[PDF.38mh] Risk-based Management of GMP Audits: An Approach for a Medium-sized Pharmaceutical Company

Risk-based Management of GMP Audits: An Approach for a Medium-sized Pharmaceutical Company

[PDF.bi63] Risk-based Management of GMP Audits: An Approach for a Medium-sized Pharmaceutical Company

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 | #3336933 in eBooks |  2011-11-01 |  2011-11-01 | File type: PDF

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Within the European Union the manufacturing of medicinal products has undoubtedly reached a very high quality level. The principles of Good Manufacturing Practice (GMP) are required by law. A relevant part of the quality of finished products depends on the quality of the starting material, especially of the active pharmaceutical ingredients (APIs). In the framework of globalisation and due to the ever-increasing cost pressure APIs are meanwhile sourced in a worldwide mar...

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