Biomedical Engineering Reference
In-Depth Information
Figure 6.25
(
Continued
)
•
name and strength/potency of the product;
•
specifi c batch number of the product;
•
date of manufacture and expiry date;
•
storage conditions required.
Additional information often presented includes the name of the manufacturer, a list of excipients
included and a brief summary of the correct mode of product usage.
When a batch of product is labelled and packed, and QC personnel are satisfi ed that labelling
and packing are completed to specifi cation, the QC manager will write and sign a 'Certifi cate of
Analysis'. This details the predefi ned product specifi cations and confi rms conformance of the
actual batch of product in question to these specifi cations. At this point, the product, along with its
Certifi cate of Analysis, may be shipped to the customer.
Further reading
Books
Ahmed, H. 2005.
Principles and Reactions of Protein Extraction, Purifi cation and Characterization
. CRC
Press.
Carpenter, J. 2002.
Rational Design of S
table
Protein Formulations
. Kluwer.
Costantino, H. and Pikal, M. (eds). 2005.
Lyophilization of Biopharmaceuticals
. AAPS Press.
Desai, M. 2000.
Downstream Protein Processing Methods
. Humana Press.
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