Design Controls for Combination Drug Product Manufacturer (ANDA)

v9991

Trusted Information Resource
#1
We intend to manufacture drug device combination product; ( basically assembling of the product is what is done at our facility; very-roughly, drug solution is filled into a component and capped )

  • design of the product is look-alike to that of innovator. ( device design to be same as that of innovator, reference listed, FDA-approved product);
  • There are specific criteria for drug product performance which will be demonstrated (verified & validated)

Now my question is about the details covered in 820.30 Design Controls
option -1 :- not relevant for our manufacturing facility ( Design controls established at component-suppliers is adequate)
option -2 :- design controls of individual components (referenced to respective suppliers-documentation) and the controls for assembling process to be maintained.
Option -3 :- design controls for assembling process to be maintained. ( individual components would be directly filed with FDA and only a reference document Number is cited)
 
Elsmar Forum Sponsor

v9991

Trusted Information Resource
#2

Attachments

Last edited:

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Thanks for coming back and letting us know what you found out. Sorry no one here could help.
 
Thread starter Similar threads Forum Replies Date
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
shimonv 'Beta testing' & Design Controls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S Audit checklist for "Design Controls" per ISO 13485 wanted Internal Auditing 3
J The application of Design Controls to IVDs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Importance of Medical Device Accessory Design Controls Other US Medical Device Regulations 4
T 21 CFR Part 820.30 Design Controls for Class 1 Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
somashekar Exclusion of Design and Development Controls for Class 2B Medical Devices EU Medical Device Regulations 8
J Class II Medical Device Design Revision Controls ISO 13485:2016 - Medical Device Quality Management Systems 7
S Design Controls - Requirements - Specification - Trace Matrix 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L Does 820.30 Design Controls apply to Unclassified Device with 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Ajit Basrur Design Controls for medical device exported from China China Medical Device Regulations 5
B What, if any, Design Controls are needed for a Class I manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Le Chiffre 510(k) Changes: More bench testing and stricter design controls? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Info needed for a 510k of a high-pressure line? Especially Design Controls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Q Exclusion of Design and Development Controls - ISO 13485 Section 1.2 Design and Development of Products and Processes 6
D Health Canada Class II devices - exempt from design controls? Section 7 of 13485 Design and Development of Products and Processes 3
R How to rank Detection for Existing Preventative design controls FMEA and Control Plans 7
C Medical Device: QSR and Clinical Trials and Design Controls ISO 13485:2016 - Medical Device Quality Management Systems 3
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 1
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 1
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
L Design & Development of a SERVICE Service Industry Specific Topics 13
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A AS9102B - 3.6 Design Characteristics and form 3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design Input detail & specificity ISO 13485:2016 - Medical Device Quality Management Systems 4
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
R Design and Manufacture Guidelines for Surface Mount Technology Misc. Quality Assurance and Business Systems Related Topics 9
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom