SOP for User Requirement Specification in Pharmaceutical Industry
To lay down a procedure for User requirement specification (URS).
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.
Quality assurance, Engineering, Production and other user department
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
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
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.
SOP: Standard operating procedure
URS: User requirement specification
QA: Quality assurance
SS: Stainless steel