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Designing effective User requirement
specification and Design qualification
1
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
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.
2
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.
3
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.
4
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.
5
• 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
6
7
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 .
8
• 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.
9
• 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 .
10
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.
11
12
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
13
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.
14
 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 )
15
16
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.
17
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 .
18
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
19
20

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Parag raj behura 190617006 designing effective urs and dq

  • 1. Designing effective User requirement specification and Design qualification 1 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. 2
  • 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. 3
  • 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. 4
  • 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. 5
  • 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 6
  • 7. 7
  • 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 . 8
  • 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. 9
  • 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 . 10
  • 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. 11
  • 12. 12
  • 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 13
  • 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. 14
  • 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 ) 15
  • 16. 16
  • 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. 17
  • 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 . 18
  • 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 19
  • 20. 20