EMA/CHMP/BWP/187338/ 2014: Guideline On Process Validation For The Manufacture Of Biotechnology-Derive D Active Substances And Dat.pdf

guideline-process-validation-manufacture-biotechnology-derived-active-substances-data-be-provided_en.pdf
Preview of EMA/CHMP/BWP/187338/ 2014: Guideline on Process Validation for the Manufacture of Biotechnology-Derive d Active Substances and Dat
🔗 Source: ema.europa.eu
📊 Size: 181 KB
👤 Author: European Medicines Agency
⬇️ Downloads: 89

Summary

The European Medicines Agency (EMA) issued a guideline on process validation for biotechnology-derived active substances, covering process characterisation and verification. The guideline applies to the manufacture of medicinal products and addresses data requirements for regulatory submissions. Process characterisation involves process development and evaluation to design a commercial manufacturing process, while process verification confirms the process performs effectively in routine manufacture. The guideline adopts a lifecycle approach, linking product and process development, validation, and maintenance of the process during commercial production.

Description

The European Medicines Agency (EMA) issued a guideline on process validation for biotechnology-derived active substances, covering process characterisation and...

Technical Information

  • File Format: PDF
  • File Size: 181 KB
  • Pages: 13
  • Language: EN
  • Author: European Medicines Agency
  • Total Downloads: 89
  • Last Updated: 1 month ago

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