PHARMA SCHOLARS

PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 1 of 12

USER REQUIREMENT
SPECIFICATION

NAME OF THE ITEM: COATING MACHINE

FUNCTIONAL AREA: PRODUCTION

PROTOCOL No.: URS/

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 2 of 12

CONTENT

S.No. Description

1.0 URS Approval

2.0 Objective
3.0 Responsibilities
4.0 Equipment Description & Identification
5.0 User Requirements
6.0 Complementary aspects
7.0 Safety and environmental Protection
8.0 Cleaning maintenance and service
9.0 Rules and Regulation
10.0 Scope of Delivery
11.0 Installation ,Commissioning and Tests
12.0 Qualification/Validation
13.0 Guarantee/Warrantee

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 3 of 12

1.0 URS APPROVAL:

Protocol Prepared By:

Functional area Name Signature Date

Production

URS Reviewed By:

Functional area Name Signature Date

Production

Quality Assurance

Engineering

URS Approved By:

Functional area Name Signature Date

Head Engineering

Head Manufacturing

Head Quality

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 4 of 12

2.0 Objective:

The purpose of this document is to ensure that all the critical aspects of the Equipment,
cGMP & Safety features have been considered in designing the equipment/instrument and is
properly documented.

3.0 Responsibilities:

In accordance with the document, following functions shall be responsible for initiation and
finalization of Equipment user requirement specification. When the work is carried by
contract/ consulting staff, all the work is to be performed under the oversight of
…………….

3.1 Preparation of Document

• User department to prepare the URS

• Ensures that the document is in compliance with current policies and procedures of cGMP
regulations.
• Ensures that the content is sufficient, clearly defined, technically sound and accurate.
• It is a Guidance document to prepare the URS.

3.2 Review of Document

• To be reviewed by Head of the user department and functional department ( Engineering &
Quality assurance)

3.3 Approval of Document

• Approval of document by Head Manufacturing/Head Engineering/Head Quality.

4.0 Equipment Description & Identification:

4.1 Scope:
This document covers all aspects of Users requirements for the Equipment along
with all Attachment, Spare Parts, Change Parts and Accessories to be used in
………….

Scope incorporates understanding and documentation of critical requirements such

as system requirements, cGMP requirements, safety requirements, documentation
requirements and operational requirements.

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 5 of 12
4.2 Purpose:
Purpose of equipment is used in production area for automatic film coating of tablet.

5.0 USER REQUIREMENTS

5.1 System Requirements:

S.No. SYSTEM COMPONENTS SYSTEM REQUIREMENTS

01. Identification Details of Make, Name, Serial. No., Capacity, Model
(In case of
and Year of manufacture should be available
Equipment /Instrument)
02. Model/Type Automatic coating system 60“ with wet scrubber.

03. Capacity Working capacity after coating 75 kgs.

04. Potential Suppliers 1.Neomachine mfg. co. Pvt ltd.

05. Contact parts SS316 with Mirror finish

06. Non contact parts SS304 with matt finish

07. Non metallic contact parts 1. Any material with food grade quality having no
Potential impact on the products.
2. Durable.
3. Must be easily cleanable.
08. Motor & Electrical installations As per machine requirement

09. Machine assemblies Must be covered with SS 304 with matt finish.

10. Machine adjustments Setting with Zero clearance with good accuracy.

11. Packaging & Transport Should be packed and transported in such a way to avoid
any damage during transportation.
12. No. of requirements 02

13. Requirements for any power To be backed up by installed in-house DG set.

failure backup’s

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 6 of 12

5.2 Technical Description

Sr. No. Specification SYSTEM REQUIREMENTS

1. Pan diameter 915 mm YES

2. Pan mouth Diameter 380 mm. YES

3. Hot air temp 30°C-80°C YES

4. Compressed air 27 CFM at 7 kg/cm² pressure YES

5. Coating pan and pan cabinet YES

6. Spray unit YES

7. Hot air with two stage Filtration unit & HEPA filter unit YES

8. Exhaust unit YES

9. Control unit YES

10. Cleaning in place system YES

6.0 COMPLEMENTARY ASPECTS

6.1 Training

Sr. No. Specification SYSTEM REQUIREMENTS

6.1.1 The vendor Shall supply all available information for the YES
adequate exploitation of equipment. For the Compliance of
this purpose at the Job site and/ or at the Vendors Shop.
Vendor’s technical staff shall train customer’s personnel.
The scope of the
Training will be agreed during the contract signature.
6.1.2 The supplier is to include the personnel training activities. YES
The contractor is to specify the foreseen time for:
• Operator/Supervisor training
• Manager Training
• Electrical maintenance training
• Mechanical Maintenance training
6.1.3 The contractor is to specify the personnel background YES
needed for each of the operators maintenance.

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 7 of 12
6.2 Pre Delivery Qualifications (FAT)

Sr. No. Specification SYSTEM REQUIREMENTS

6.2.1 The System or its parts as provided for in the scope of YES
supply shall be pre-installed at the vendors shop prior to
delivery to customer site. Installation will be completed
and documented including mechanical parts as well as
electrical connections of all parts to facilitate taking
over tests at Vendors shop prior to delivery.

6.3 Supplier Technical Documentation Requirements:

Sr. No. COMPONENTS REQUIREMENTS

6.3.1 Drawings Pre Installation Requirements will
• Equipment/Systems electrical drawing. be supplied by Vendor
• Point to point wiring diagram
6.3.2 LIST.
• Equipment and instrument list with
YES
Component description.
• Electrical component parts list with
Description. YES
• Function check list.
YES
• Documentation list. YES

• Spare part list List of spares required for smooth

operation will be
provided by the Vendor at the time
of ordering.

6.4 Technical Manuals

Sr. No. Specification Requirements

6.4.1 Operating handbook YES
6.4.2 Trouble Shooting Guide YES
6.4.3 Equipment Description YES
6.4.4 Equipment specification YES
6.4.5 Calibration Instruction YES
6.4.6 Maintenance Instruction YES
6.4.7 Maintenance Handbook YES

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 8 of 12
7.0 SAFETY AND ENVIRONMENTAL PROTECTION

Sr No. Specification Requirements

7.1 All motors have to be thermally Protected. YES
7.2 All the Installation must be in accordance with the YES
cGMP.
7.3 The cGMP concerning safety must be applied. YES

8.0 CLEANING MAINTENANCE AND SERVICE

Sr. No. Specification

8.1 In accordance with cGMP guidelines the units must be easy to clean, to disinfect, and where
necessary, to sterilize.
8.2 The Supplier should guarantee that, if required, a service team can be on site within one
working day.
8.3 The design should be such as to allow mechanical cleaning of the surface and that the
cleanliness of the surface can be checked easily.
8.4 All machine parts, in particular instrumentation, should be constructed so that they can be
easily removed and calibrated.
8.5 All special tools required for running and maintenance should be best.
8.6 A spare parts delivery guarantee with in time.

9.0 RULES AND REGULATION

These standards, recommendation and requirements are considered the minimum. Specifications
that are more stringent or expansive take the precedence. In case of conflict between published
requirements, final determination is the responsibility of the Owners Representative.

10. SCOPE OF DELIVERY

S. No. Specification Requirements

10.1 Units described in the specific system requirements including all YES
necessary controls and instrumentation.
10.2 The complete mechanical and electrical installation. YES

10.3 The Connections to all the necessary utilities, exhaust, and Yes
waste lines necessary for its operation.
10.4 All piping and cabling of the units itself. YES

10.5 Wiring and cable run: all wiring and cable run is part of the YES
supply. ………… will supply the main power switches to be
located in correspondence to the electrical and control cabinets
delivered by the equipment supplier.

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 9 of 12
10.6 All internal contacts of the supplied equipment for the required YES
utilities.
10.7 Unload on site of the equipment: the supplier is required to YES
define all the necessary handling devices required to the
unloading operation.
The supplier will inform at least 4 weeks in advance the day of
delivery and the list of required handling devices.
10.8 Assembling operation: the required consumable, the internal YES
transportation, the assembling tools and the required personal
are part of the supply.
10.9 A complete set of commissioning spare parts. YES

10.10 All special tools necessary for use and maintenance of the YES
supplied equipment.
10.11 A complete set of two years spare parts should be listed quoted YES
and offered as option.
10.12 All test activities as specified in this document. YES

10.13 Training in the use and maintenance of the equipment. YES

10.14 A complete set of documentation as specified YES

In this document.

11.0 INSTALLATION, COMMISSIONING AND TESTS

11.1 General

Sr.No. Specification Requirements

11.1.1 The Contractor must specify for each piece of equipment the YES
Guaranteed performance and the guaranteed system performance.
These values will be tested during the acceptance tests.
11.1.2 In addition the functionality described in the user requirements and YES
detailed in the system specifications will be tested.

11.2 INSTALLATION , COMMISSION

Sr. No. Specification Requirements

11.2.1 The commissioning tests will be carried out in accordance with a YES
written test plan developed by the supplier with clearly stated test
procedures and acceptance criteria.
11.2.2 The contractor will approve successfully completed tests and will YES
specify items requiring additional work. Representatives from

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 10 of 12
Sr. No. Specification Requirements

…………….. Will attend and participate in the commissioning

tests as required.
11.2.3 The installation and commissioning of the system will be YES
performed at the …………….. Facility by the contractor.
11.2.4 The commissioning can only start once all the foreseen documents YES
have been delivered by the supplier to ……………...
11.2.5 All equipment should be properly installed, adjusted, leveled, YES
tagged, and connected with utilities.
11.2.6 Point to point checks on wiring and pneumatic should be YES
performed.
11.2.7 All instruments should be properly calibrated. YES
11.2.8 A equipment ( instrument) used for qualification must be listed and YES
approved by ……………….
11.2.9 The calibration equipment must have all the necessary documents YES
to demonstrate their maintenance & use.
11.2.10 The last calibration of all this equipment must be less than 6 YES
months old, and evidenced by certificate.
11.2.11 Verification that the interior surfaces of equipment are free of YES
practices and dirt and all points of product contact meet the
specified material requirements.
11.2.12 All the clearances and tolerances specified in the drawing or YES
recommended by component manufacturers are correct.
11.2.13 On site verification that valves and other equipment with moving YES
parts are in their normal position if in a power down condition and
move in the correct direction with the correct speed and precision.
11.2.14 Verification that all the Input and Output points are connected and
labeled according to the documentation and that all the along the
input values have been scaled in accordance with the system
specification and process requirements. That all equipment

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 11 of 12
Sr. No. Specification Requirements

components requiring configuration

11.2.15 The commissioning should demonstrate that the system supplied by YES
the contractor has been properly installed and that the functions are
in accordance with ………………... User Requirements
specifications, Vendors System specifications Manuals and other
Documentation.

11.3 Site Acceptance Test (SAT)

Sr.No. Specification Requirements

11.3.1 This test will be carried out once the commissioning will be YES
completed. The scope will be to verify the performance and the
functionality of the system integrated with the other factory systems
(Including sterility testing of at least 02 days).
11.3.2 The test will be carried out to verify the system response with the YES
expected productivity of the system.
11.3.3 Details on the test realization will be defined during the project YES
Phase. The supplier is asked to specify the proposed duration for
SAT and the standard procedure proposed.
11.3.4 During SAT the required functionality, performances and system YES
reliability are met.
11.3.5 The Functionality described in the User Requirements Specification YES
and in the System Specifications are verified and met.
11..3.6 All the documentation agreed has been delivered. YES

12.0 QUALIFICATION /VALIDATION

S.No. Specification Requirements

12.1 The maintenance Qualification is responsibility of the customer. YES
However, the supplier is responsible for delivering the basic
documents for maintenance qualification.
12.2 This includes all side costs such as : calibration measuring YES
equipment and instruments: manpower (IQ and OQ will take place
completely on ……….)
12.3 Time Schedule for IQ/OQ execution will be developed by YES
…………... With the supplier.
12.4 Suppliers personnel used for IQ/OQ must be well trained and YES

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: COATING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 12 of 12
S.No. Specification Requirements
experienced. This should be documented.
12.5 The onsite test run performed by the supplier might become part of YES
the IQ.
12.6 Main IQ/OQ steps such as calibration must be performed and YES
documented in accordance to a SOP approved by ……………...
12.7 All equipment used for qualification must be listed and approved by YES
……………….. The calibration equipment should be well
documented.
12.8 The last Recalibration of all this equipment should be less than 06 YES
month old. Proofed by Certificate.
12.9 OQ can only start after IQ approved by ……………….. YES
12.10 IQ will be carried out by ……………….. During Installation phase. YES
IQ will include the tests performed by the contractor.
12.11 Part of the OQ will be carried out by ……………….. During YES
commissioning and SAT phase. OQ will include the tests performed
by the contractor.
12.12 After installation of the equipment at customers site. YES
Complementary IQ & OQ tests will be performed by the Customer
and may be supervised by a member of Technical staff.
12.13 Qualification documents DQ, IQ, OQ & PQ
(In case of equipments/Instruments)

13.0 GAURANTEE/WARRANTEE

Sr.No. Specification Requirements

14.1 The System must be guaranteed including all the sub- system and YES
components for a period of 12 months from the date of the system
acceptance for a 03- shift operation.
14.2 The servicing companies involved for the Sub- systems maintenance YES
must be declared and the maintenance group organization described.
Furthermore, the contractor will be directly responsible of the
system assistance and the required operation will be co- ordinate by
him.
14.3 In case of failures, the intervention will be guaranteed by the YES
contractor within a maximum time limit. The contractor is asked to
specify the maximum time limit.
14.4 The supplier is asked to propose as option maintenance and YES
assistance contract after the guarantee expiration.

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