- - Training completed
Rohith
SOP-GLOB-QA-0040-5.0
Change management system
[Link]
- - Training completed
Rohith
SOP-GLOB-QA-0061-14.0

[Link]
Excel sheet preparation for ATAR Production FTO9 draft In progress
Rohith

[Link] Comments shared to the

IOQ for Compounding vessel 50L (2629043) Production FTO9 review
Rohith user

9-04-2025
Drafting/
Description Department Unit Done by Status
review

[Link]
Excel sheet preparation for ATAR Production FTO9 draft In progress
Rohith

PRIVILEGE attachment verification against

[Link]
privilege matrix for Compounding vessel 50L Production FT09 review In progress
Rohith
(Eq.Id2629043)
IQ for HPH – skid and reports (post approval)
Eq. Id:2405246 [Link]
Production FT09 review completed
Rohith
 10-04-2025
Drafting/
Description Department Unit Done by Status
review

Excel sheet preparation for ATAR [Link]

Production FTO9 draft In progress
(PRODUCTION) Rohith

IQ for HPH – skid and reports (post approval) [Link]

Production FT09 review CSV sign completed
Eq. Id:2405246 Rohith

Computer System Validation I - An [Link]

- - Training Completed training
Introduction Rohith

Design qualification (DQ) of case packer [Link]

Production FT09 review completed
system (JEK/CP100/DRL/DQ-01) Rohith

[Link]
FT9-FT9-2404615-IQCGW-0001.01-E-01 Production FTO9 REVIEW Completed
Rohith

[Link]
FT9-VDT-IQCGW-0001.01-E-01 Production FTO9 REVIEW Comments shared to user
Rohith

11-04-2025
Drafting/
Description Department Unit Done by Status
review

Excel sheet preparation for ATAR [Link]

Production FTO9 draft In progress
(PRODUCTION) Rohith

[Link]
FT9-FT9-2404615-IQCGW-0001.01-E-01 Production FTO9 REVIEW CSV approval Completed
Rohith

[Link]
FT9-VDT-IQCGW-0001.01-E-01 Production FTO9 REVIEW Csv approval completed
Rohith

[Link]
IOQ of paperless recorder(make:Yokogawa) production FTO9 REVIEW completed
Rohith

PQ PROTOCOL for Endosafe Nexgen [Link]

microbiology Fto9 draft completed
Endoscan-v Rohith
 14-04-2025
Drafting/
Description Department Unit Done by Status
review

[Link]
Excel sheet preparation for ATAR Production FTO9 draft In progress
Rohith

[Link]
Excel sheet preparation for ATAR microbiology FTO9 draft In progress
Rohith

Privileges attachment for B&S Vial line [Link]

Production FT09 review done
isolator Rohith

[Link]
OQ for B&S Vial line isolator Production FT09 review completed
Rohith

PRIVILEGE attachment verification against

[Link]
privilege matrix for Compounding vessel 50L Production FT09 review completed
Rohith
(Eq.Id2629043)

15-04-2025
Drafting/
Description Department Unit Done by Status
review

[Link]
Excel sheet preparation for ATAR Production FTO9 draft In progress
Rohith

Software compliance assessment for X-Ray

[Link]
Diffractometer(QC-E218) with Diffrac. Suite QC FT07 draft completed
Rohith
Software with MC

[Link]
Excel sheet preparation for ATAR microbiology FTO9 draft In progress
Rohith

Discussion regarding
[Link]
SLIA for Huber chiller 4138553 production FT09 - categorization with user is
Rohith
completed

Execution
[Link]
PFS vial line IOQ( 2404616 ) production FT09 (along with In progress
Rohith
IT)

16-04-2025
 Drafting/
Description Department Unit Done by Status
review
Execution
[Link]
PFS vial line IOQ( 2404616 ) Production FT09 (along with In progress
Rohith
IT)

[Link]
SLIA for Huber chiller 4138553 Production FT09 review CSV sign completed
Rohith

17-04-2025
Drafting/
Description Department Unit Done by Status
review
Operational Qualification Protocol 21 CFR
[Link] Comments shared to the
Part 11 Compliance For High Pressure production FT09 review
Rohith user
Homogenizer-Skid & Reports

Operation Qualification – Test Evidence [Link]

production FT09 review Comments shared to user
Compounding vessel-300L ( 2628416) Rohith

[Link] Completed
SLIA for JUMO production FT09 review
Rohith

Execution
[Link]
PFS vial line IOQ( 2404616 ) Production FT09 (along with completed
Rohith
IT)

18-04-2025
Drafting/
Description Department Unit Done by Status
review

[Link]
DQ for Hubber chiller Production FT09 review COMPLETED
Rohith

SAT IOQ protocol for 50L compounding

vessel ([Link]:012Z24-50L-CV1 [Link] Observations shared to the
Production FT09 review
Rohith user
Doc no:SAT-IOQ-012Z24-50L-CV1)

[Link]
PFS vial line IOQ( 2404616 ) Production FT09 review CSV sign completed
Rohith

21-04-2025
Description Department Unit Drafting/ Done by Status
 review
OPERATIONAL QUALIFICATION
PROTOCOL 21 CFR Part 11 Compliance [Link]
production FT09 review completed
System for High Pressure Homogenizer Rohith
EQP ID: 2405246
DQ fro compounding vessel 200L
[Link]
production FT09 review completed
Rohith
DQ-1901224-CV200

[Link]
Jumo recorder DQ review production FTO9 review completed
Rohith

[Link]
ATAR for production production FTO9 draft In progress
Rohith

22-04-2025
Drafting/
Description Department Unit Done by Status
review
Jumo recorder IOQ review
[Link] Comments shared to the
production FTO9 review
Rohith user
SVU-PLR-IOQ-001

[Link]
ATAR for production production FTO9 draft In progress
Rohith

[Link]
ATAR for microbiology QC FT09 draft In progress
Rohith

23-04-2025
 Drafting/
Description Department Unit Done by Status
review
Compounding vessel -300L privilege
attachment [Link] Comments shared to the
production FT09 review
Rohith user
eq id: 2628416

[Link]
ATAR for production production FTO9 draft In progress
Rohith

[Link]
ATAR for microbiology QC FT09 draft In progress
Rohith

[Link]
SDS _ HMI upgradation 10L CV 2603243 production FT09 review Comments shared to user
Rohith

[Link]
SDS _ HMI upgradation 10L CV 2603244 production FT09 review Comments shared to user
Rohith

[Link]
SDS _ HMI upgradation 10L CV 2604223 production FT09 review Comments shared to user
Rohith

24-04-2025
 Drafting/
Description Department Unit Done by Status
review

[Link]
SDS _ HMI upgradation 20L CV 2604224 production FT09 review Comments shared to user
Rohith

[Link]
SDS _ HMI upgradation 20L CV 2603970 production FT09 review Comments shared to user
Rohith

[Link]
SDS _ HMI upgradation 20L CV 2603971 production FT09 review Comments shared to user
Rohith

[Link]
SDS _ HMI upgradation 300L CV 2603193 production FT09 review Comments shared to user
Rohith

Addendum SAT installation & operational [Link]

production FT09 review completed
qualification protocol(2603243) Rohith

Addendum SAT installation & operational [Link]

production FT09 review completed
qualification protocol(2603244) Rohith

Addendum SAT installation & operational [Link]

production FT09 review completed
qualification protocol(2604223) Rohith

[Link]
HDS for compounding vessel 2603243 10L production FT09 review completed
Rohith

25-04-2025
 Drafting/
Description Department Unit Done by Status
review

[Link]
SDS _ HMI upgradation 300L CV 2603194 production FT09 review Comments shared to user
Rohith

[Link]
SDS _ HMI upgradation 300L CV 2603195 production FT09 review Comments shared to user
Rohith

[Link]
SDS _ HMI upgradation 300L CV 2603196 production FT09 review Comments shared to user
Rohith

[Link]
HDS for compounding vessel 2603244 10L production FT09 review completed
Rohith

Addendum SAT installation & operational [Link]

production FT09 review completed
qualification protocol 20L CV (2604224) Rohith

28-04-2025
Drafting/
Description Department Unit Done by Status
review

[Link]
FT9-FT9INS1005963-IQCGW-0003.01-E-01 production FT09 review Comments shared to user
Rohith

[Link]
FT9-3203199-IQCGS-0001.01 production FT09 review Comments shared to user
Rohith

[Link]
ATAR for production production FTO9 draft In progress
Rohith

29-04-2025
 Drafting/
Description Department Unit Done by Status
review

[Link]
HDS for compounding vessel 2604223 20L production FT09 review completed
Rohith

[Link]
HDS for compounding vessel 2604224 20L production FT09 review completed
Rohith

[Link]
HDS for compounding vessel 2603970 20L production FT09 review completed
Rohith

GxP assessment for tofflon filling line [Link]

production FT09 draft In progress
2605354A-D Rohith

[Link]
ATAR for production production FTO9 draft In progress
Rohith

30-04-2025
Drafting/
Description Department Unit Done by Status
review

GxP assessment for Tofflon filling line [Link]

production FT09 draft COMPLETED
2605354A-D Rohith

[Link]
ATAR for production production FTO9 draft In progress
Rohith

[Link]
ATAR for PACKING production FTO9 draft In progress
Rohith

5-5-2025
 Drafting/
Description Department Unit Done by Status
review

Quality [Link] Comments shared to the

FT9-FT9INS1007478-IQCGW-0001.01 FT09 review
control Rohith user

[Link]
IOQ of 300CV 2628416 production FT09 review Comments shared to user
Rohith

[Link]
ATAR for packing packing FT09 draft inprogress
Rohith

6-5-2025
Drafting/
Description Department Unit Done by Status
review

Quality [Link]
FT9-FT9INS1007478-CPT-0001.01-E-01 FT09 review Comments shared to user
Control Rohith

[Link]
ATAR for packing packing FT09 draft 90% completed
Rohith

[Link]
ATAR for Engineering packing FT09 draft In progress
Rohith

7-5-2025
Drafting/
Description Department Unit Done by Status
review
Design qualification document for LAUDA
[Link]
IN1030T production FT09 REVIEW Comments shared to user
Rohith
[Link]: 4300008080/1030T

Attachment verification for IQ OF HIGH

[Link]
PRESSURE HOMOGENIZER production FT09 draft In progress
Rohith
UPGRADATION

[Link]
ATAR for Engineering packing FT09 draft In progress
Rohith

8-5-2025
 Drafting/
Description Department Unit Done by Status
review

FT9-FT9-WGIT-4200943 & 4269680- [Link]

production FT09 review completed
IQCGW-0001.01-E-01 Rohith

[Link]
ATAR for packing packing FT09 draft completed
Rohith

[Link]
ATAR for engineering packing FT09 draft 80% completed
Rohith

[Link]
ATAR for QC QC FT09 draft IN PROGRESS
Rohith

9-5-2025
Drafting/
Description Department Unit Done by Status
review

[Link]
ATAR for engineering packing FT09 draft completed
Rohith

[Link] Comments shared to the

FT9-1015158-URSI-0001.01 QC FT09 review
Rohith user

[Link]
ATAR for QC QC FT09 draft IN PROGRESS
Rohith

URS Traceability matrix for SKAN GIT

Tester software (Equipment ID No. Manufacturing
[Link]
4200943,4269680). science and FT09 review completed
Rohith
technology

12-5-2025
Description Department Unit Drafting/ Done by Status
 review

Installation Qualification ISOKLENZTM AS [Link]

production FT09 review completed
MFG 2400 COMPOUNDING ISOLATOR Rohith

[Link] Comment shared to the

FDS of NVPC counter monitoring system production FT09 review
Rohith user

Operational Qualification ISOKLENZTM AS [Link] Comment shared to the

production FT09 review
MFG 2400 COMPOUNDING ISOLATOR Rohith user

[Link]
OQ part of wireless GIT (4200943, 4269680) production FT09 review completed
Rohith

Installation Acceptance Test Protocol

Online Non-Viable and Viable Particle
Counter Monitoring System
[Link] Comments shared to the
For The production FT09 review
Rohith user
Klenzaid Isolator

13-5-2025
Drafting/
Description Department Unit Done by Status
review

Training on personnel entry and exit [Link]

warehouse FT07 training completed
procedure into warehouse 5.0 Rohith

[Link]
SCA for Wireless GIT (4200943, 4269680) production FT09 Draft completed
Rohith

[Link] Comments shared to the

FT9-1015158-URSI-0001.01 QC FT09 review
Rohith user

21 CFR Part 11 Compliance Readiness

Assessment for Software Acquisition / [Link]
production FT09 review completed
Upgrades for compounding isolator(Klenzaids Rohith
Contaminations Control Private Limited)

14-5-2025
Drafting/
Description Department Unit Done by Status
review
 [Link]
FT9-FT9INS1007478-CPT-0001.01-E-01 QC FT09 review completed
Rohith

Review is completed by
Routed for [Link]
SCA for wireless GIT (4200943, 4269680) production FT09 CFTs, Approval is pending
CFT review Rohith
by QA

[Link]
IAT for NVPC-CMS for Klenzaid isolator production FT09 review Comments shared to user
Rohith

[Link]
ATAR for production production FT09 DRAFT 80% COMPLETED
Rohith

15-4-2025
Drafting/
Description Department Unit Done by Status
review

[Link]
SCA for wireless GIT (4200943, 4269680) production FT09 draft QA Approval is completed
Rohith

VERIFICATION OF BUFFER
[Link] Execution of user
SYSTEMS:WALK- IN COLD CHAMBER Ware-House FT09 -
Rohith management screenshots
2635337-WH-E027

[Link]
ATAR for MSAT MSAT FT09 DRAFT 90% COMPLETED
Rohith

16-5-2025
Drafting/
Description Department Unit Done by Status
review
Online Non-Viable and Viable Particle
Counter Monitoring System For The
[Link]
Klenzaid Isolator production FT09 review
Rohith
Comments given to user

[Link]
ATAR for production production FT09 DRAFT 90% COMPLETED
Rohith

IOQ CV [Link] 2628416

[Link] COMMENTS shared to
VALPR-FT09-001045 production FT09 review
Rohith user

Equipment Qualification Protocol for Huber [Link] COMMENTS shared to

production FT09 review
UC 210Tw H Rohith user

19-5-2025
Drafting/
Description Department Unit Done by Status
review

QC(MICRIBI [Link]
ATAR for MICROBIOLOGY FT09 DRAFT in progress
OLOGY) Rohith

Operational Acceptance Test Protocol

Online Non-Viable and Viable Particle [Link] Comments shared to the
production FT09 REVIEW
Counter Monitoring System Rohith vendor
For the Klenzaid Isolator

URS for online Non-viable and viable air

[Link]
borne particle counter for compounding- 10 production FT09 REVIEW completed
Rohith
isolatorVAL-FT09-002346

[Link]
FT9-FT9BMS-SVR-0001.01 engineering FT09 draft completed
Rohith

Installation Acceptance Test Protocol Online

Non-Viable and Viable Particle Counter
Monitoring System for The Klenzaid Isolator [Link]
production FT09 review CSV review completed
Rohith

20-5-2025
Description Department Unit Drafting/ Done by Status
 review

QC(MICRO [Link]
ATAR for MICROBIOLOGY FT09 DRAFT in progress
BIOLOGY) Rohith

[Link]
ATAR for QC QC FT09 DRAFT In progress
Rohith

Installation Qualification ISOKLENZTM AS [Link]

production FT09 REVIEW Csv sign completed
MFG 2400 COMPOUNDING ISOLATOR Rohith

Functional specifications ISOKLENZTM AS [Link]

production FT09 REVIEW In-progress
MFG 2400 COMPOUNDING ISOLATOR Rohith

21-5-2025
Drafting/
Description Department Unit Done by Status
review
(Privilege attachment) Operational
[Link]
qualification protocol for High Pressure Production FT09 Review Comments shared to user
Rohith
Homogenizer EQ. ID: 2405246

Privilege matrix correction -Compounding [Link]

Production FT09 Review Comments shared to user
isolator 4138997 Rohith

21CFR part 11 compliance readiness [Link]

packing FT09 Review Csv sign completed
assessment for XIA3 Xray Image Analyzer Rohith

[Link]
VEQ for XIA3 Xray Image Analyzer packing FT09 Review Csv sign completed
Rohith

22-5-2025
Description Department Unit Drafting/ Done by Status
 review

[Link]
SLIA for X-Ray inspection machine packing FT09 Review completed
Rohith

Design Qualification Of X-Ray Inspection [Link]

packing FT09 Review completed
System Rohith

Functional specifications ISOKLENZTM AS [Link]

production FT09 REVIEW completed
MFG 2400 COMPOUNDING ISOLATOR Rohith

23-5-2025
Drafting/
Description Department Unit Done by Status
review

[Link]
FT9-FT9BMS-QTR-0001.01 packing FT09 draft routed for QA approval
Rohith

FT9-1014240-UTM-0001.01 [Link]
QC FT09 Review Comments shared to User
(Atomic absorption spectrometer) Rohith

[Link]
FT9-1015158-URSI-0001.01 QC FT09 Review QA approval completed
Rohith

26-5-2025
Description Department Unit Drafting/ Done by Status
 review
Installation and operational qualification for
[Link]
compounding isolator VALPR-FT09-00119 production FT09 review completed
Rohith
(Eq. ID No. 4138997)
Installation and operational qualification
protocol for all compounding and filtration [Link]
production FT09 Review CSV sign completed
vessels VALPR-FT09-001045 Compounding Rohith
vessel Eq Id:2628416
SCA for Software compliance assessment for
QC(microbi [Link]
Endoscan Nexgen-MCS For Bet FT09 DRAFT 40% completed
ology) Rohith
Analysis(4139039)

Entry And Exit Procedure For Employee

[Link]
(Male And Female) And Visitors For Non - - training completed
Rohith
Critical Area (10.0)

27-5-2025
Description Department Unit Drafting/ Done by Status
 review

[Link]
FT9-FT9BMS-QTR-0001.01 engineering FT09 draft QA approval completed
Rohith

[Link]
FT9-FT9INS1007478-UTM-0001.01 QC FT09 review Comments given to user
Rohith

FT9-1014240-UTM-0001.01 [Link]
QC FT09 review Comments given to user
Rohith

[Link]
FT9-1015523-VBI-0001.01 QC FT09 review Comments given to user
Rohith

Software compliance assessment for [Link]

QC FT09 Draft 70% completed
AAS-1014240 Rohith

28-5-2025
Drafting/
Description Department Unit Done by Status
review

Installation and operation qualification for [Link] Comments shared to the

production FT09 Review
paperless recorder (Jumo) Rohith user

[Link]
OQ attachment for HPH upgradation 2405246 production FT09 review Comments given to user
Rohith

[Link]
SVR for jeckson system patch upgradation packing FT09 draft 60% completed
Rohith

Software compliance assessment for [Link]

QC FT09 Draft Sent for review
AAS-1014240 Rohith

29-5-2025
Description Department Unit Drafting/ Done by Status
 review

[Link]
DQ for X-ray inspection system packing FT09 review CSV sign completed
Rohith

[Link]
FDS for X-ray inspection system packing FT09F review CSV sign completed
Rohith

Hardware design specifications for X-ray [Link]

packing FT09 review CSV sign completed
inspection system Rohith

SLIA for Online nvpc & vpc monitoring [Link]

production FT09 review CSV sign completed
system Rohith

(Post-Execution)IOQ for compounding vessel- [Link] Comments shared to the

production FT09 review
50L 2629043 Rohith user

IOQ for density meter Eq ID:1015158 [Link]

QC FT09 review CSV sign completed
(PRE APPROVAL) Rohith

30-5-2025
Drafting/
Description Department Unit Done by Status
review

Interim SVR for BMS ( version EBI [Link]

engineering FT09 draft Routed for review
R610) Rohith

Updated according to new

[Link]
SCA for AAS(101420) QC FT09 draft template and Sent for
Rohith
review

[Link]
SVR for jeckson system patch upgradation packing FT09 draft 70% completed
Rohith

2-6-2025
 Drafting/
Description Department Unit Done by Status
review
[Link]
URS Traceability Matrix for Atomic Rohith
QC FT09 review Comments shared to user
Absorption Spectrometer (ID: 1014240)

[Link]
URS Traceability Matrix for Atomic Rohith Comments shared to the
QC FT09 review
Absorption Spectrometer (ID: 1007478) user

Software compliance assessment of Micro [Link]

production FT07 draft 30% completed
Fluidizer-2 (A/PR-E184) Rohith