The pharmaceutical industry unlike other industries is highly regulated and requires dedicated processes and control for every part involved in product manufacturing. User Requirement Specification is also one of the many parts, used to describe the requirements of the required pharma equipment. It helps a Pharma manufacturer to define its requirements to achieve specific goals with that equipment. Without a comprehensive URS, it is impossible to accurately and completely convey the requirements to the machine manufacturer.
URS also serves as a base for fulfilling quality requirements related to the equipment such as validation and qualification. Additionally, it also helps to solve any dispute that could arise at a later stage between the manufacturer and the buyer.
What is the URS
User Requirement Specification is an official document that describes the requirements of a buying organization, expectations, and needs it intends to fulfill from that particular equipment. It contains the details of all specifications and functionality of the new machine.
URS contains input from all relevant departments such as Quality, Engineering, and Production. These departments give their input to fulfill their specific departmental requirement. It also acts as a benchmark for later activities such as validation and commissioning.
URs also serve to fulfill different regulatory requirements because every regulatory body emphasizes a proper and documented form to describe and state requirements. It must also be an official document that can act as a decisive factor, internally and externally.
It is prepared by taking input from all relevant stakeholders. After finalization, it is approved and sent to the machine manufacturer for their input and feedback. After the URS is agreed upon for both the machine manufacturer and buyer, machine manufacturing is started.
Regulator regulations
User Requirement Specification is the regulatory requirement for major markets such as the United States and Europe. They review the URS, during their routine inspection, and can issue a warning, if a well-documented URS is not presented to them.
Let’s discuss some regulatory regulations for the United States and Europe
United States FDA
The United States FDA does not explicitly use the term URS but emphasizes defining the machine requirement, which is achievable by a URS.
The US FDA regulation, 21C FR 2 11 subpart D and section 211.63 “Equipment Design, Size, and Location”, states that
Equipment used in manufacturing must be of suitable design.
For equipment to have a suitable design, it first requires to define its requirements, which can be easily achieved by an appropriate URS
There is another guideline that is intended for software validation, known as “General principles of software validation; final guidance for industry and FDA staff”.
Section 6.2 states that the URS must be devised defining the intended use of software to an extent to which the manufacturer is dependent on the software
EU GMP
EU GMP are the regulatory guidelines for drug products in Europe and also provide a reference to the User Requirements Specification in the following
EU GMP Annex 15
Annexure 15 of the EU GMP is called Qualification and Validation, it states that the URS should include the specification for equipment, facilities & utilities, and must be quality-focused. If there are any chances of any deviation it must be mitigated at this stage. Additionally, the URS be a reference document throughout the validation activity, i.e. acceptance criteria should be set according to the specification mentioned in the URS
In another annexure of EU GMP “Annexure1: Manufacture of Sterile Medicinal Products”. In its sub-part “Equipment” the requirement of URS is described as
“Equipment monitoring re...
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