Lyophilization Regulatory Center

Compliance Hub — FDA, EU GMP Annex 1, WHO & ISPE

Browse FDA 21 CFR Part 211, EU GMP Annex 1, WHO, and ISPE regulatory documents. Side-by-side multilingual translations with expert-verified corrections.

Regulatory Bodies

Terminology Glossary(83)

Good Manufacturing Practice (GMP)

Current Good Manufacturing Practice (cGMP)

21 CFR Part 11

21 CFR Part 210

21 CFR Part 211

ICH Q7

ICH Q9

ICH Q10

Installation Qualification (IQ)

Operational Qualification (OQ)

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FDA Regulations

21 CFR Part 21114 sectionsPublished: 2024-01-15Updated: 2025-11-20

Current Good Manufacturing Practice for Finished Pharmaceuticals

Translations: ZH, DE, FR

Available 1 comments

FDA Guidance8 sectionsPublished: 2023-06-01Updated: 2025-09-15

Lyophilization of Parenteral Drug Products — Process Validation

Translations: ZH, DE

Available

Translation Preview — EU Annex 1, Section 8.1

Original (English)

8.1 The design qualification of a freeze dryer should include leak rate testing of the chamber to demonstrate that the equipment is capable of maintaining the required vacuum level during the lyophilization process. The maximum allowable leak rate should be defined based on the process requirements.

Translation (中文)AI v1

8.1 冻干机的设计确认应包括腔室泄漏率测试，以证明设备能够在冻干过程中维持所需的真空水平。最大允许泄漏率应根据工艺要求确定。