user requirement specification and design qualification

1. Designing effective User requirement
specification and Design qualification
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Guided by:
Dr. GIRISH PAI K
Faculty
Department of Pharmaceutics
MCOPS
Manipal Academy of Higher Education
Presented by:
PARAG RAJ BEHURA
Reg. No :190617006
M.Pharm (Industrial Pharmacy)
Department of Pharmaceutics
MCOPS
Manipal Academy of Higher Education

2. What is Validation
• According to the Food and Drug Administration (FDA),
“Establish documented evidence which provides a high degree of assurance that a
specific process will consistently produce a product meeting its predetermined
specifications and quality attributes.”
• It is a requirement for Good Manufacturing Practices and other regulatory
requirements.
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3. User requirement specifications
User Requirements Specification (URS), is the most critical of documents and yet,
the most often bungled. Whether the system is purely mechanical, or a mix of electro-
mechanical , or solely a software program, the successful compilation and execution
of the Installation Qualification (IQ) (for installation), Operational Qualification
(OQ) (for functionality) and the Performance / Product Qualification (PQ) (for
operability), is dependent on an User Requirements Specification (URS) containing
clear, concise and testable requirements.
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4. Advantage of URS
• Clarifies technical, quality, and documentation requirements to the vendor( s).
• Enables the pharmaceutical manufacturer to assess the technical, regulatory,
and commercial compliance .
• Ensures the basis of a structured approach to the presentation of information.
• Provides a basis for testing and test acceptance criteria.
• Provide a baseline for validation and verification.
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5. Guidelines for designing of URS
• Each requirement statement to be uniquely referenced, and no longer
than 250 words.
• Requirement statements should not be duplicated nor contradicted.
• Should express requirements and not design solutions.
• Each requirement should be testable .
• Must be understood by both user and supplier; ambiguity and jargon
should be avoided.
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6. • Use of diagrams is often useful.
• Scope for readers to make assumptions or misinterpret should be minimized.
• Should distinguish between mandatory/regulatory requirements and
desirable features
• For example : Octagonal blender
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8. URS Contents :
• Cover page : Company name and logo , project title , system identification
by name and number , issuing date and signature from all parts of the
approving team .
• Table of contents : A page reference with all numerated sections and
appendices .
• General : Aspect of the project such as use , locations , safety statements
and introductory section .
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9. • User specifications: It comprises of all possible technical and process related
issues such as batch sizes , manufacturing rates , material loading and unloading
features .
• Cleanability: Definitions of required cleaning methods and option such as
cleaning place . Separated as well as drainable features and additional side
storage tanks are part of the requirements .
• Automation : Internal company standards , instrumentation required for the
control parameters . Special features description such as alarm management ,
historical and bio data and access level definition for automatic processes.
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10. • Materials of construction : Specifications for surface finishing grades of direct
contact parts , gaskets and lubricants where necessary .
• Glossary : A straightforward list of all used acronyms in the entire text .
• Appendices: Technical and commercial appendices as part of the URS specify
site conditions of work , plant utilities , maintenance and piping requirements ,
electrical and safety standards , packing , in-voicing instructions and all non-
disclosure agreement conditions .
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11. Design qualification
• Design Qualification (DQ) defines the functional and operational
specifications of a balance or instrument.
• Details the conscious decisions made in the selection of the supplier .
• Should ensure that instruments have all the necessary functions and
performance criteria that will enable them to be successfully implemented
for the intended application and to meet user requirements.
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13. Steps that should be considered for Design Qualification.
• Description of the analysis problem
• Description of the intended use for the equipment
• Description of the intended environment
• Preliminary selection of the functional and performance specifications (technical,
environmental, safety)
• Preliminary selection of the supplier
• Final selection of the supplier and equipment
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14. The scope of the DQ must include but is not
limited to :
 Verification that the design will achieve the user specifications.
 Verification that the design is compliant with GMP.
 Verification that the design complies with the Validation Master Plan.
 Verification that the utility services required are available and validated.
 Verification that all the required support certificate is specified.
 Verification that the system can be calibrated.
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15.  Verification that the system can be maintained .
 Verification that the system will operate in a manner safe to both product
and staff.
 Verification that the system conforms to all applicable national standards
and guidelines .
For example : GLR (Glass liner reactor )
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17. Conclusion
• The DQ Procedures and expectations will vary from company to company
• Design firms , Vendors and other support resources for Pharmaceutical
manufacturers .Need to understand the client’s DQ needs and have systems and
methods adaptable to those needs .
• A particular URS describes a separate requirement specification should provide
appropriate production process and product information , electrical and
mechanical details and performance requirements.
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18. References
1.) Q7A Good Manufacturing Practice Guidance [Internet]. U.S. Food and Drug
Administration. 2020 [Accessed 6 March 2020]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-q7a-good-manufacturing-practice-guidance-
active-pharmaceutical-ingredient.
2.) Panchal D. Concept of URS,DQ,IQ,OQ,PQ [Internet]. Slideshare.net. 2020
[Accessed 6 March 2020]. Available from:
https://www.slideshare.net/dhavalrock24/concept-of-ursdqiqoqpq .
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19. 3) Donald M. [Internet]. 2020 [cited 6 March 2020]. Available from:
https://www.ispe.gr.jp/ISPE/04_cop/pdf/pharmaceutical_04_en.pdf.
4.) Design qualification in practice - From strategy to report by Chvaicer ,
Yossi
file:///C:/Users/dell/Downloads/05JA-Chvaicer%20(2).pdf
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