Objective To lay down a procedure for User requirement specification (URS).
Scope This is applicable mainly to production equipment and utility systems. It shall also be applicable to analytical instruments and building facility with appropriate change or modification as applicable.
Responsibility Quality assurance, Engineering, Production and other user department
Procedure 4.1 Validation team member of user department shall prepare URS in consultation with Head of user department and technical team members based upon their identified requirements. 4.2 A template format as in Annexure I shall be used for URS preparation and shall be numbered as per SOP. 4.3 Following criteria shall be considered while preparation of URS: Pharmaceutical and regulation requirement Material of construction and finishing Operational and functional requirements Man machine interface Documentation 4.4 Pharmaceutical and regulatory requirement: 4.4.1 Head of user department shall check the regulatory requirement if any associated with the equipment / system. Wherever appropriate, consultants shall be referred to for their expertise and same shall be specified in the URS. 4.5 Material of construction and finishing: 4.5.1 All product contact surfaces of the processing and utility equipment shall be of SS 316. Finishing shall be smooth and easily cleanable. 4.5.2 Other contact component shall be of food grade material. The contact surfaces shall be smooth and easily cleanable. These materials shall not be reactive, additive or adsorbing so as to alter the safety, identity, strength, quality or purity of the drug product. 4.5.3 The non-contact surfaces wherever appropriate shall be SS 304. It shall be smooth and easily cleanable. 4.5.4 Seals in contact with the product shall be food grade. 4.5.5 Lubricant shall be of food grade quality wherever appropriate. 4.5.6 Wielding should be proper. 4.6 Operational and functional requirements: 4.6.1 Following general aspects shall be considered, as appropriate: Salient features of the system Description of the manufacturing process expected Quantities to be produced Expected process time Description of the environment in which the machine has to be installed Easy and quick disassembling and reassembling of parts to be cleaned List of emergency spare parts List of tools required for maintenance operations 4.7 Documentation: Following documents shall be requested from the supplier, as appropriate: Material traceability with respect to contact parts, non-contact parts, welds and finishing Mechanical, Electric and Pneumatic documentation Computer and PLC documentation Measuring instruments and maintenance documentation Preventive maintenance documents Instruction manual Conformity certificates 4.8 Measuring instruments and Maintenance documentation: Technical documentation for each instrument Calibration certificates from the instrument manufacturer 4.9 Maintenance documents: Maintenance procedures including controls and spare parts change frequencies List of lubricants and their associated specifications documentation Complete list of spare parts and list of associated suppliers with identification on diagrams List of emergency spare parts List of tools 4.10 URS shall also specify the testing levels for acceptance of the system or equipment, time line for completion of the activities and other specific contractual conditions. 4.11 The original signed document shall be kept with QA for attaching to final qualification document. Photocopies shall be given to user department and purchase department.
Abbreviations SOP: Standard operating procedure URS: User requirement specification QA: Quality assurance SS: Stainless steel