ABSTRACT
The inspection of parenteral products is driven by the need to minimize the introduction of unintended particulate matter to patients during the administration of injectable medications. Visual inspection also allows the opportunity to detect and reject other categories of nonconforming units, such as those with cracks and or incomplete seals that can affect the integrity and sterility of the product. The purpose of a visual inspection program is to satisfy the regulatory agencies and ensure the safety and quality of the drug product. A survey was presented at a Parenteral Drug Association forum in 2008 describing regulatory observations that had been reported over the last 12 years. Fifty percent of the firms surveyed were challenged on their inspection programs. An area of increasing attention and awareness is inspection of combination products and ensuring compliance to predetermined acceptance criteria. The requirements for particulate matter and inspection practices described will also apply to combination products.
