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MID-ATLANTIC REGIONAL INSPECTION GUIDE FOR THE

LYOPHILIZATION OF PARENTERALS

 

There are many new parenteral products, including anti-infectives, biotechnology derived products, and in-vitro diagnostics which are manufactured as lyophilized products.  Additionally, inspections have disclosed potency, sterility and stability problems associated with the manufacture and control of lyophilized products.  In order to provide guidance and information to investigators, some industry procedures and deficiencies associated with lyophilized products are identified in this Inspection Guide.

 

 

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