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. 2020 Jul 11;67:94–111. doi: 10.1016/j.biologicals.2020.06.002

Table 2.

Evolvement of European Pharmacopoeia to facilitate the use of NGS.

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    (Hum + Vet) Ph. Eur. Chapter 5.2.14. Substitution of in vivo method(s) by in vitro method(s) for the quality control of vaccines, version 9.3, July 2017, creation.

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    (Hum) Ph. Eur. Chapter 5.2.3. Cell Substrates for the production of vaccines for human use, version 9.0 and updated version 9.3, July 2017, revision.

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    (Hum) Ph. Eur. Chapter 2.6.16. Tests for extraneous agents in viral vaccines for human use”, version 9.3, July 2017, revision. Corrected version in Supplement 9.4.

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    (Vet) Ph. Eur. Chapter 5.2.4. Cell cultures for the production of vaccines for veterinary use,version 10.2, July 2020, revision.

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    (Vet) Ph. Eur. Chapter 5.2.5. Management of extraneous agents in immunological veterinary medicinal products, version 10.2, July 2020, revision.

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    (Vet) Ph. Eur. Chapter 2.6.37. Principles for the detection of extraneous viruses in immunological veterinary medicinal products using culture methods, version 10.2, July 2020, creation.