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並前往https://ec.europa.eu/health/sites/default/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf

Annex 1 1 Manufacture of Sterile Medicinal Products 2 ...

Pharmaceutical Quality. System (PQS). Highlights the specific requirements of the PQS when applied to sterile medicinal products. 4. Personnel. Guidance on the ...

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