Sampling Plan and Procedure wanted - Chemical Trading Company

N

no_angel - 2011

#1
Can someone help me or give me tips on how to create a sampling plan? we are a chemical trading company and our main function is the warehousing of materials prior to delivery of materials to client. one of our client is requiring us to submit a sampling procedure that states how we conduct our inspection for received materials from our principal and the rejection process based on the materials received. thanks! will appreciate any help that you can extend.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
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#2
Re: Sampling Plan and Procedure wanted

Anyone able to help with this one? My Thanks in advance.
 

v9991

Trusted Information Resource
#4
You will definitely require an procedural/material control for receiving-confirmation-dispatch (traceability of correct & right materials)
though the extent & depth of activities could wary...

receiving... indent/purchase order vs dispatch/delivery note vs material Label vs quantities.
confirmation... above details vs certificate of analysis ; storage conditions, handling precautions etc.,
dispatch - once again purchase order vs delivery challan etc.,

being a warehousing & trading company...Am not really sure about sampling plan and its intent ; I guess, one simple statement to provide is that each the containers/material are verified to have right labels...etc.,
 
Last edited:
C

chimie

#5
Hello,

Please help.....I'm still really stuck on this one. We are a startup drug co. and I need to write a procedure on a sampling plan for raw materials (liquid and powders) that we receive and need to test prior to release. So far I have found this table below but it doesn't seem to make sense to me yet.

Lot size is no. of containers? So, if I have 5 containers of a lot of material, does the sample size mean the number of samples I need to take from those 5 containers? So, in this case, 2? Shouldn't I be testing all 5 containers? How do I know which container to take a sample from?

I have seen info on various types of sampling like stratified random, but the explanations are vague.

What is the best sampling plan for raw materials? Should I even be using AQLs?

Thanks!

LOT SIZE 2 to 8
SAMPLE SIZE 2
AQL = 1.0
ACC 0
REJ 1



 
Last edited by a moderator:

v9991

Trusted Information Resource
#6
For a drug substance/product company,
ITs some time since the sampling procedures stopped using AQL concepts. as i had earlier described in another post...page.2 Receiving Raw Materials, Inspection, Release

supposing there are 10 tests for analysis of material...pooled sample is used to analyze all the tests and
you have to identify 1 or 2 tests which are related to identity of material and use it to analyze the samples of individual containers.
so in your example, case if you hae received 5 containers, you ought to sample all of them individually, use those individual samples for testing some specific/critical tests such as identification etc., ; and pool those samples and use that for testing rest of the paramters.

However, AQL concept of sampling and assessment is still used in packaging material analysis..
in the example you have quoted, if its applied for Packing materials, its interpretation is as follows...
you have received 5 boxes of packing materials (each one carrying 100 units of PM)

Now, you need to randomly pick up 2 boxes; and again pick up 13 samples randomly, (30-100 units --> sampling qty is 13 or 18 i don't exactly recollect)

and analyze for defects/quality attributes; YOu need to reject if you find 1 of them to be defective as per AQL.
(now this Rej=1, also depends on the AQL criteria to be selected ...)
 
Last edited:
C

chimie

#7
OK. Thank you for clarifying v9991....very helpful!

I guess I am confused too as to how many samples from each container I should be taking. Is one from each container suffice if we assume that the material is homogeneous/uniform? Or, do I need to take multiple samples from each container in different areas of the container?

Thanks!
 

v9991

Trusted Information Resource
#8
I guess I am confused too as to how many samples from each container I should be taking.

Is one from each container suffice if we assume that the material is homogeneous/uniform?

Or, do I need to take multiple samples from each container in different areas of the container?

Thanks!
you cannot always assume the uniformity/homogeneity of materials...
for solids, sampling tools are designed such that samples are collected from all the levels(top to bottom) of containers.
even for solvents...wherein you need to collect samples from top-botton portions...

this is exactly what is demonstrated in the WHO reference....where different types of sampling tools are described (with photographs...Ref Appendix 1)...
http://apps.who.int/prequal/info_general/documents/TRS929/WHO_TRS_929-Annex4.pdf

Receiving Raw Materials, Inspection, Release - Page 1
Receiving Raw Materials, Inspection, Release - Page 2

hope this helps...
 

raghu_1968

Involved In Discussions
#9
Hello,

Please help.....I'm still really stuck on this one. We are a startup drug co. and I need to write a procedure on a sampling plan for raw materials (liquid and powders) that we receive and need to test prior to release. So far I have found this table below but it doesn't seem to make sense to me yet.

Lot size is no. of containers? So, if I have 5 containers of a lot of material, does the sample size mean the number of samples I need to take from those 5 containers? So, in this case, 2? Shouldn't I be testing all 5 containers? How do I know which container to take a sample from?

I have seen info on various types of sampling like stratified random, but the explanations are vague.

What is the best sampling plan for raw materials? Should I even be using AQLs?

Thanks!

LOT SIZE 2 to 8
SAMPLE SIZE 2
AQL = 1.0
ACC 0
REJ 1



The normal industrial practice of sampling plan which is followed in the bulk drugs are as follows:

1. If the number of container is less than 5, then all the containers have to be sampled.
2. If the number of container is more than 5, the following formula have to be applied:

Square root(N) + 1, Where N = Number of containers.

Hope this will help.
 
C

chimie

#10
OK. Thank you. Now in the case of square root(N) +1 which equals the number of containers to sample, what method do I use to determine how many samples from each container?
 
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