Details

Autor(en) / Beteiligte

• Teasdale, Andrew
• Chéry, Cyrille C
• Cook, Graham
• Glennon, John
• Harris, Laurence
• Lee, Carlos W
• Lewen, Nancy
• Nethercote, Phil
• Powell, Samuel
• Rockstroh, Helmut
• Rutter, Laura
• Smallshaw, Lance
• Thompson, Sarah
• Woodward, Vicki
• Ulman, Katherine

Titel

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Ist Teil von

• Pharmaceutical technology Europe, 2015-03, Vol.27 (3), p.12

Ort / Verlag

Monmouth Junction: MultiMedia Healthcare Inc

Erscheinungsjahr

2015

Link zum Volltext

Quelle

EBSCOhost Business Source Ultimate

Beschreibungen/Notizen

• The second aspect of any risk assessment of the CCS involves an understanding of the potential levels of metals present within the material concerned. A major review of materials in manufacturing and packaging systems as sources of elemental impurities in packaged drug products was published in 2013 (7).