Investigation of manufacturing defects and cGMP lessons learnt from quality issues in Pharmaceutical Sterile Preparations

Abstract

Any medicinal product introduced in the market ought to have the highest safety, quality, purity and efficacy as it is received by an ailing patient. Parenteral products are sterile pharmaceutical preparations that are injected, infused or implanted in the body. These products must maintain their quality and sterility as they are introduced directly into the bloodstream. Negligence associated with parenteral preparations can lead to severe or fatal adverse events. Although each country has its own regulatory body to keep a check on medication errors, defects keep occurring in pharmaceutical products. It should be the top priority of pharmaceutical companies to avoid these defects and related issues. This study focuses on three such real life defective parenteral products obtained from the hospital pharmacy. The probable root cause, remediation and clinical significance of the noted defect is also mentioned. These case studies can help pharmaceutical manufacturers minimize defects, quality issues to avoid product recalls and to achieve better therapeutic compliance.

Comparing visual inspection methods for parenteral products in hospital pharmacy: between reliability, cost, and operator formation considerations

“…In order to eliminate the artefacts from glass surface, an image analysis was performed on empty vials. 20 The detection limit was settled to 100 µm, except for vials containing fibres in which the limit of detection was increased to 1 mm.…”