Receiving Raw Materials, Inspection, Release

[chimie]

Hello,
We are a biotech start-up with no current method for receiving, inspecting and releasing incoming raw materials. I need to write an SOP for this and have been searching the site for awhile but haven't found the info that I'm looking for. I am looking for a detailed, but simple procedure beginning with how raw materials are checked in, assigned a receiving number, sampled for inspection, placed in quarantine, released and then stored for future production use. We want to keep it simple but still meet the basic requirements for inspection of raw materials for use in finished product. The following are some of the questions I have.

1) I assume all incoming raw materials/chemicals have to be tested against our specification, or can we just compare supplier CofA to our spec without testing the material?

2) How is sampling done for chemicals to be tested? How do we determine where to draw the sample and how many samples to test?

3) How is non conforming material handled? Can we just affix a Reject label, fill out a non conforming form and send it back to the supplier for a refund or exchange?

Thanks!

 

[v9991]

Most relevant and elaborate examples can be adopted from following reference...
http: // www. fda. gov/ScienceResearch/FieldScience/LaboratoryManual/ucm171610.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
also pick up respective points from following checklist...
Pharmaceutical Quality Control Labs (7/93)

also, have a look at pg.359 of the following reference...
(broken link removed)

to ans your specific queries...
...analysis vs comparison with COA...
1) you CANNOT completely rely on vendor's COAs., all the critical ingredients to be tested completely to ensure compliance to specification. You need to identify specific/critical parameters which need to be verified/ensured at your end.
exceptionally, wavier can be done for certain parameters which are 'pre-validated/qualified' at vendor's site...

...sampling...
2) typically, all containers need to be sampled for analysis; complete analysis is performed on pooled sample; however, you must determine test parameters which are relevant& required to analyze those specific samples;

...handling rejects...
3) YES...but before doing that, you must establish through proper investigation to establish proper root cause(mostly excluding the possibilities of IH analysis, sampling, method, etc., as cause)...

hope this helps...

 

[Ninja]

Howdy chimie,
Some thoughts,

We are a biotech start-up ...

I am not in that industry...please take my comments and apply on top of them any industry specific requirements.

1) I assume all incoming raw materials/chemicals have to be tested against our specification, or can we just compare supplier CofA to our spec without testing the material?

That depends on what you have determined are the NEEDS of the material. Often, folks will move to just accepting CoA only after confidence is established with the supplier's quality system.
No confidence = test it yourself.
Confidence + critical parameter = test it yourself
Confidence + low level of need (maybe)=(maybe) accept the CoA data.

2) How is sampling done for chemicals to be tested? How do we determine where to draw the sample and how many samples to test?

There are many techniques for random sampling...you may also want to contact the vendor of the material to see how they sample. It may give you some insight into what you might do.

3) How is non conforming material handled? Can we just affix a Reject label, fill out a non conforming form and send it back to the supplier for a refund or exchange?

This sounds good...but you'll want to verify it with the supplier as well. How you handle reject material will be based somewhat on the purchase terms of the material from the vendor. It really doesn't matter how this is handled as long as certain criteria is met:
- The material is quarantined to protect it from use in your process.
- The material is labeled as out of spec.
- There is a record that the material was unacceptable as received.
- There is a record of WHY the material is considered unacceptable.
- There is a record of how the material was dispositioned.

 

[NikkiQSM]

1) I assume all incoming raw materials/chemicals have to be tested against our specification, or can we just compare supplier CofA to our spec without testing the material?

2) How is sampling done for chemicals to be tested? How do we determine where to draw the sample and how many samples to test?

3) How is non conforming material handled? Can we just affix a Reject label, fill out a non conforming form and send it back to the supplier for a refund or exchange?

I am in the medical plastics industry - so I am not familiar with the testing of chemicals... But here is what I can offer..

#1. You should check materials - do not completely put all of your trust into your supplier. We conduct quality tests on materials and compare the results to the manufacturer's COA, and to the requirements of the product we are going to make with it. We also compare the supplier's COA to previously received COAs to ensure that the supplier has not changed their own specifications without informing us.

#2. As I mentioned before, I am not familiar with testing chemicals. Sampling amounts can rely on what the material is, the impact it has on the "final product", and how much of it you have. With plastics - we base our sampling amounts on the quality testing history for that product. If it's a resin that usually is not very consistent, we test each container. We use a staffing wand, (long brass rod with holes down the entire length), this way when opened after being placed into the container, it gets a sample of the product at all levels.

#3. If product is rejected, you will identify it as such with a rejection label of some sort. Record the issue, what is wrong with it, why you can't use it, and what you are / did do with it. I would also complete a supplier corrective action and send it to your supplier with or without the returned rejected product. Require that they complete the document and explain why the issue happened and how it will not happen in the future.

 

[chimie]

Thank you all your replies and links.


Does anyone have a good numbering system for all incoming raw materials (receiving number) that would also describe the disposition of the lot (released, quarantine)?


When the material is issued out for production, how is it normally tracked? A log with starting quantity, date, quantity removed and quantity remaining? Production batch issued to?

Top Kwality, do you pool the samples from each container or test each sample from each container?

Thanks!

 

[ssz102]

though i have no much experience for this field, i have some suggestions as below:
first, beacause your product is belong to chemicals, you requires supplier provide CoC and MSDS to you and know them composition
the way of sampling can be taking one barrel or bottle as per lots, if you find NG, the NG are isolated first, and then issue VCAR to supplier require them improvement
for the numbering system, you can design a material colding principle, and after product are tested, you paste the label to trace

 

[v9991]

Thank you all your replies and links.


Does anyone have a good numbering system for all incoming raw materials (receiving number) that would also describe the disposition of the lot (released, quarantine)?


When the material is issued out for production, how is it normally tracked? A log with starting quantity, date, quantity removed and quantity remaining? Production batch issued to?

Top Kwality, do you pool the samples from each container or test each sample from each container?

Thanks!

1)
usually two distinct numbers, 1) goods receipt note 2) number assigned by Quality control
we usually have numbering system which indicate,
'material category' raw, pack, water, miscellaneous etc
'year'...some component of year either last 2 or 4 characters...
'sequential number' assigned starting with '0' at beginning of year,.

it is not usual practice to track the goods disposal through above numbers (its more practical to have labels of red-yellow-green affixed based on the QC-analysis outcome; + more of a procedural control that without green label, goods cannot be dispensed!!! );
but you can always assign the suffix (Approval / rejection) in your case.

2)
its called bin card system...
for each material and 'batch/lot' separate bin cards are created....and arranged in a suitable FIFO (first in first out)/ FEFO(first expiry first out) order...
goods dispensing is determined in the above order and they are simply updated after completion of dispensing.

hope that it helps.

 

[chimie]

v9991,

Thank you for being so helpful. In your previous post, you mentioned that samples are pooled and then tested. Is this how it is normally done? So, each container is not tested individually? All samples from all containers are pooled together? What is used to take the samples? Something sterile to prevent contamination? One other post mentioned staffing wand? Any other devices used?

Btw, I noticed in the upper right hand corner of each post, there is a tally of thank yous. How do I thank you formally for your posts?

Thanks!

 

[v9991]

1) pooled sample...what i had mentioned is that...
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.

2) regarding...maintaining the samples intactness..sterility etc.,...
Yes, this is very critical part...you wouldnt want to contaminate the material...
this has to do with the preparation-handling-cleaning of sampling aids...
viz., cleaning validation of sampling tools, etc.,

3) sampling tools...
https://apps.who.int/prequal/info_general/documents/TRS929/WHO_TRS_929-Annex4.pdf

4) acknowledgements thanks...karma etc
simply, you will find "thanks" button at the end of each post...simply click on it...it will add on to the posts count...
further gyan at...discussions related to the subject...
https://elsmar.com/Forums/showthread.php?t=22139&highlight=karma%2C
https://elsmar.com/Forums/showthread.php?t=53119&highlight=karma,