To lay down the procedure for User requirement specification of the Equipments / Instruments/Systems.
1.0 PURPOSE
To lay down the procedure for User requirement specification of the Equipments / Instruments/Systems.
2.0 SCOPE
2.1 This procedure is applicable in All departments
3.0 RESPONSIBILITY
3.1 Validation - Coordinator
4.0 ACCOUNTABILITY
4.1 Manager - Quality Assurance
5.0 PROCEDURE
5.1 The User requirement specification protocol will be as detailed as possible to avoid later confusion over any aspect that was not previously documented. The records can be used as a basis for comparison for proposed changes.
5.2 The protocol consists of the following information in the respective cells of the format given in Annexure-I
|
Cell Number |
Information |
Font |
|
01 |
To write the equipment/System name |
Upper case |
|
02 |
To write the user department name |
Upper case |
|
03 |
To write the protocol number |
Upper case |
|
04 |
To write the effective date of the protocol |
Numeric |
|
05 |
To write the name of the Block |
Upper case |
|
06 |
To write the name of the module |
Upper case |
5.3 The contents of the Protocols shall be as follows
5.3.1 TABLE OF CONTENTS
5.3.1.1 Process / Product Requirement
5.3.1.1.1 In this section Name , Purpose and Number of
equipments, Facility required shall be mentioned
5.3.1.1.2 Process description and schematic flow diagram
shall be descried.
5.3.1.1.3 Chemical and physical characteristics of the
process material handled in the subjected
equipment shall be mentioned.
5.3.1.1.4 Capacity, Model required and Name of the
Suppliers(if any) shall be mentioned.
5.3.1.1.5 Any other specific requirement also shall be
mentioned.
5.3.1.2 Operational requirements
5.3.1.2.1 Production stage or exact usage in which the equipment / system / facility operates shall be mentioned here.
5.3.1.2.2 Material input , desired output, batch size/Lot size/Charge size shall be mentioned.
5.3.1.2.3 Loading, unloading, cleaning and sanitation methods shall be mentioned.
5.3.1.2.4 Expected operational hours per day, required utilities, Process control requirements, desired level of instrumentation Change over parts requirement and Connectivity equipments shall be mentioned
5.3.1.2.5 Room dimensions and any other specific requirements shall be mentioned.
5.3.1.3 GMP requirements
5.3.1.3.1 Equipment’s material of construction,
requirement on working area environment,
avoiding contamination and cross contamination
shall mentioned.
5.3.1.3.2 Any other GMP requirement also shall be
mentioned.
5.3.1.4 Safety requirements
5.3.1.4.1 Desired safety systems of Product / Process, Desired personnel safety systems and any specific requirement with respect to safety shall be mentioned.
5.3.1.5 Documentation requirements
5.3.1.5.1 Documents required such as drawing,
Certificates, Operation and Maintenance manual,
Major component list shall be mentioned.
5.3.1.6 Discussion / Review / Comments
5.3.1.6.1 The overall review and comments of the user
requirement specification shall be mentioned.
5.4 Preparation of the user requirement specification protocol is as per Annexure-I
5.5 After the approval of user requirement specification, data sheets shall be prepared.
5.6 These data sheets shall have detailed specifications of equipment / facility/
System including Pre-dispatch inspection tests, design sketch and list of
documents required for qualification.
5.7 Preparation of data sheet is as per Annexure – II
5.8 The Data Sheet consists of the following information in the respective cells of the format given in Annexure-II
|
Cell Number |
Information |
Font |
|
01 |
To write the equipment/System name |
Upper case |
|
02 |
To write the Equipment Number |
Upper case |
|
03 |
To write the protocol number |
Upper case |
|
04 |
To write the effective date of the protocol |
Numeric |
|
05 |
To write the Revision Number |
Numeric |
|
06 |
To write the name of the Block |
Upper case |
|
07 |
To write the name of the Module |
Upper case |
END OF DOCUMENT
User requirement, specification, quality assurance
