Extension of a stability study for an API

#1
Dear all,

Firstly I would like to thank you for this fantastic forum.

I was wondering if any of you has any experience with extension of a stability study (for an API).
The norm for ICH is to test up to 5years, which means that protocols for these studies foresee enough samples to be stored (under suitable conditions) for 5 years.
However, if for some reason a manufacturer decides to extend this study after 5 years there would be of course no samples left to perform testing.
My question is: Is there a way to incorporate this description in a protocol, so that enough sample can be stored to be tested after 5 years and avoid deviating from the protocol?

I am looking forward to your answers.
 
Elsmar Forum Sponsor

Statistical Steven

Statistician
Staff member
Super Moderator
#2
Dear all,

Firstly I would like to thank you for this fantastic forum.

I was wondering if any of you has any experience with extension of a stability study (for an API).
The norm for ICH is to test up to 5years, which means that protocols for these studies foresee enough samples to be stored (under suitable conditions) for 5 years.
However, if for some reason a manufacturer decides to extend this study after 5 years there would be of course no samples left to perform testing.
My question is: Is there a way to incorporate this description in a protocol, so that enough sample can be stored to be tested after 5 years and avoid deviating from the protocol?

I am looking forward to your answers.
You can store material for 10 years if you choose. The ICH Q1 guidance is just a suggestion. The question is why would you want to extend your stability passed 5 years? You can always write a protocol that does yearly or bi-annual pulls from year 5-10 for example.
 
#3
I think that would be the best thing to do.
Although it might sound strange this is more of a resources/logistic brainstorming question.
For example for the stability of product A, there are X samples prepared for up to Z years but while the study is on-going a decision is taken to extend it to more than Z years. It is sensible to ask why would you extend the study - but let's leave that to the side for now.
So where do I find the extra samples? ..
The only reasonable answer I can think of is to foresee extra material in the protocol "just in case"..
Is this just enough or are there other ways? Does anyone ever had any similar issue?
 
Thread starter Similar threads Forum Replies Date
J Documenting a Calibration Interval Extension Calibration Frequency (Interval) 7
J Remote location vs. site extension IATF 16949 - Automotive Quality Systems Standard 3
R Extension of product nonconformances - Construction project Nonconformance and Corrective Action 7
R Documenting Expiration Date Extension for a specific lot ISO 13485:2016 - Medical Device Quality Management Systems 12
M FDA News USFDA Proposes to End Temporary Extension of GUDID’s Grace Period Medical Device and FDA Regulations and Standards News 3
J ISO 13485 Recertification audit extension ISO 13485:2016 - Medical Device Quality Management Systems 1
B Site Extension across the street to expand IATF 16949 - Automotive Quality Systems Standard 4
I Device Shelf Life Extension to 48 months without involving the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Is ISO/TS16949 Extension Available? IATF 16949 - Automotive Quality Systems Standard 3
D Ethylene Oxide Sterile Implantable Medical Device Shelf Life Extension Other Medical Device Related Standards 1
M TS 16949 Site Extension Elimination? IATF 16949 - Automotive Quality Systems Standard 7
M Again ... about this IATF site extension rule... IATF 16949 - Automotive Quality Systems Standard 3
M Is a separate ISO/TS16949 certificate required for an extension site? IATF 16949 - Automotive Quality Systems Standard 4
M Has anyone successfully challenged the new IATF site extension change? IATF 16949 - Automotive Quality Systems Standard 36
P Scope Extension Audit - How many days? Do I audit all AS9100 requirements? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
D Torque Wrench Calibration Interval Extension with Non-Use? General Measurement Device and Calibration Topics 1
P TS 16949 Site Extension Elimination IATF 16949 - Automotive Quality Systems Standard 11
E Is Shelf Life extension a substantial change? EU Medical Device Regulations 6
WEAVER Thermocouple Extension Wire for Temperature Measurement in an Oven General Measurement Device and Calibration Topics 9
P Extension of Certification Scope Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Input and Verification of a Line Extension Design and Development of Products and Processes 3
K Calibration Procedure for ID Micrometer Calibration & Extension Rods General Measurement Device and Calibration Topics 5
J CE Marking Extension Cables for Class III EP Catheters EU Medical Device Regulations 6
J What is Manufacturing Extension? Audit Man-Days General Auditing Discussions 6
S Customers an Extension of the Sales Force? Customer Specific Marketing Material Quality Manager and Management Related Issues 3
D Shelf Life Extension - How to ReLabel Boxes? EU Medical Device Regulations 21
M Requesting an Extension for Surveillance Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J IAQG Resolution #67 - Extension of time frame for upgrade to ISO 9001:2008 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
A IATF Rules which define an "Extension Site" under TS16949 IATF 16949 - Automotive Quality Systems Standard 4
J Deadline Extension? New Excuse? Computer Enhancers for everyone Funny Stuff - Jokes and Humour 0
E How long does it take to certify a scope extension? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B AS9100 Initial Exposure - Completed my first AS9100 Scope Extension audit AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
S Does an ECG extension cable need a 510k? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Extension of Measurement Device Calibration Due Date. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 12
E Extension of Scope and Extension of Quality System - Differences General Measurement Device and Calibration Topics 1
G Have the OEMs issued an extension to suppliers if not TS registered? IATF 16949 - Automotive Quality Systems Standard 2
E Extension of Scope in terms of Laboratory Facilities General Measurement Device and Calibration Topics 2
C Having an Extension audit for the purpose of getting the CE-mark for our product ISO 13485:2016 - Medical Device Quality Management Systems 1
T Accredited Laboratory - Date Extension General Measurement Device and Calibration Topics 5
D Guide 25 Extension, IASG Interpretations General Measurement Device and Calibration Topics 0
G Accelerated stability of medical devices Other Medical Device Related Standards 1
R Revalidation machine line and Stability Studies impact. Medical Device and FDA Regulations and Standards News 3
S Stability accelerated vs. real-time Other Medical Device Related Standards 3
S Standards for real time stability for medical devices Other Medical Device Related Standards 2
C Medical Device Stability Studies - Non-validated pilot production Other Medical Device Related Standards 1
B Stability testing of medical devices as per ASTM F1980-16 CE Marking (Conformité Européene) / CB Scheme 0
lilybef Number of lots required for stability testing of a Class II device in the 510(k) Qualification and Validation (including 21 CFR Part 11) 3
V System suitability or stability during continuous usage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
O New stability - Yes or No - Similar product but for different intended use EU Medical Device Regulations 1
A Accelerated Stability Studies - Class III Medical Gloves Other Medical Device and Orthopedic Related Topics 1
Similar threads


















































Top Bottom