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Fill and Finish (Parenteral Drugs)

Fill and Finish (Parenteral Drugs) refers to preparation of parenteral drugs, either LVPs or SVPs, which demand the highest level of contamination control, because the human body's normal defenses against infection are bypassed when parenteral medications are introduced either intramuscularly (I.M.) or intravenously (I.V.) directly into the body. The processing of raw materials into finished dosage forms must comply at all times with cGMPs and must be able to support process validation. Mechanical design should include HVAC Classifications considered essential to attain global regulatory acceptance. For classifications, see the ISPE® Guide for Sterile Manufacturing Facilities. The desire for increased levels of sterility assurance has led the FDA to promote the use of terminal sterilization for aseptically filled products. The FDA has stated that terminal sterilization processing is the method of choice unless the manufacturer can show that it is detrimental to the product. Terminal sterilization may be accomplished using autoclaves that apply overpressure to balance the pressures that are developed across the inside and outside of the containers. Because of product sensitivities, biologics, and blood products are not appropriate applications for terminal sterilization.

The Process of Drug Development: Time to Market

The term Drug Development covers a wide range of activities, from clinical trials to the creation of new compounds, all of which help drive a particular product to market. In its entirety, the process can take more than a decade, and cost...

Contributor: Pharma IQ
11/09/2010 07:00:00 PM EST
T. E. Gopala Krishna Murthy

Multiparticulates or multiple unit dosage forms are the discrete, small, repetitive units of drug particles which may or may not possess similar drug release pattern.  They can be tailored for pulsatile, controlled and or delayed, targeted drug...

Contributor: T. E. Gopala Krishna Murthy
09/27/2010 08:00:00 PM EDT
In Demand: Prefilled Syringes

The prefilled syringes sector has witnessed healthy growth in recent years and demand is expected to rise. This is due to the increased number of injectable biological drugs in the pipeline and healthcare professionals and patients demanding...

Contributor: Andrea Charles
09/09/2010 08:00:00 PM EDT