Tag Archives: zero defects

Parenteral Packaging

Small volume parenteral packaging includes packaging sizes from 2 to 5 mL range and is most commonly included with local anesthetics, vaccines and other traditional injectables for patients.  Small volume parenterals are used with a luer lock or luer slip that can directly connect to syringes. 10 to 100 mL containers are typically used for…
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Routes of Drug Administration

The route of drug administration is defined as the path by which a drug is taken into the body.  Drugs are administered varied by diagnosis, prevention, cure or treatment needed of diseases and other medical disorders.  A drug must come in contact with the tissues of organs to achieve its desired effects. The route of…
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Removing Gaps in Data Integrity

Between January 2015 and May 2016 there was a total of 28 warning letters issued to pharmaceutical manufacturers. 21 of those letters were centered around issues involving data integrity.  If data is mutilated and changed, it does not promise that a product is safe, data integrity is extremely important to follow.  It is used to…
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Manual Visual Inspection is Still Critical

Automated visual inspection has been created to perform as an alternative to manual visual inspection.  This type of inspection is used to lower the cost and speed up the inspection process; pushing more drugs into the market.  In USP <1790> it explains that any inspection other than manual inspection has to be “equivalent or better…
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