Pharma IQ Glossary: 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.
Top 10 Medical Contract Manufacturing Organizations: 2018
February 27 by Pharma IQWe present the top 10 ranking of Contract Manufacturing Organizations in drug discovery as voted by the Pharma IQ network.
Multiparticulate Drug Delivery Systems
October 03 by T. E. Gopala Krishna MurthyMultiparticulates are the discrete, small, repetitive units of drug particles which may or may not possess similar drug release pattern.
In Demand: Prefilled Syringes
September 13 by Andrea CharlesThe 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...
