User specifications requirements

1. URS-USER REQUIREMENT SPECIFICATIONS
Presented by
Girija G S
M PHARM 1ST SEM
DEPARTMENT OF
PHARMACEUTICS
MALLIGE COLLEGE OF
PHARMACY
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USER REQUIREMENT SPECIFICATIONS-URS
→ Requirements regarding equipment is given by users called as
URS.
It includes,
 Size of equipment
 Speed of equipment
 Effectiveness of equipment
 Availability of spares, change parts
 Low dust and sound facilities
 Auto control systems
 Lesser breakdowns
 Overall good construction

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 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
pharmaceutical manufacturer.

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The following guidelines should be followed during the production of
the URS:
 Each requirement statement to be uniquely referenced, and no
longer than 250words.
 Requirement statements should not be duplicated nor
contradicted.
 The URS should express requirements and not design solutions.
 Each requirement should be testable.

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 The URS must be understood by both user and supplier; ambiguity
avoided.
 The use of diagrams is often useful
 Wherever possible, the URS should distinguish between
mandatory/regulatory requirements and desirable features.

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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
volumes, namely:
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

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URS provides the following key benefits for the validation program:
1. Clarifies technical, quality, and documentation requirements to the
vendor(s).
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
information.
4. Provides a basis for testing and test acceptance criteria.
5. Provide a baseline for validation and verification..

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Model Question
1) Write a note on
USR?

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References
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

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