2/14/2016
User R equi r em ent Speci fi cati on ( UR S) of Equi pm ents
User Requirement Specification (URS) of Equipments Preparation of user requirement specification of equipments and instrument used in pharmaceutical manufacturing and quality control. User Requirement Specification Specification URS is a list of all requirements of buyer regarding the equipment to be purch ased. URS is prepared by the equip user department. It is sent to equipment manufacturer to make it as desired criteria. Following points should be included in a pharm aceutical user requirement specification. 1. Introduction: A Introduction: A brief introduction of the equipment should be written. 2. Overview: 2.1 Intended Use: Write the use of the equipment in the manufacturing. 2.2 Capacity: Write the required capacity if the equipment in liter or kgs. 2.3 Space Space Availability: Write W rite the th e available space for installation of the equip ment including height, width and height in mm. 2.4 Accuracy Accuracy of Instrument: Instrument: Write the desired accuracy of the instrument in decimal places if applicable. 2.5 Cleaning Requirements: Instrument should easy to clean. Write, if there is any specific cleaning requirement. 2.6 Equipment Specific Requirements: 2.6.1 Required quality quality of Stainless Steel SS as SS‐308, SS‐316 or SS‐316L if applicable. 2.6.2 Write the specific requirements of the instrument as number of baffles and revolutions per minute RPM in Blender and requirement of fix lid and hand wheel in Paste Kettle. 3. Operational Requirements: 3.1 Functional Requiremen Requi rements: ts: Specify all technical requirements for the equipment. 3.1.1 Operation: Write the operational requirements. 3.1.2 Control System: Specify ON, OFF or other specific equipment control requirements. 3.1.3 Power: Power: Write the requirements requireme nts on on power failure as auto as auto start or manual. manu al. 3.1.4 Safety: Write the the requirements of safety guard and MCB and MCB trips on shor t circuit or overload 3.2 Environment: Temperature and humidity of the area where area where the equipment equipment will be installed. 3.3 Other Requirements: Write the other requirements a s metal of construction construc tion MOC of non contact parts and specific requirements of seals and 4. Compatibility and Support: Sup port: 4.1 Utilities: Available power supply on which instrumen t shall be operated . Requirement of of uninterrupted power supply UPS and other specific u requirement. 4.2 Availability: Continuous operating time of the equipment in hours or working shifts. 4.3 Supporting Documents: Requirements Requirem ents of operating operating manual, circuit diagrams, warranty letter, change part list, spare part list etc. 5. Abbreviations: List Abbreviations: List all abbreviations used in this user requirement specification document. 6. References: Write References: Write the title of reference books or guidelines. 7. Approval: Name & Designation Department Signature Date Prepared By Checked By Approved By Related: Download Sample URS
Ankur Choudhary is is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely‐read pharma widely‐read pharma blog since blog since 2008. Sign‐up for the free email updates for updates for your daily dose of pharmaceutical tips. Email:
[email protected].
http://w ww ww .p .phar ma magui de del in ine.com /2 /2015/01/pr ep epar at ati on on- of of- UR URS- fo for -p -phar ma maceuti ca cal -e -equi pm pm en ents.htm l
1/2
2/14/2016
User Requirement Specification (URS) of Equipments
© 2015 All rights reserved to Ankur Choudhary and data may not be reproduced on other websites. Designed by Pharmaceutical Guidelines. Privacy Policy Disclaimer
http://w ww .phar magui del ine.com /2015/01/pr epar ati on- of- URS- for -phar maceuti cal -equi pm ents.htm l
2/2
