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Ruchika Raval, President, Global BioPharm Regulations

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Supplier and EU Pharmaceutical<br />

GMP<br />

• The source, origin and suitability of starting<br />

raw material should be clearly defined.<br />

• A system of master and working cell bank<br />

should be in place with appropriate seed lots,<br />

doubling time, consistency of cells<br />

FOR MORE INFO...<br />

Annex II EU - GMPS for Medicinal Products<br />

6/14/2009<br />

<strong>Ruchika</strong> <strong>Raval</strong> - <strong>Global</strong><br />

Biopharmaceutical Inc.<br />

6

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