How Many Samples to send for Chemistry Testing

Hi all!

I'm hoping to get some answers. We manufacture a combo device with an API. We repackage the API into single unit dose (in powder form). Of course we have to perform release testing of our product. Release testing is in two realms - 1 being pouch testing, and the other being chemistry testing of the API.

For pouch testing, we have statistical sampling plan for attribute data and variable data.

For chemistry testing, we do not have a statistical sampling plan. The API is very expensive and want to provide the least amount of material possible for the batch.
For example, we are sending out 10 pouches for Micro, 2 pouches for ID/Assay, and 14 pouches for Completeness of Solution, all pulled randomly from the batch.

Do you think there will be an issue with this?? Please keep in mind we do not manufacture the API, we are simply repackaging.
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Ronen E

Problem Solver
I don't understand why you need to test the API routinely.
1. Don't you get some CoA from the supplier/manufacturer?
2. Why isn't it enough to test once per batch received?

Is the API sensitive to your process / environmental conditions etc.?
I don't understand why you need to test the API routinely.
1. Don't you get some CoA from the supplier/manufacturer?
2. Why isn't it enough to test once per batch received?

Is the API sensitive to your process / environmental conditions etc.?
Hi Ronen E,

I guess I am just assuming (per CFR 211 - release testing) that we need to perform release testing. The API mfg does give a CoA providing all the USP Monograph requirements. The API isn't sensitive to the process. It is repackaged in a clean room into single unit doses and assembled in a medical device kit. Is it not common to perform additional testing after repackaging?
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Ronen E

Problem Solver
If you are concerned you can validate the repackaging process. Sounds like the risk evaluation would conclude that the risk is low / acceptable - is there a formal one documented?

During process validation you might decide to implement a sampling & testing plan as a process control, but from what you are saying that would probably end up being of a limited scale (maybe very limited).

§211.165 Testing and release for distribution.
(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on specific batches of shortlived radiopharmaceuticals, such batches may be released prior to completion of sterility and/or pyrogen testing, provided such testing is completed as soon as possible.

(b) There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms.

(c) Any sampling and testing plans shall be described in written procedures that shall include the method of sampling and the number of units per batch to be tested; such written procedure shall be followed.

(d) Acceptance criteria for the sampling and testing conducted by the quality control unit shall be adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection levels.

(e) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with §211.194(a)(2).

(f) Drug products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed. Prior to acceptance and use, reprocessed material must meet appropriate standards, specifications, and any other relevant criteria.
I don't see why a formal, thorough documented justification shouldn't work for showing compliance with the above. Maybe use that as guidance for closing any apparent gaps in your documentation trail (e.g. documentation received from your supplier).
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