GMPs (Good Manufacturing Practices) in IND (Investigational New Drug) Study

H

HPLC_Help

#1
Hi, all -

This might be a little confusing ...

My company is planning an IND study on a Blood Donor Screening Assay. These assays are regulated as Medical Devices.

It is clear the 21CFR820 regulations apply to the GMPs/Quality System for the manufacture of our assay kits.

Our IND study includes running x number of samples through our assay. So what regulations describe the necessary GMPs and Quality System for the actual running of the assay as part of the IND??

I'm sure in many ways they are similar, but I am performing a Gap Analysis of our current processes and the GMP requirements, and I'd like to be able to reference exact QSR sections when I provide feedback.

It's easy to say "we didn't use the correct revision of the SOP describing manufacturing our kit, so we didn't comply with 820.40 (a)." But if we used the wrong revision of an SOP used in running the samples in the IND, what regulation did we miss?

I've been searching the FDA website, but I obviously haven't entered the magic combination of keywords to get the answer I need.

Thanks. And please let me know if I'm making this far more complex than it has to be.

H_H
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

As far as I understand, if it's regulated as a medical device then anything related to the development process is covered under 820.30 - Design Controls, unless the applicable 3-letter product code exempts. 820.30 is not very specific with regards to running tests.

Cheers,
Ronen.
 
H

HPLC_Help

#3
Thanks for the input Ronen E.

I have a phone call with a consultant today who may clear this up. If so, I'll post what I find out.

H_H
 
H

HPLC_Help

#4
Follow up:

The manufacture/assembly/instructions for the assay are reviewed against 820 (and a few others, but mainly that one.) The use of the assay for the IND is reviewed against what was stated in the IND document - that is, did we do what we said we were gonna do.

Thanks, all!

H_H
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Follow up:

The manufacture/assembly/instructions for the assay are reviewed against 820 (and a few others, but mainly that one.) The use of the assay for the IND is reviewed against what was stated in the IND document - that is, did we do what we said we were gonna do.

Thanks, all!

H_H
:confused:

As much as I understand, IND relates to Drugs (a certain exemption from drug regulation requirements). Is your assay considered a drug? If so, how is it also considered a medical device? I thought it's an IVD, but I'm not sure -- is it intended to detect diseases, conditions, or infections?
 
H

HPLC_Help

#6
Good questions, Ronen.

Our assay screens blood from potential donors, and so it falls under an IND. (As I understand it, the FDA wanted to have a system for testing such assays on patients, so since the IND process was already established ...). Since the test kits are manufactured, it falls under the Medical Device rules (820). Also, there are blood-donor specific regulations under the 21CFR 600's that require our attention, too. I've heard that folks in the blood donation/processing industry are pushing the FDA to draw up simpler guidelines - that is, have a set of rules just for blood donor screening assays - but the way it stands now, we have to try to comply with everything. Sort of ...

Let's just say I'm glad I have knowledgeable, experienced consultants to guide me through this maze.

H_H
 
Thread starter Similar threads Forum Replies Date
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
J Do Cosmetic GMPs apply for Fragrance Manufacturer US Food and Drug Administration (FDA) 1
V GMPs - Comparison for Drug Products vs. Food Products vs. Dietary Supplements US Food and Drug Administration (FDA) 0
V Similarities and Differences between EU & US GMPs (Good Manufacturng Processes) Document Control Systems, Procedures, Forms and Templates 8
T Special accommodations to certain cultures - Hair nets - GMPs Food Safety - ISO 22000, HACCP (21 CFR 120) 7
T Comparison of EU and US GMPs - Differences applying CFR211 or the EU GMPs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
S CE and Manufacturing license Manufacturing and Related Processes 1
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
P How to measure DPPM in Chemical batch manufacturing Quality Tools, Improvement and Analysis 1
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
K One CE Mark holder - multiple manufacturing sites EU Medical Device Regulations 3
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 12
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
S Manufacturing Execution Systems Software Costs Manufacturing and Related Processes 0
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
DuncanGibbons Additive Manufacturing Processes Thread Manufacturing and Related Processes 5
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
H Line Balancing in Backpack Manufacturing Manufacturing and Related Processes 2
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L SAE AS9145 vs. SAE AS6500 (Manufacturing Management Program) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 5
qualprod Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Z US Manufacturing Site Closing, device manufactured elsewhere Medical Device and FDA Regulations and Standards News 1
L Manufacturing site expansion - When to notify your NB EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom