3.

A quality control plan must be drawn up in writing and implemented, to include, in particular, checks on the critical points in the manufacturing process, sampling procedures and frequencies, methods of analysis and their frequency, compliance with the specifications – and the destination in the event of non-compliance – from processed materials to final products.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-09 · Text as adopted (Official Journal); later amendments are not incorporated in this text.