URS User Requirement Specification in Pharma 2023

URS is the most important document of every pharmaceutical industry which include all information about the particular system or equipment/Machine. URS is the 1^st pillar of the VMP Validation Master Plan. URS has all information like Capacity, technology requirements, technical requirements, operational requirements, all types of specifications, etc. In the pharmaceutical formulation plant, the prime user department of the machine or system will be responsible for the preparation of user requirement specifications of that equipment/instrument/Machine/System with help of all SMEs

Introduction: 

The URS has been initiated by the user department of every organization for the procurement of equipment. The end user proposed the URS of equipment, production department has initiated the document which shall be reviewed by Engineering, EHS, Quality control, Quality Assurance / Validation & all stakeholders. The URS shall help the supplier to understand the end-user requirements in detail and also help the supplier or OEM for developing design specifications. This also works as a contractual agreement between the supplier and the organization.

Scope: The scope of this URS document is limited to the particular equipment. Case packer.

Utilization: Brief about the operation or use of the equipment. (Equipment used for mixing, Drying, packing etc.)

Operation Requirements and details of the machine:

• Brief about the speed & operation requirements.
• Brief about the different access levels with different password protection
• Size & capacity brief.
• Brief about the event of system malfunctioning or loss of electricity all the related article/recipe remains unchanged.
• The machine has a lock & key provision alarm system.
• The system shall have a facility for data backup through a pen drive and/or CD.
• When a breakdown/malfunction occurs, the supplier shall provide immediate service support.
• Equipment having labeled and identified control wiring with all tags.
• The machine shall be easy to operate with minimum set-up time.
• The machine has a screen/HMI shall be a color touch screen.
• The machine shall be capable to work continuously 24×7.
• Machines have been designed in such a way that they shall be easily synchronized with upstream & downstream machines. Following will be the sequence of the complete process:

   Downstream equipment      ⇒     Equipment to be Precured      ⇒        Upstream Equipment

• Equipment Noise level shall be within 80db at full speed of machine measured at 1 meter of distance.
• The machine shall be provided with a polycarbonate safety guard with an AC-3 category interlock limit switch on each guard.
• Necessary guarding arrangement for a nip and pinch point (conveyor belt, roller, gear).
• Provision of appropriate warning labels/safety signage at the appropriate place at the relevant part of the machine.
• There shall be the provision of a safety device with a mechanical stop in the event of overload.
• The machine shall be provided with HMI (Human Machine Interface) in the operating panel with information like low air, guard open, conveyor jam, machine overload, Speed of the machine, etc.
• Supplier shall give warranty for 3 yrs. against any manufacturing defect of mechanical parts. OEM will extend the service support as and when required in the warranty period of 3 yrs. and also replace the defective/broken parts with manufacturing defects during the warranty period.
• Supplier shall provide a list of recommended and consumable spare parts in hard copy.
• The machine has an emergency switch.

Data and security:

• The machine has full automation mode as per organizational requirement
• Automatic activation of the various functions of the machine shall be in each phase of the process.
• Hierarchical password protection to enter or edit the data up to 3 levels.
• User ID / Login ID shall be provided to up to 10 individual users.

Operation time: The machine runs 24 X 7 & as per production plans

Training:  OEM has to conduct On-site training on the following topics:

• Equipment operation
• Maintenance
• Cleaning process
• Troubleshooting

Compatibility and support:

• OEM shall specify the entire utility requirement with respect to quantity &
• OEM shall provide Factory Acceptance Test.
• OEM shall install & validate the machine at full speed.
• OEM shall advise & helps us in the implementation of a full-automated line.
• The machine shall be able to pack products in compliance with cGMP norms.
• The OEM shall provide the list of critical spares & their lead time.
• OEM shall provide the terms & conditions for service maintenance/after-sales support.

Material of construction:

• All contact parts are made of SS 304.
• External finish –Matt

Documentation Requirements mentioned in URS:

• DQ, IQ, OQ, FAT document.
• Calibration certificates of gauges/instruments used in the machine.
• Bill of material of bought-out hardware items.
• Alarm list (Diagnostic and system generated.)
• Test certificates of electrical motor showing performance.
• Electrical drawings.
• GA drawings/Layout drawings of the machine.
• Pneumatic drawing.
• Maintenance, operational, and spare part list manuals
• The hard copy of Manuals.
• Change over Instructions,
• Maintenance instructions,
• PLC Ladder logic on HMI screen.
• Automated control system Input/output list required for PLC Screen Shot.
• Operational manual of automated control system with HMI screenshot of each operation.
• Software back UP (Encrypted form).
• Credentials of the personnel deputed by the manufacturer for performing the installation and supporting activities.

FAQ Regarding URS:

If you want a draft copy or any other details about the Machine URS please  write us at: admin@flairpharma.com

You may also click for guidelines here.