USER REQUIREMENT SPECIFICATIONS-URS
→ Requirements regarding equipment is given by users called as
Size of equipment
Speed of equipment
Effectiveness of equipment
Availability of spares, change parts
Low dust and sound facilities
Auto control systems
Overall good construction
The requirement and specifications for the utility of equipment
should be defined by the user and documented in the URS.
The URS should be used when selection of the required utility
or equipment from an approved supplier and to verify suitability
throughout the subsequent stages of qualification.
They must be comprehensive. Each and every requirement relating to product safety,
identity, strength, purity, and quality must be identified.
The URS can contain a large number of requirements and should therefore be
structured in a way that will permit easy access to information.
The requirement specification must be formally reviewed and approved by the
The following guidelines should be followed during the production of
Each requirement statement to be uniquely referenced, and no
longer than 250words.
Requirement statements should not be duplicated nor
The URS should express requirements and not design solutions.
Each requirement should be testable.
The URS must be understood by both user and supplier; ambiguity
The use of diagrams is often useful
Wherever possible, the URS should distinguish between
mandatory/regulatory requirements and desirable features.
U.R.S. for facilities is a statement spelling out, what the user wants in terms
of the facilities, he wants to create for the manufacturing of the
pharmaceutical formulations. It can expressed in the following manner.
The facility will be used for the manufacture of the following formulation and
1) Tablets-Coated 10L/Shift
2) Tablets-Uncoated 20L/Shift
3) Hard gelatin capsules 5L/Shift
4) Small volume parenterals 50K Amp/Shift
5) Large volume parenterals 20Kbottles of 500 ml/Shift
URS provides the following key benefits for the validation program:
1. Clarifies technical, quality, and documentation requirements to the
2. Enables the pharmaceutical manufacturer to assess the technical,
regulatory, and commercial compliance (or otherwise) of submitted
bids against a formal specification.
3. Ensures the basis of a structured approach to the presentation of
4. Provides a basis for testing and test acceptance criteria.
5. Provide a baseline for validation and verification..
Pharmaceutical Process Validation, Second Edition, Revised and
Expanded, edited by Ira R. Berry, Robert a. Nash.
Validation in pharmaceutical industry; Equipment validation; A brief
review, Diksha Jindal, et al; Adesh University Journal of Medical
Sciences & Research. www.aujmsr.com