TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS
Table of Contents
|6||Inspection and Testing|
|7||Commissioning and Documentation|
|S. No.||Parameters||Required Specifications|
Material of Construction
|Specification as per Requirement
Smooth Finish/matt finish/mirror finish
Non flameproof / flameproof
Data & Security
User interface with supervisors and operators for the control platform
Interface with other equipments and system
Component Reference details
Power failure / recovery
(These parameters are filled if applicable.)
Preferably the sound alarms / beep shall be provided along with light indication
In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, air or other major utility and will require operator intervention to
The emergency stop mechanism(s) shall be provided.
|To provide utilities at ONE POINT is user’s responsibility. Supplier to give details and drawings for exact size, location, type, capacity etc. of the utilities required.|
|5.||Maintenance|| Supplier should provide the following maintenance instructions,
i. Operation and Maintenance manuals along with as built drawings
ii. Lubrication instructions
iii. Daily checks on machine
|6.||Inspection and Testing
Commissioning and Documentation
IQ/OQ/PQ to be completed by the supplier along with M/s Pharmaceutical Company representatives.
The Supplier to demonstrate the Performance of the machine at User site as per agreed terms.
The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.
Start up support
Post start up support
|Supplier to train the respective technical associates of Pharmaceutical Company on operation, maintenance and cleaning of the equipment wherever applicable.
Telephone / Fax / E mail ID / Address
Replacement parts availability list (normal lead times shall be listed)
System improvements (supplier shall notify user of any improvements)
|Any deviation from URS shall be highlighted|
| As per purchase order. To be delivered at
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube