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In the manufacturing of sterile medicinal products, the maintenance of the sterile boundary is the most critical safeguard for patient safety.
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| Document type | Code |
|---|---|
| SOP | SOP-DP-001 |
| Form | FRM-DP-001 |
FDA 21 CFR 210/211 and Part 11, EU GMP (EudraLex Volume 4, including Annex 1 and Annex 11), ICH Q7–Q12, and WHO GMP. Supplied in 13 languages.
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