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swine flu/ pharmaceutical

After the outbreak of swine flu, out of concerns about the economic situation further, global investors have started to panic and out of the hands of the stock, which also makes the global capital markets generally fell.
However, global investors worried about the same time, a unique industry in this crisis is likely to gain excess profits, and that is the pharmaceutical industry. As a result of the control and treatment of disease requires large amounts of vaccines and drugs, the pharmaceutical industry will no doubt profit is the thing. Roche flu drug production company has already begun active preparations for the WHO to provide drugs?

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Intrinsic features of Medicinal Products

What are the differences between GMP guides for
APIs and for MPs?

Batch review and release of
the finished product
APIs:
QU (specified authorised persons)(2.14, 2.22.1)
MPs:QC and the authorised person
(1.2, 1.4, 2.3,6.3, ref to MA)

-Internal audit / self inspection:
Independence, defined scope,
competent people
APIs: -(2.4)
MPs:  +-(Chap. 9)

Annual product Quality
Review (supports the decision
for the need for validation)
:
APIs: +(2.5)
MPs:+(1.5)


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Intrinsic features of APIs

Intrinsic features of APIs:
• Synthesis, fermentation, extraction, purification,
crystallisation…
• closed system located outside
• by-products
• Use for M.P. Manufacturing
• control depends on process and manufacturing
stage – IPC – impurity profile
• validation of critical processing steps
• potable water/purified water/WFI
• reprocessing: typical
• batch records for critical process steps
reviewed by the QC unit
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