| SOP on Preparation of User Requirement Specification (URS) for Quality Control Instruments |
1.0 OBJECTIVE 1.1 To lay down the procedure for preparation of User Requirements Specification (URS) for Quality Control instruments. 2.0 SCOPE 2.1 This procedure shall apply to the preparation of User Requirements Specification of critical equipment / instrument / system under consideration for acquisition. This procedure for preparation of URS shall also be applicable for any equipment / instrument / system undergoing major modification, or in case any add-on features are added to the existing equipment / instrument / system. The contents of the URS mentioned in this SOP are illustrative and can be differed as per the specific requirement of Quality Control Department of XXX. This Standard Operating Procedure is applicable in Quality Control Department. 3.0 RESPONSIBILITY 3.1 All users are responsible for preparation of URS. 4.0 ACCOUNTABILITY 4.1 Head-QC 5.0 PROCEDURE 5.1 User requirement specification is a document describing the user requirements; those are expected from the equipment /instrument /system under consideration for acquisition. 5.2 The user shall intimate to the Head-QC for the intensions for acquiring the equipment / instrument /system. 5.3 URS shall be initiated by the user after the assessment is made by the HOD that the equipment / instrument / system under consideration for acquisition requires the URS. The assessment by HOD shall be done based on the criticality of the equipment / system / equipment under consideration for acquisition. 5.4 The assessment of the equipment / instrument / system under consideration for acquisition, for preparing the URS shall be based on the following criteria which shall be considered as critical: 5.4.1 The equipment / instrument / system under consideration for acquisition can have an impact on product quality (e.g. analytical balances, etc.) 5.4.2 The equipment / instrument / system under consideration for acquisition is being proposed to be used for assessing the product quality (e.g. HPLC, UV spectrophotometer etc.) 5.5 The URS protocol for the equipment / instrument / system under consideration for acquisition shall be prepared (A), reviewed (B) and approved (C) for implementation by authorized personnel from the following departments in general: 5.5.1 The URS shall be prepared by (A) user department. 5.5.2 The reviewer (B) shall be reviewed by Head QC. 5.5.3 The approver (C) shall be Head QA or management. 5.6 Title of URS document shall be mention as User Requirement Specification of – Name of Equipment / Instrument. E.g. if URS of refractometer is to be prepared, then the document title in document shall be mentioned as User requirement Specification of Refractometer. 5.7 A unique document no. shall be given to each URS document as follows: URS/QC/001 Where, URS : User requirement specification / : For separation QC : Quality control / : For separation 01 : Serial number starting from 001 5.8 This URS numbering shall be logged in format number XXX. 5.9 The URS shall mention the Operational Requirements, but not limited to, as following: 5.9.1 Describe the capacity. 5.9.2 Material of construction (MOC). 5.9.3 Product limitations (i.e. temperature, humidity, pH, etc.). 5.9.4 Details of the operator interaction level i.e. manual, semiautomatic, automatic. 5.9.5 Power failure / recovery system and protection priority. 5.9.6 Critical Alarms and Warnings list. 5.9.7 System requirements like the temperature and relative humidity, etc. 5.9.8 List of documents to be provided. 5.10 Prepare the URS document as per format number XXX. 5.11 Note: This is the general requirement; the operational requirements can be changed as per requirement. 6.0 ABBREVIATIONS 6.1 SOP : Standard operating procedure 6.2 QC : Quality Control 6.3 HPLC : High performance liquid chromatography 6.4 URS : User Requirement Specification 6.5 HOD : Head of department |
