General Controls - GMP interpretation? General Requirements Concerning Records

Aphel

Involved In Discussions
#1
Hello,

I have a question regarding a the following FDA Statement:

"FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180)."

The last sentence contains ... "general requirements concering records (21 CFR 820.180)" ... now my question: What records are we talking about here?
Does the requirement mean, that there also has to be a Device Master Record and Device History record - or not?
I ask, because the requirement for DMR and DHR is defined in §820.181 respectivly §820.184 and not under §820.180.
Thats why I am little bit confused about the meaning of §820.180.

Can you explain this to me?

Thank you very much in advance for your help.

Best regards,
Aphel
 
Elsmar Forum Sponsor

sagai

Quite Involved in Discussions
#2
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hi Aphel!
Records are not only records are in the DHF, DMR, DHR but others are defined by 21CFR820.
For example, internal audit report, CAPA record, training record, etc.
The exact number of records relates to your question highly depends on how your QMS reflects to the requirements set forth by 21CFR820.
Regards
Szabolcs
 

Aphel

Involved In Discussions
#3
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hello sagai,

So in detail this means, that I do not need a dmr or a dhr for a gmp exempt class 1 medical device, right?

Best regards,
Aphel.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hello,

I have a question regarding a the following FDA Statement:

"FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180)."

The last sentence contains ... "general requirements concering records (21 CFR 820.180)" ... now my question: What records are we talking about here?
Does the requirement mean, that there also has to be a Device Master Record and Device History record - or not?
I ask, because the requirement for DMR and DHR is defined in §820.181 respectivly §820.184 and not under §820.180.
Thats why I am little bit confused about the meaning of §820.180.

Can you explain this to me?

Thank you very much in advance for your help.

Best regards,
Aphel
Can you please specify the exact quote's source?

Thanks,
Ronen.
 

Aphel

Involved In Discussions
#6
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hello everybody,

I still have no idea what records are meant in §820.180... in conjunction with GMP exempt class 1 medical devices...???

Is the GMP talking about every record out of §820 that is not part of the DMR and DHR?


Is there no one who can help... :-(

nice regards,
Aphel
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: General Controls - GMP interpretation? General Requirements Concering Records

Hello everybody,

I still have no idea what records are meant in §820.180... in conjunction with GMP exempt class 1 medical devices...???

Is the GMP talking about every record out of §820 that is not part of the DMR and DHR?


Is there no one who can help... :-(

nice regards,
Aphel
Hello,

The phrase you quoted is (as far as I understand) non-binding guidance. Look for the actual regulation language to understand what the GMP exemption includes / excludes, or formally contact the FDA to get a binding and definite answer.

Cheers,
Ronen.
 

sagai

Quite Involved in Discussions
#8
Re: General Controls - GMP interpretation? General Requirements Concering Records

I do not know.
I have note yet faced with this gmp exemption.
Regards
Szabolcs
 
D

Derrill Darby

#9
Re: General Controls - GMP interpretation? General Requirements Concering Records

I just found this topic while i was on a search so i am late to the discussion. Did you ever get an answer, i am searching for the same?

Thanks!
 
T

treesei

#10
Re: General Controls - GMP interpretation? General Requirements Concering Records

Here is how I interpret it: Even a company is exempted from cGMP, it still has a QMS and will still generate a lot of records (hard to believe it will not have inspection records, for example). Whenever there is a QMS related record, 820.180 applies. Does it need 820.181? Not formally. A normally operating manufacturer will still have at least part of the DMR content (product spec for example) but may not organize them or maintain them in a way 820.181 requires.

:2cents:Open to further discussion.:)
 
Thread starter Similar threads Forum Replies Date
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
D Preventive Maintenance vs. General Cleaning ISO 13485:2016 - Medical Device Quality Management Systems 2
Y What are different Special Inspection Level 1-4 and General spesification 1-3 ? AQL - Acceptable Quality Level 0
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
F General Data Protection Regulation (GDRP) CE Marking (Conformité Européene) / CB Scheme 6
D Importing a general wellness low risk product Other US Medical Device Regulations 3
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
G Problem Resolution Report Monitoring - Customer complaint or PRR as general motors use Customer Complaints 12
P Is there a counterpart to the General Safety and Performance Regulations for the USA? Other US Medical Device Regulations 2
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
M Informational WHO – Report by the Director-General – Standardization of medical devices nomenclature Medical Device and FDA Regulations and Standards News 0
J General Motors SSE Launch Algorithm - SCMS's Service Industry Specific Topics 0
D Incoming (Receiving) Inspection - General form for incoming part inspection Document Control Systems, Procedures, Forms and Templates 17
M Informational 2019 Meeting Materials of the General and Plastic Surgery Devices Panel Medical Device and FDA Regulations and Standards News 0
M FDA Guidance - general wellness products - wearables Other Medical Device Related Standards 3
MrTetris GDPR - General Data Protection Regulation - Only applicable to EU data? Other ISO and International Standards and European Regulations 6
M Informational The USFDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019 Medical Device and FDA Regulations and Standards News 0
M Oxygen enriched environment applicability - Operating table used in general surgeries in hospital IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Marc Definition GSPR - General Safety and Performance Requirements Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
M Annex I - General Safety and Performance Requirements. Precise identity - how provided EU Medical Device Regulations 6
E What is the general time line to prepare for IATF Letter of Conformance? IATF 16949 - Automotive Quality Systems Standard 1
S General Awareness Training for AS9100 Rev.D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B IVD or a general product test kit (if such a thing exists) EU Medical Device Regulations 0
L GDPR scope - "Personal data" definition - General Data Protection Regulation EU Medical Device Regulations 5
S GDPR (General Data Protection Regulation) - My company is ISMS certified IEC 27001 - Information Security Management Systems (ISMS) 3
S Business development and support - Getting business general liability insurance Career and Occupation Discussions 5
DietCokeofEvil What is the general consensus on Caliper tolerances? General Measurement Device and Calibration Topics 1
W EU GDPR General Data Protection Regulation - What we need to update for our QMS EU Medical Device Regulations 14
Y Change Control - General Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D General questions about Medical Device MOPs and MOPPs IEC 60601 - Medical Electrical Equipment Safety Standards Series 31
Albert G. What are general examples of audit findings with ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H ISO 9001:2015 Cl. 9.3.1 - General Director doesn't participate in Management Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T GDPR - General Data Protection Regulation (EU and UK 2018) Other ISO and International Standards and European Regulations 7
S AS9100D Transitional Audit General Question Checklist AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Dates on Labels acceptable to the USA - GS1 General Specification 3.4.4 Other US Medical Device Regulations 3
K Thoughts on the impact of the General Data Protection Regulation? Medical Information Technology, Medical Software and Health Informatics 5
Pmarszal Clarification for 21 CFR Part 11.100 - General Requirements Other US Medical Device Regulations 14
T Difference betwee General vs. Follow-up Inspections US Food and Drug Administration (FDA) 3
L Wrist Actigraph Device - IEC 60601-1 general questions IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C When is a device considered "sold to the general public?" Canada Medical Device Regulations 2
C Iran - Who is holder of an Iranian registration in general? Other Medical Device Regulations World-Wide 2
V General Full Factorial - Optimal Design Six Sigma 2
R General ISO/TS16949:2009 Implementation Primer Needed IATF 16949 - Automotive Quality Systems Standard 2
W DIN ISO 1101 - Show me the General Dimensioning Tolerance Value Other ISO and International Standards and European Regulations 3
Marc General Motors - 3D Scanning the Competition World News 2
J General QMS questions in regard to Medical Software ISO 13485:2016 - Medical Device Quality Management Systems 8
P Lot Acceptance Plan that specifies BS 6001 Double Sampling Plans, general inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1

Similar threads

Top Bottom