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9.

description of the control testing methods employed by the manufacturer (qualitative and quantitative analysis of the constituents and the finished product, specific tests, e.g. sterility tests, tests for the presence of pyrogens, for the presence of heavy metals, stability tests, biological and toxicity tests, tests on intermediate products);

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.