Sampling Plan for Destructive Testing

v9991

Trusted Information Resource
#1
background :-
in
pharmaceutical drug products, most of the testing involves destructive testing,
some tests have quantitative results;
using single-units to report single values.
others using multiple units to report single value.

further
some tests have qualitative(attribute) results, mostly as pass/fail with only one criteria.
again some tests use single units and others use multiple units

Question :-
A) when a sample size is determined, lets say n=100, (with c=0)
  • does it mean that each test characteristic to be analysed on 100 samples. (i.e., if there are 10 tests, then sample size =1000)
OR
  • can 100 be distributed among 10 tests with respective way (viz., one test might require 1 sample, another 20, another 10 etc)

request clarifications on interpretation of data.


references :-
reference on US FDA citing for a statistical basis for qualitative tests1
"Furthermore, revise your sampling plans to ensure they are statistically appropriate and non-uniform contamination can be detected. The revisions should encompass finished API testing, in-process testing, and raw material acceptance testing."
another reference...
For example, your firm's finished product sampling plan for (b)(4) and (b)(4) in Propofol Injectable Emulsion is not representative of the batch produced. A total of thirteen units are sampled per lot, with three tested for bacterial endotoxin and ten tested for bioburden. This sampling of thirteen units is irrespective of lot size, which may vary from (b)(4) to (b)(4) units (vials) per lot.


Your response, dated August 10, 2009, is inadequate. You do not reference a sampling plan that utilizes basic elements of statistical analysis or provide a scientific rationale for sampling that would vary the amount of samples taken according to the lot size. Your response does not define a confidence limit to ensure an accurate and representative sampling of the product.
there are similar expectations are outlined for the quantitative tests as well.
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Staff member
Super Moderator
#2
The sample size that is statistically valid applies to individual characteristics. So if a unit can only be tested for 1 characteristic then yes you would need 1000 samples to get 100 units for each of the 10 characteristics. OR have a scientific rationale for a different size.

The key here is use of the term non-uniform. The downside of all acceptance sampling is the assumption of a random sample and a mostly homogenous - or uniform - distribution of the defect. Contamination is often NOT uniformly distributed and small samples even if taken randomly are inadequate to catch the contamination. Your sample plan would have to directed at time points when contamination might occur (this is the scientific part of your sampling plan).
 

v9991

Trusted Information Resource
#3
Thank you Bev D;:thanks: just want to reconfirm and make sure that i represented my question completely.
So if a unit can only be tested for 1 characteristic then yes you would need 1000 samples to get 100 units for each of the 10 characteristics. OR have a scientific rationale for a different size.
1) if a test requires viz., 10 samples for single determination (destructive testing), then should we take 1000 samples for that test alone?


The key here is use of the term non-uniform. The downside of all acceptance sampling is the assumption of a random sample and a mostly homogenous - or uniform - distribution of the defect. Contamination is often NOT uniformly distributed and small samples even if taken randomly are inadequate to catch the contamination. Your sample plan would have to directed at time points when contamination might occur (this is the scientific part of your sampling plan).
i agree; this is just a thought i would like to share with you, FDA seems to be thinking of "statistical relevance" (ref. above citations quoted in first post)
 
Thread starter Similar threads Forum Replies Date
C Sampling plan for destructive tests on small lots ISO 13485:2016 - Medical Device Quality Management Systems 20
M Manufacturing Process Validation Destructive Testing Sampling Plan Advice Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
A Destructive Testing Failure Mode Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
A Sampling plan for destructive test Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
E Sampling Plan for Destructive Testing - Personal Body Armor Plates Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
R Reduced sampling plan for sterial products APQP and PPAP 0
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 1
B AS9100D Sampling Plan AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Nicole Desouza Sampling plan for a customer who wants AQL 1.0 (per ANSI Z1.4) AQL - Acceptable Quality Level 5
M Sampling Plan for Alumin High Pressure Die Castings Manufacturing and Related Processes 0
E Sampling plan for orthopedic implant - Process Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
S How to make a Sampling Plan - Conveyor belts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
S Help develop sampling plan for prototype samples (medical devices) Statistical Analysis Tools, Techniques and SPC 7
M Zero Defect Sampling Plan Standards Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
L ISO 2859-2 LQL sampling plan linked to %confidence/%reliability Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K Sampling Plan for transparent tubular plastic parts from 32 different cavities Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A AQL Sampling Plan SOP / WI - Medical Device Industry Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
J Sampling Plan Questions from the CQE Practice Exam Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Sampling Plan for for Chemical Analysis Testing of Medical Devices EU Medical Device Regulations 3
J Can ANSI Z1.4 sampling plan be used for sampling alone without the Acc/Rej criteria? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
B Designing a Sampling Plan - AQL AQL - Acceptable Quality Level 19
N Use of arrows in ISO 2859-1 Table 1 and 2-A sampling plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S AS9100 Sampling Plan Requirements - 8.2.4 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Military Sampling Plan 105E vs. ISO 2859-1 AQL - Acceptable Quality Level 2
kedarg6500 Acceptance Sampling Plan for Variables - Product Performance Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
S Where could I get reference to an OQA Sampling Plan of 1 per 1000 ? Quality Manager and Management Related Issues 4
R What to Report when Using C=0 Sampling Plan Supplier Quality Assurance and other Supplier Issues 15
R Results: Monte Carlo Simulation of Acceptance Sampling Plan AQL - Acceptable Quality Level 3
G Sampling Plan according to SAE ARP9013 C=0 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
G Sampling Plan for Inspection of Metal Parts after CNC Machining Inspection, Prints (Drawings), Testing, Sampling and Related Topics 34
S Class III Sampling Plan - Explain AQL vs. 95%C & 90%R Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
G Sampling Plan for a Performance Qualification of an Inflation System Qualification and Validation (including 21 CFR Part 11) 2
S How to establish a Sampling Plan from the Rework percentage? AQL - Acceptable Quality Level 6
Q Sampling Plan for Paper and Tape Industry Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
C Medical Device Tracking Sampling Plan using MIL-STD-105E Other US Medical Device Regulations 4
P Lot Acceptance Plan that specifies BS 6001 Double Sampling Plans, general inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
B Best Attribute Data Sampling Plan - Early Production Containment Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
B In-Process Sampling Plan for a Secondary Package Adjustment Process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Proud Liberal Making a simple Sampling Plan by Variables Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
E How to determine the Lot Size for the OQ Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
L Electrical Cable Harness Quality Control - Sampling Plan for Pull Test Manufacturing and Related Processes 4
G Sampling Plan - Sample Size Justification for a Bottling Cleaning Process Validation Qualification and Validation (including 21 CFR Part 11) 2
I Alpha and Beta in the Sampling Plan for ISO 2859 & ISO 3951 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
V Sampling Plan for Final Inspection and Process Verification Inspection, Prints (Drawings), Testing, Sampling and Related Topics 21
M Sampling Inspection at QA - Inputs on the following sampling plan Statistical Analysis Tools, Techniques and SPC 3
D Does Sampling Plan Revision need Customer Approval? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K Sampling Plan for Small Lots of Single Use Items Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8

Similar threads

Top Bottom