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BY PHARMACEUTICAL GUIDANACE ON JULY 14, 2016 INSTALLATION QUALIFICATION(IQ), VALIDATION & QUALIFICATION

TABLE OF CONTENT
Purpose
Scope
Responsibilities
Procedure
Installation Qualification tests
Documents & Drawings Verification
Verification of Technical Specification for In-House & sub-components /
Bought out items FACEBOOK

Utilities Verification
Material of Construction Verification

Critical Instrument calibration verification
Installation Qualification Tests Status
Data Analysis, Summary of IQ & Recommendations
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Amendment Record
Conclusion Be the first of your friends to like this

PURPOSE:
To describe the Installation Qualification procedure to be used during qualification of Single Rotary
Tableting Machine-16 Station, its accessories and to define the specification of the system in order to:
ensure that the equipment meets the specification as Design Qualification.
aid verification of the installation as per equipment general arrangement drawing.
ensure that the system installation meets acceptance criteria
ensure that the equipments will be installed in accordance with current Good manufacturing
Practices.
SCOPE:
This procedure applies to the installation qualification of Single Rotary Tableting Machine-16 Station and
its accessories to be installed.
RESPONSIBILITIES:
It is the responsibility of the Manufacturer to prepare the installation qualification protocol as per
Design Qualification
It is the responsibility of the client to check and approve the installation qualification protocol. FIND US ON GOOGLE PLUS

It is the responsibility of the Manufacturer to perform all the specifications verification checks and
tests with respect to installation qualification and compiling data in co-ordination with client.
PROCEDURE:
The following requirement / practices apply to Single Rotary Tableting Machine-16 Station Installation
Qualification activities:
Verify that systems are installed in accordance with approved engineering drawings and
documents, which shall include the following
General arrangement drawing.
 Installation specification
Equipment manuals
Verify that the equipment and instrumentation are clearly described as per vendor, model, capacity,
materials of construction and any critical criteria.
Verify that major components are tagged or labelled with a unique ID number.
INSTALLATION QUALIFICATION TESTS:
The table below lists the tests to be performed as part of the Installation Qualification phase.

TEST NUMBER CRITICAL FEATURE

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5.1 Documents & Drawings Verification
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5.2 Verification of Technical Specification for
92 seguidores
In-House & sub-components / bought out items

5.3 Utilities Verification

5.4 Material of construction verification

5.5 Critical Instrument calibration verification

Documents & Drawings Verification

Rationale
To verify that the documentation provides complete and correct technical references and permits
servicing of the units.
Test equipment
None Required.
Procedure
Verify that the required documents and drawings listed in the below table are available.
Review the documents and drawings for completeness and exactness with the installed units.
Attach the copies of the drawings or reference the location from where they can be easily retrieved.
Any items in the installation, which are not conforming to the corresponding drawings, must be
commented on in the appropriate space. List the non-conformance and the reasons for them in an
attachment if necessary.
Acceptance Criteria
The documents must be accurate and complete.
The drawing information must correspond to the physical installation.
Documentation Verification Results.

Sr. No Description Document No Verified By Date

1 Installation, Maintenance
and Operation Manual

2 General arrangement
drawing

Verification of Technical Specification for In-House & sub-components / Bought out items
Purpose
To verify that each major component of the Single Rotary Tableting Machine-16 Station are present and
identified.
Test Equipment
None Required
Procedure
Confirm that identification nameplates have been applied to the units and that these indicate
the following (where applicable).
Type
Identification (Tag)
Manufacturer
Model Number
 Confirm that the various components of Single Rotary Tableting Machine-16 Station are present
and tagged as per specifications and drawings, in the proper number and configuration.
Note any deviations or discrepancies and recommend follow up action if required.
Acceptance Criteria
All units and parts specified in design qualification and on latest revision of drawings must be present,
documented and tagged.
Major Components Results

Description Specification Meets Verification Signature Date

Spec. Source
(Yes/No)

1. Equipment Description

Equipment Single Rotary

Name Tableting Machine

Equipment EQ/PR/125
Code

Model No. CPMD3-16

Serial No 251/118

Turret RPM Min = 16

Max = 42

Output (Tablet/ Min = 15360

Hour) Max = 40320

Hopper 21 Liter
capacity

No of Hopper 1 Nos.

Tablet diameter Max = 25.4 mm

Depth of fill 20 mm

Max. Operating 10 Tons

pressure

Overall 900 (L) X 975 (W) X

dimensions (in 2050 (H)
mm, with
guards open)

2. Electrical / Mechanical

2.1. Main Motor

Type 3 Phase Induction

motor, foot mounted

Sr. No. K5608544

Make Bharat Bijlee

Capacity 2.0HP, 935RPM,

415V, 50Hz 5

2.2. VFD

Model Powerflex-40

Sr. No. BD010NOW5420082

Cat. No. 22B-D010N104

Make Allen Bradley

2.3. Hydraulic Gauge

Sr. No. 06-03/212

Range 0-10 Tons

 Least Count 0.25

Make Clit

2.4. Oil Pump

Model No. AM

Sr.No. 1120

Make CPMPL

2.5. Safety Guard Interlock Switch

Qty. 04 Nos.

Sr. Nos. 5/18413, 6/00311,

5/10511, 6/00300

Make KATLAX

2.6. Upper Punch Sensor

Sr. No. 7746-03/06

Power rating 10-35 VDC

Make Osna Electronics

2.7. V-Belt

Size C-85

Qty. 01 Nos.

3. Control Panel

3.1. Main Drive

Controls Stop, Start Push buttons

Qty. 02 Nos.

3.2. Electro Magnetic Clutch

Controller Engage, Disengage push

buttons.

Qty. 02 Nos.

3.3. Safety Guard Interlock / Bypass Switch

Qty. 01 No.

3.4. Digital Counter

Type 7 digit counter

Model MC-203

Sr. No. 06041010

Options RPM/ Count/ Pr. Rate

3.5. Ampere Meter

Make Rishabh

Location Control Panel

Range 0-5

3.6. Emergency Switch

Qty. 01 No.

Utilities Verification
Rationale
To verify that all necessary utilities are correctly installed.
Procedure
 Confirm that utilities connections are configured as per specification and in compliance with
local codes.
Record the results in the table below. Note any deviations or discrepancies.
Acceptance Criteria
All services and connections must be installed and documented.
Utilities Specification Results

Description Specified Observation Initial / Date

mm/dd/yy

Electrical connection To be provided

Material of Construction Verification

Rationale
To verify that all assembly of Single Rotary Tableting Machine-16 Station has been manufactured as per
the specification provided by the customer.
Test equipment
Moly testing unit (To identify 304 or 316 materials)
Procedure
Put a drop of Molybdenum solution on the material to be tested.
Take battery & keep anode at one end of the material and cathode at Moly drop.
If the solution turns pink and stays for around one minute, then it is SS316 & if the solution
turns pink and immediately vanishes, then it is SS304
Acceptance Criteria
All material of construction for the Single Rotary Tableting Machine-16 Station shall meet the
MOC provided in Design Qualification.
Material other than SS316 and SS304 are verified based on their material testing certificates
provided by the Manufacturer.
Material of Construction verification Results

Description Specification Meets Verification Signature Date

Spec. Source
(Yes/No)

Turret SGI

Turret Diepot Ring SS 316

Discharge Spout SS316

Hopper SS316

Hopper Lid SS316

Critical Instrument Calibration Verification

Rationale
To verity that all critical instruments for the Single Rotary Tableting Machine-16 Station has been
calibrated before starting the Operational Qualification.
Procedure
 Verify that all critical instruments are calibrated using an approved procedure, against a traceable
standard.
Note any deviations or discrepancies and recommend follow up actions if required.
For all critical instruments, attach copies of calibration certificates to this document.
Acceptance Criteria
All critical instrumentation for the Single Rotary Tableting Machine-16 Station shall be in a state of
calibration.
Instrumentation List Results

Description Make Least Count Set point Current

Operating Calibration
Range
Yes/No Sign / Date

Hydraulic Gauge Clit 0.3 0-10 tons

Installation Qualification Tests Status

The table below lists the tests performed and related results.

Test Number Critical Feature Pass / Fail Deviation Found

Pass Fail Yes No

5.1 Documents & Drawings Verification

5.2 Verification of Technical Specification for

In-House & Sub-contract / bought out
items.

5.3 Utilities Verification

5.4 Material of Construction Verification

5.5 Critical Instrument calibration verification

Data Analysis, Summary of IQ & Recommendations

AMENDMENT RECORD

Sr. No. Item Name Remarks Signature & Date

Note: Any changes made in the system must be recorded in this sheet.
CONCLUSION

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