Preparation of User Requirement Specification (URS) SOP

SOP for User Requirement Specification

• SOP covers below points:
  • What is URS in Pharma
  • URS preparation procedure
  • URS format

1.0 OBJECTIVE :

• To describe the procedure for recording the desired specifications of machines (equipment, instrument, utility or component) before purchase in standard format.

2.0 SCOPE :

• This SOP is applicable to major machine (equipment, instrument, utility or component) of Production, Engineering, Quality control department before finalization of an order. While placing an order purchase department has to ensure that URS is available at Plant.

3.0 RESPONSIBILITY :

• Head of User Department (Production, Quality Control, Engineering)
• Head of Engineering Department
• Head of Purchase Department

4.0 ACCOUNTABILITY:

• Quality Assurance Head

5.0 PROCEDURE :

5.1 URS is a predetermined specification before ordering any major machine (equipment, instrument, utility or component). URS is designed by a technical expert from respective department & forwarded to vendor before finalizing an order.

5.2 The custody of original document as a hard copy is with Quality Assurance Department. The photo copy is issued to user department as CONTROLLED COPY and to purchase department as UNCONTROLLED COPY Additional copy can also be issued as per their requirement.

5.3 The original document is part of Qualification document.

5.4 Prepare URS in standard format (annexed to this SOP) by user department before placing purchase order with the consultation of engineering department, if required.

5.5 URS of production equipment is prepared by Head of Production, Checked by Head of Engineering and Approved by Head/Designee of Quality Assurance Department.

5.6 URS of QC Instrument is prepared by Executive/Designee of Quality Control, Checked by Head of Engineering for only simple instrument, i.e., Stability chamber, reverse laminar air flow etc, but for sophisticated instrument, i.e., HPLC, GC, UV etc. by QC Head and Approved by Quality Assurance Head/Designee.

5.7 URS of utility or component is prepared by Head of Engineering, Checked by Head of Production department and Approved by Quality Assurance department.

5.8 Issue soft copy of URS format to all Department Heads for drafting URS and making hard copy.

5.9 Waiver can be raised by concerned user in case of repeat purchase, standard model (like HPLC) etc.

5.10 Include following content at the time of preparation of URS;

• Introduction: A brief introduction of the  machine (equipment, instrument, utility or component) should be written.
• Overview:
  • Intended use: Include the use of machine in manufacturing/testing.
  • Specific requirement : Include specific requirement of the machine,  i.e., RPM of machine, requirement of handle (type of handle), hand wheel, Model number, if available etc.
  • Capacity: Include the required capacity of machine/equipment, utility or component with minimum/maximum range.
  • Accuracy: Include the desired accuracy of machine.
  • Space Availability/Required: Include the available/required space for installation of the machine, i.e., Length, Height, Width & Weight in metric system.
  • Cleaning Requirement: Include, if there is any specific cleaning required.
• Engineering Requirement
  • Electric Power: Include the requirements on power failure as Auto start or manual.
  • Safety feature: Include the requirements of safety guard, limit/micro switches and MCB trips on short circuits.
  • Earthing : Include the requirement for safety.
• Operational Requirement
  • Functional requirement: Include functional requirement of machine.
  • Operational requirement: Include operational requirement of machine.
  • Control Requirement: Include control requirement of machine, i.e., ON/OFF, Emergency control.
  • Environment: Temperature and humidity of area where machine will be installed.
  • Automation/PLC: Include the requirements of Automation/PLC for Auto start, make of PLC.
• Compatibility/ Support:
  • Utilities: Available power supply on which machine shall be operated or any other utilities.
  • Occupancy: Continuous operating time of the machine in hours or working shifts.
  • Supporting document: List out supporting document of machine, i.e., operating manual,  P & I Diagram, DQ, IQ, OQ & PQ.
  • Recommended Source/Vendors: Name of recommended source/vendors of major machine e.g.;
    • HPLC: :M/s. Agilent Technologies, M/s. Shimadzu.

5.11 Abbreviation: List all abbreviation used in the URS

5.12 References: Document used as reference for preparation of URS.

5.13 Approval

• Signatory of URS should be common with qualification team member.

 6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
URS	User Requirement Specification
MCB	Miniature Circuit Breaker
RPM	Revolution/Round per minute
PLC	Programmable logic controller
DQ	Design Qualification
IQ	Installation Qualification
OQ	Operation Qualification
PQ	Performance Qualification
HPLC	High Performance Liquid Chromatography
GC	Gas Chromatography
UV	Ultra Violet
GEP	Good Engineering Practices
ISPE	International Society for Pharmaceutical Engineering

7.0 ANNEXURES:

Annex .No.	Title
01	Format for User Requirement Specification

8.0 SOP REFERENCES

• GEP-Good Engineering Practices

END OF THE SOP

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ANNEXURES :

Annex. No. 01 Format for User Requirement Specification

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