Quarterly Dose Audit Medical Device VDmax

alonFAI

alonFAI

Involved In Discussions
Hello All,

Dear All, I have a number of question regarding VDmax quarterly dose audit:

1. Why do I need ,technically speaking to perform a quarterly dose audit?
if I perform a Bioburden routinely and my CFU<X then wouldn't it mean that my product is sterile? why a dose audit is still required?

2. is it possible that the level of CFU on my product is still within acceptable limits (CFU<X) but the sterility of the product would be compromised some how? maybe due to a change in the type of microbes? (gram stain, maldi tof)?

3. lets say I manufacture a certain product in 2 different contract manufacturers.
these products are then sterilized in 2 different sterilizers.
sterilization dose is the same.
would I need to perform a quarterly dose audit for "both products" (i.e. perform a dose audit on items produced by Contract manufacturer 1 and on items produced by contract manufacturer 2 as well?) (these are identical products just manufactured by 2 different contract manufacturer according 3. to same spec)?

4. Where should I perform the quarterly dose audit? must it be done by the sterilizer itself? or I can work with any other lab capable of doing sterility test?

THANKS!!!:applause::bigwave:
 
P

pkost

Trusted Information Resource
I'm not an expert on this, but will add my thoughts

1. Why do I need ,technically speaking to perform a quarterly dose audit?
if I perform a Bioburden routinely and my CFU<X then wouldn't it mean that my product is sterile? why a dose audit is still required?
Click to expand...

I believe this demonstrates that the process (both manufacture and sterilisation) is repeatable and stable;. from recollection, after a year you can justify droping down the dose audits to annual


2. is it possible that the level of CFU on my product is still within acceptable limits (CFU<X) but the sterility of the product would be compromised some how? maybe due to a change in the type of microbes? (gram stain, maldi tof)?
Click to expand...

VDmax validates against your bioburden type, if it changes significantly, your valdiation is no longer valid


3. lets say I manufacture a certain product in 2 different contract manufacturers.
these products are then sterilized in 2 different sterilizers.
sterilization dose is the same.
would I need to perform a quarterly dose audit for "both products" (i.e. perform a dose audit on items produced by Contract manufacturer 1 and on items produced by contract manufacturer 2 as well?) (these are identical products just manufactured by 2 different contract manufacturer according 3. to same spec)?
Click to expand...

the different sites will have different handling/bioburden etc...from recollection the standard includes parameters that impact the validation...site, bioburden, process etc...

Both sites should probably be validated seperately


4. Where should I perform the quarterly dose audit? must it be done by the sterilizer itself? or I can work with any other lab capable of doing sterility test?
Click to expand...
I believe the work can be done anywhere
 
K

Kees Fremerij

Starting to get Involved
This is called ¨maintaining process effectiveness¨. Is everything still under control like bioburden, production environment, product handling, packaging and so on. That is why it is required to check this periodically, every 3 months. Historically this period was to eliminate seasonal influences. Nowadays this is not such a big issue anymore in most production environments.
Once all appear to be stable and under control you can lower the frequency to maximum once a year. You can write a rationale which covers all the actions required. (I wrote several of these, it is not very complicated if you know where to look at).

If you have a stable and low Bioburden the change of failure in a Dose Audit is very small. But the purpose of this Dose Audit is exactly to cover that. For the Bioburden it is not only in numbers but also the types of bacteria which is relevant.

Production at different locations automatically implicates different validation studies as the external risks are not equal. Again, after proven stability a rationale can be a solution to reduce this.

Any accredited Microbiological Lab (preferable ISO 13485 certified) should be able to perform the tests.

So I completely agree with the previous comments...
 
C

Cristiane

Registered
Kees Fremerij: Could you pass a model of justification for changing the dose audit frequency? I'm having a lot of trouble.
 
chris1price

chris1price

Trusted Information Resource
Take a look at ISO11137-1, section 12.1.3 Frequency of sterilization dose audits. This will tell you what you need to do.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Quarterly Dose Audit Medical Device and FDA Regulations and Standards News 5
N Gamma Validation vs. Quarterly Dose Audit Differences ISO 13485:2016 - Medical Device Quality Management Systems 3
I Quarterly Gamma Dose Audit Question Other Medical Device Related Standards 4
T Missed Quarterly Dose Audit! Sterilization Validation of Medical Devices Other Medical Device and Orthopedic Related Topics 15
M Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 11137 Other Medical Device Related Standards 8
P Quarterly Dose Verification for e-beam Sterilization Question ISO 13485:2016 - Medical Device Quality Management Systems 1
K Gamma Ray Sterilization Quarterly Dose Auditing Supplier Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
B Gamma Quarterly Audit Medical Device and FDA Regulations and Standards News 1
B Oracle Cloud ERP Validation during Quarterly Patch ISO 13485:2016 - Medical Device Quality Management Systems 1
I Quarterly to semiannual audit of irradiation sterilization Qualification and Validation (including 21 CFR Part 11) 2
R Accurate Quarterly Inventory Turn Numbers Quality Manager and Management Related Issues 3
V Management Review - Not all items covered during quarterly review. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Call for Articles - CMM Quarterly Magazine The Reading Room 3
Marc CMM Quarterly - The making of musical instruments Book, Video, Blog and Web Site Reviews and Recommendations 0
O Quarterly Review with Suppliers - Discussion topics Supplier Quality Assurance and other Supplier Issues 1
GStough Internal Audit Frequency Schedule: Monthly, Quarterly, or Bi-Annually? Internal Auditing 46
Marc GM plunges into $1bn quarterly loss World News 28
CarolX Quarterly vs. Yearly Internal Audits Internal Auditing 15
B Gamma Irradiation - Multiple doses to achieve the Dose range 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Gamma Irradiation - Min and Max dose ISO 13485:2016 - Medical Device Quality Management Systems 0
chris1price Irradiation site for dose audit Other Medical Device Related Standards 2
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
Judy Abbott Increase the maximum allowable dose for E-beam sterilization Reliability Analysis - Predictions, Testing and Standards 2
E Unit Dose Packaging Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M Informational MHRA Guidance – Dental radiographic X-ray imaging: dose to patients Medical Device and FDA Regulations and Standards News 0
K Calibration of Dose Area Product (DAP) Meter in our Class IIb X-Ray Medical Device General Measurement Device and Calibration Topics 1
F Irradiation Sterilization Validation Maximum Dose - VDmax 25 method (ISO 11137) EU Medical Device Regulations 3
B Radiation Sterilization Dose Audit: Bioburden frequency Other Medical Device Related Standards 3
R ISO 11137 Gamma sterilization validation, dose setting, dose audit Other Medical Device Related Standards 1
H Change of a medical device sterilization dose - New 510(k) necessary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
H Gamma Irradiation - dose audit and source replenishment Other Medical Device Related Standards 18
K Bioburden 0 cfu for Dose Setting using the VDmax25 Other Medical Device Related Standards 9
M ISO 11137 - Verification dose audit for VD max method Other Medical Device Regulations World-Wide 7
R Irradiation Sterilization Dose Setting and Dose Audit Flow Charts ISO 13485:2016 - Medical Device Quality Management Systems 0
C Dose Mapping - How to relate back to Routine Monitoring Position ISO 13485:2016 - Medical Device Quality Management Systems 3
S Dose Consistency of Insulin Formulations ISO 13485:2016 - Medical Device Quality Management Systems 7
M Setting Solid Dose Drug Fill Count Ranges Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
A Help needed for Fighting a specifically identified Organism found during Dose Audit Miscellaneous Environmental Standards and EMS Related Discussions 2
E Auditing sterilization dose substantiated Vdmax 25 Other Medical Device Related Standards 4
G Dose Audit Requirements Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 7
E ISO 11137 gamma sterilized device dose audit - Lead time? Other ISO and International Standards and European Regulations 7
T Sterilization Dose Audit - Recommended Quantity of Samples/Batches ISO 13485:2016 - Medical Device Quality Management Systems 1
M Pharmaceutical Non conformances SOP - Solid oral dose start up company Nonconformance and Corrective Action 2
J Nuclear Medicine Dose Calibrator Classification (MDD) ISO 13485:2016 - Medical Device Quality Management Systems 5
P Customer ISO13485 Audit - Changing Agenda ISO 13485:2016 - Medical Device Quality Management Systems 10
E VDA 6.3 External audit - opening meeting VDA Standards - Germany's Automotive Standards 4
Q Leveraging Audit Report from Previous Job ISO 13485:2016 - Medical Device Quality Management Systems 14
K Need Help With IATF 16949 Audit NC IATF 16949 - Automotive Quality Systems Standard 6
D Opinions on internal audit schedule adjustment Internal Auditing 15
T What should be considered or asked to certified body auditors before selecting them for AS9100 Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4

Similar threads

Top Bottom