KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 1 of 20
INSTALLATION QUALIFICATION
FOR
OCTAGONAL BLENDER 2000 LTRS
THIS DOCUMENT HAS BEEN PREPARED BY M/S KOTHARI PHARMA
TECHNOLOGIES PVT LTD
FOR
M/S IBN HERBALS
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 2 of 20
PROTOCOL PRE-APPROVAL
Protocol Prepared by
Preparation of this Qualification Protocol is the responsibility of documentation of
PREPARED & APPROVED BY: KOTHARI PHARMA TECHNOLOGIES PVT LTD
NAME &
APPROVALS DEPARTMENT SIGNATURE DATE
DESIGNATION
PREPARED
QA / QC NIKITA SAWANT
BY
APPROVED
PRODUCTION ASHISH SHUKLA
BY
Protocol Review:
Review of this Qualification Protocol is done by representatives of
REVIEW & APPROVED BY: IBN HERBALS
NAME &
APPROVALS DEPARTMENT SIGNATURE DATE
DESIGNATION
REVIEWED
BY
REVIEWED
BY
APPROVED
BY
AUTHORIZED
BY
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 3 of 20
TABLE OF CONTENT
Sr. No. Description Page No.
1 Objects 4
2 Equipment Description and Scope of Validation 5
3 Abbreviation and Definitions 5
4 Responsibilities 5
5 Data Collection 6
6 Documentation Check 7
7 Drawing Check 8
8 Pre- Start- Up Review Procedure 9
9 Installation Verification 11-15
10 Activity Execution Time Frame 16
11 Deviation and Corrective Action Report 17
12 Installation Qualification Summary Report 18
13 Identification of Personnel Performing The IQ 19
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 4 of 20
1. OBJECTS:
A definition of Installation Qualification is as follows
“The process of confirming that as item of equipment, or other system, as currently
installed, meets its design intentions, specifications and installation requirements.”
The objectives of this Installation Qualification are therefore:
To ensure that the equipment / system conforms to the manufacturer’s description and
Installation requirements.
To ensure that the equipment / system complied with relevant requirements of current
Manufacturing.
To provide a record of key features of the equipment and components as currently
installed.
To ensure that there is sufficient documentation to enable the equipment to be operated
and maintained safely, effectively and consistently.
To ensure that the equipment is in a satisfactory state, to allow the OQ to be performed
safely and with consistently repeatable results.
To ensure that all instruments are calibrated prior to OQ
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 5 of 20
2. EQUIPMENT DESCRIPTION AND SCOPE OF VALIDATION:
1. Octagonal Blender is located in the building.
2. The Octagonal Blender is installation in the GMP area and inlet and exhaust section
are installed in the technical area as shown in the layout drg.
(Ref. Drg No. KPTPL-WJ-OCB2000-2223-02, REV. 01 DTD. 16.06.2022)
3. The scope of this validation study is the installation of Octagonal Blender. Services
are considered from their point of connection to the machine. Inspection and
verification of components is included in this Installation Qualification.
3. ABBREVIATIONS AND DEFINITIONS:
IQ Installation Qualification
OQ Operational Qualification
SOP Standard Operating Procedure
VMP Validation Master Plan
4. RESPONSIBILITIES:
Procedural responsibilities with respect to this validation study are stared is the
VMP specific requirements regarding testing as this equipment.
I. KOTHARI PHARMA TECHNOLOGIES’S RESPONSIBILITIES:
A. Preparation of IQ protocol
B. Purchase Order along with client approval letter.
II. CLIENT’S RESPONSIBILITIES:
A. Approval of the protocol prior to commencement of work
B. Performing and reporting all IQ checks in respect of Octagonal Blender.
C. Approval of final completed report.
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 6 of 20
5. DATA COLLECTION:
5.1 The installation Qualification will comprise the approved copy of this protocol
and of Appended documents. All documents will be completed, as indicated in this
protocol and kept in the appropriate section.
5.2 All people who enter data in this report will be identified in the appropriate
section.
5.3 All approval should be duly signed.
5.4 All data is to be entered in clear handwriting.
5.5 Any corrections to handwritten data will be made by deleting with a single line
and initialing and dating the correction.
5.6 Also, a brief reason for the correction will be given.
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 7 of 20
6. DOCUMENTATION CHECK:
6.1 List below documents which are available at the time of Installation Qualification.
DOCUMENT
WHERE SIGN TO
SR. DOCUMENTATION REFERENCE (NO.
IT IS CONFIRM
NO. CHECK REVISION DATE etc.)
KEPT PROVIDED
OR COMMENTS
IBN/ENGG/06-2022/006
6.1.1 Purchase Order ---
Dtd. 09.06.2022
Client original
6.1.2 --- ---
specification Letter
6.1.3 Operator’s manual YES MANUAL
6.1.4 Drawings YES MANUAL
COMMENTS:
___________________________________________________________________________
___________________________________________________________________________
______________________________________________________________________
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 8 of 20
7. DRAWINGS CHECK:
• Compare the equipment with the general arrangement drawings and mark, as
described, the drawing which are verified. The drawings will be stamped with AS
BUILT” and countersigned.
• Write on the drawing the words ‘INSTALLATION QUALIFICATION DRAWING
CHECK’ sign and date the marked-up prints when the check is complete.
• Attach the marked-up prints to this protocol as an appendix
Sign to
Rev Drawing confirm
Drawing Title Drawing Number
No. Date verified &
appended
G.A Drawing,
KPTPL-WJ-OCB2000-2223-02 01
Plan & Elevation
Electrical
KPTPL-ELE-OCB2000-2223-18 00
Diagram
COMMENTS:
___________________________________________________________________________
___________________________________________________________________________
______________________________________________________________________
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 9 of 20
8. PRE-START - UP REVIEW PROCEDURE:
Before the equipment is operated, the following checks must be completed &
points should be documented.
1. MECHANICAL
Visually inspect the installation so as not be hamper operational qualification work and
future operation.
Sr. No. ITEM INSPECTION STATUS POINTS RAISED
The machine has been positioned
1.
as per the room layout drawing.
2. The machine has been leveled.
3. The machine has been cleaned.
Utilities have been properly
4.
connected.
Visually check the machine for
5.
damage due to transportation. Etc.
COMMENTS:
___________________________________________________________________________
___________________________________________________________________________
______________________________________________________________________
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 10 of 20
2. ELECTRICAL
Visually inspect the electrical installation
Sr. POINTS
ITEM INSPECTED STATUS
No. RAISED
Electrical connections have been
1.
provided and secured
All components in the panel are property
2.
secured
3. All terminals are tightened
4. Check in coming voltage / frequency
5. Earthing station
COMMENTS:
___________________________________________________________________________
___________________________________________________________________________
______________________________________________________________________
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 11 of 20
9. INSTALLATION VERIFICATIONS:
9.1 Identification of Principal components of the system
The components in the system will be given a full inspection according to the check
lists in this section to verify they are present as specified, are correctly documented
and have been correctly installed. Any incorrect installations or deviations from the
specifications or damage must be documented in the “comments” sections on the
following pages, or attached as appendices, with appropriate reference to appendices
given in the appropriate sections below.
The details indicated will be recorded for the equipment as installed.
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 12 of 20
9.1.1 GENERAL COMPONENT LIST:
1. MOTOR
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
MAKE : HINDUSTAN
HP : 7.5
KW : 5.5
SPEED : 1450 RPM
SR. NO. : 20583682
2. GEARBOX
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
MAKE : PREMIUM
TYPE : U500
RATIO : 50:1
SR. NO. : WGP 66419
3. BUTTERFLY VALVE
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
JAY AMBEY
MAKE :
PHARMA
SIZE : Ø 10”
MOC : SS 316
COMMENTS:
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 13 of 20
9.1.2 PANEL COMPOENT DETAILS:
1. VFD
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
MAKE : DELTA
MODEL : VFD055E43A
CAPACITY : 7.5 HP
055E43A7K2307011
SERIAL NO. :
7
2. MCB
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
MAKE : SIEMENS
MODEL : 5SL63327RC
RANGE : 32A/3P
3. MCB
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
MAKE : SIEMENS
MODEL : 5SL61067RC
RANGE : 6A/1P
COMMENTS_______________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 14 of 20
4. PROCESS TIMER
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
MAKE : SELEC
MODEL : XT546
SERIAL NO : 2304T03-804
5. INDICATION LAMP
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
MAKE : TEKNIC
RANGE : 240 V
6. LOAD BREAKAR
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
MAKE : L&T
RANGE : 32A
COMMENTS_______________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 15 of 20
7. TIMER
CHECK BY
DESCRIPTION SPECIFICATION OBSERVATION
DATE
MAKE : SELEC
MODEL : 800SQ-A
QTY : 01 NO
COMMENTS:
___________________________________________________________________________
______________________________________________________________ ___
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 16 of 20
10. ACTIVITY EXECUTION TIME FRAME
This Section shall mention the initiation and completion date of installation qualification activity
Qualification Activity Started On:
Qualification Activity Completed On:
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 17 of 20
11. DEVIATION AND CORRECTIVE ACTION REPORT
Deviation
Corrective Action
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 18 of 20
12. INSTALLATION QUALIFICATION SUMMARY REPORT
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 19 of 20
13. IDENTIFICATION OF PERSONNEL PERFORMING THE IQ:
All personnel entering information in this Installation Qualification protocol must be
identified in the table below.
INSTALLATION QUALIFICATION TEST PROTOCOL POST APPROVAL
PREPARED & APPROVED BY: KOTHARI PHARMA TECHNOLOGIES PVT LTD
NAME &
APPROVALS DEPARTMENT SIGNATURE DATE
DESIGNATION
INSTALLED
BY
APPROVED
BY
REVIEW & APPROVED BY: IBN HERBALS
NAME &
APPROVALS DEPARTMENT SIGNATURE DATE
DESIGNATION
REVIEWED
BY
REVIEWED
BY
APPROVED
BY
AUTHORIZED
BY
KOTHARI PHARMA TECHNOLOGIES PVT. LTD.
INSTALLATION QUALIFICATION
Equipment Name: OCTAGONAL BLENDER 2000 LTRS.
Document No. : KPT/IBN/OCB 2000/2324/82 Manufacturer : PRECIKOT
Customer : IBN HERBALS Year of Mfg : 2023-2024
PO No. : IBN/ENGG/06-2022/006 PO Date : 09.06.2022
Machine Sr. No. : 0485 DTD 20.05.2023 Page No. : Page 20 of 20
CONCLUSION
