USER REQUIREMENT SPECIFICATION FOR MICROBIOLOGY

The User Requirement Specification for Microbiology (URS) is offered to help the user with the crucial facets of fabrication, facilities for installing necessary equipment, cleaning and proper maintenance, cGMP, Safety, and regulatory requirements. The vendor is then given access to the URS so they may submit a price proposal for the equipment for the microbiology lab. The User Requirement Specification for Microbiology will assist the vendor in fully comprehending the end user demand. The document will aid the vendor in creating the design specification, which, upon client approval, will turn into a contract between the vendor and the customer. The procurement agreement with the vendor will be acknowledged as including the URS as a fundamental component. The vendor shall comply with the disclosures and terms included in this document and the standard.

The following points should be considered in URS:

1. Approval
2. GMP/Regulatory requirements
3. System Overview
4. Technical Specification
5. Safety features/Alarms/Interlocks
6. Life Cycle
   • Development
   • Testing
   • Support
   • Delivery
7. Documents to be attached
8. Review Comments

The entire URS is a work in progress. When the purchase order is finalized, the manufacturer or vendor will be exclusively liable for the performance of the machine stated in the catalog or during negotiation. The specs and information stated in the DQ, which has been jointly signed by the vendor/manufacturer and the head of quality assurance, shall be regarded as the machine’s official specifications. The aforementioned DQ shall be regarded as a part of the purchase order. Prior to URS preparation, the Risk-based approach in the Commissioning and Qualification process is essential to support Critical Quality Attributes and Critical Process Parameters, which are key inputs into URS. URS is a dynamic document that is updated whenever project requirements change or when new risk controls are added.

Reference: https://ispe.org/pharmaceutical-engineering/ispeak/qa-user-requirements-specifications-related-commissioning.

1. URS for 3- Way Dynamic Pass Box
2. URS for Walk-in Cooling Chamber
3. URS for Walk-In Incubators
4. URS for Vertical Autoclave
5. URS for TOC Analyzer
6. URS for QC Isolator
7. URS for Sterility Isolator
8. URS for Deep Freezer
9. URS for Photostability Chamber
10. URS for RLAF
11. URS for Incubation Chamber
12. URS for HPHV Steam Sterilizer
13. URS for Horizontal LAF
14. URS for Hanging LAF
15. User Requirement Specification for Autoclave
16. User Requirement Specification for BOD Incubator 2
17. User Requirement Specification for Colony Counter
18. User Requirement Specification for BOD Incubator 1
19. User Requirement Specification for BOD incubators
20. User Requirement Specification for Double Door Steam Sterilizer
21. User Requirement Specification for Hot Air Ovens
22. User Requirement Specification for Incubator
23. User Requirement Specification for Incubator 2
24. User Requirement Specification for Laminar Air Flow