Design History File DHF Practices and Contract Manufacturer

R

RLKESTER

#1
#1
Looking for others experience regarding DHF practices when using contract manufacturer to create a part to meet a specification. For example a catheter shaft is a specified material, dimensional and physical characteristics. The specification does not state specific process / mfg / Test requirements and intended use is generically stated. What obligation is put to the contract mfg toward the DHF?

If the word Process is substituted for Design would it guide the Contract Mfg process more effectively? For example: creation of a PHF that had Process FMEA, Process Design Review, Process development history, Process validation, etc? Is there a similar corollary in pharma?

Your thoughts please
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Moderator
#2
#2
RLKESTER said:
Looking for others experience regarding DHF practices when using contract manufacturer to create a part to meet a specification. For example a catheter shaft is a specified material, dimensional and physical characteristics. The specification does not state specific process / mfg / Test requirements and intended use is generically stated. What obligation is put to the contract mfg toward the DHF?

If the word Process is substituted for Design would it guide the Contract Mfg process more effectively? For example: creation of a PHF that had Process FMEA, Process Design Review, Process development history, Process validation, etc? Is there a similar corollary in pharma?

Your thoughts please
Click to expand...
Hello and welcome to the cove :bigwave:

Honestly, your post got me a bit confused...:confused:

If you're trying to comply with part 820, you can't just make up your own "parallel" terminology; you have to stick to the FDA's terminology and meet the relevant requirements. I am not aware of a "PHF" or "Process development history", though process FMEA and process validation do fall into their places in the QSR.

To the point, unless you have a private labeling arrangement with the contract manufacturer and a contract that states otherwise, you bear full regulatory responsibility, and unless design controls exempt, you have full responsibility for the DHF compilation and contents (the CM nevertheless could provide expert content that you may lack). In short, in such settings the CM does not have any obligations re. the DHF, other than those spelled out in the contract between you and them.

I can't but wonder - if the process AND acceptance testing requirements aren't specified, how can you determine that the conponent is acceptable?

Cheers,
Ronen.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Audit Finding - Design History File (DHF) Index: few (3 to 4) reports not identified ISO 13485:2016 - Medical Device Quality Management Systems 3
K Design History File - Looking for Examples of DHF's. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
R No design history file or device master record ISO 13485:2016 - Medical Device Quality Management Systems 5
R Suggestions for putting together a DHF (Design History File) ISO 13485:2016 - Medical Device Quality Management Systems 3
D Questions about the contents of a Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Template / format for Device History File & Design Verification of transdermal patch 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
JoCam Ownership of Design History File EU Medical Device Regulations 6
K ISO 13485 and DHF (Design History File) requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
M Design History File (DHF) for New Generation of Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N 510k without DHF (Design History File) that we bought a 3 years ago US Food and Drug Administration (FDA) 4
A DHF (Design History File) for a Legacy Product (Class iii Medical Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B When To Share Your DHF (Design History File) With A Customer US Food and Drug Administration (FDA) 1
S Cost Targets as Design Inputs in your DHF (Design History File) US Food and Drug Administration (FDA) 7
C Should Research Findings be in the Design History File? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
renenatasha Usage of web articles in DHF (Design History File) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A Medical Device DHF (Design History File) - One per Design Change? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
L Creating DHF (Design History File) for Medical Device Systems Design and Development of Products and Processes 8
O ISO Standards For Intramedullary Pin Design History File Other Medical Device Related Standards 2
K How to start a Design History File (DHF) for Medical devices Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Design History File (DHF) - Buy-For-Resell Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A Design History File Maintenance - Who is responsible for the Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M What are typical Roles & Responsibilities of DHF (Design History File) Librarian? US Food and Drug Administration (FDA) 6
H Paper based DHF (Design History File) updates for Software Updates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Who should document the Design Review Meeting and Design History File? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Q DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 50
C Remediating a Design History File (DHF) for an IVD developed prior to 1997 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Design History File (DHF) Maintenance Information wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
O DHF (Design History File) Template Other US Medical Device Regulations 13
C How to establish a Design History file (DHF)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
W Design History File (DHF) Template Example for Consideration. Design and Development of Products and Processes 12
S Which documents in the DHF (Design History File) should be controlled? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q DHF (Design History File) on New Medical Device Product ISO 13485:2016 - Medical Device Quality Management Systems 9
M Design History File - Medical Device Quality Systems Manual Section 3, Design Control Design and Development of Products and Processes 1
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
N Design Validation Conventions for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Design history files for combination products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Maintaining Component Traceability in DHR (Design History Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Medical Device Service Records linked to DHR (Design History Record)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Better control of DHR (Design History Record) during processing Document Control Systems, Procedures, Forms and Templates 5
R Cloud Computing Requirements for Design History Files for Software Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M DHR (Design History Record) Requirements - Concessions Quality Manager and Management Related Issues 12
W Design History Verification Records Control and Approvals US Food and Drug Administration (FDA) 3
A Is a Distributor responsible for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
H Working from a previous design history. How can I best leverage the exisitng DHF? Other US Medical Device Regulations 4
X Design stage overview (Product specification) EU Medical Device Regulations 3
gohyl Fixture Setup Design Manufacturing and Related Processes 3
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 2
T Software item classification and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 4

Similar threads

Top Bottom