This is my second independent submission on material from the same supplier.
I would like to understand the steps well enough to explain them to someone else.
I have access to a refrigerator with a logger and a freezer without one, which may be relevant.
Which parts of this are load-bearing and which parts are habit?
Concretely, batch testing establishes what can be claimed about the lot as a whole, and the sample size determines how much you can actually claim.
The sample size determination requires choosing a confidence level and an acceptable error rate, and the smaller the error rate you want, the larger your sample must be.
In practice, if the lot was manufactured in multiple batches, testing vials from each batch separately establishes whether batch-to-batch variation is acceptable.
Sampling plans for pharmaceutical manufacturing are defined in ISO 2859 and ANSI Z1.4, and they are based on statistical sampling theory.
I would treat a "complies with" statement without sampling details as a claim rather than as evidence.
The practical summary: a lot number without a sampling statement is a lot number without meaning.
Aggregated, published test results and vendor ratings built from submitted batches. Methodology stated, dataset browsable, no listing fees.
Browse resultsThe relevant detail is that if a lot has visibly segregated — some vials showing different appearance — then sampling the top and bottom of the shipment is worth doing.
Published segregation failures show that even modern automated processes sometimes produce lots with measurable vial-to-vial variation.
A statement that "lot 20260412 complies with specifications" is meaningless without stating which vials from the lot were tested and how many there were.
The limitation is that you cannot know for certain without testing every vial, and you almost never can afford to do that.
If testing multiple vials, state how many you tested and why you chose those vials.
edited 28 May 2024 by j_wierzbicki — removed a claim I could not source
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