After a recent spate of inspections, conducted by the Food & Drug Association (FDA), it seems quality control (QC) procedures are being implemented by pharmaceutical manufacturers.
In a report published through the Institute of Validation Technology (IVT), pharmaceutical researchers believe companies must evaluate their cleaning systems to comply with FDA regulations.
The FDA quality system model comprises of six key elements: quality, facilities and equipment, materials, production, laboratory controls and packaging and labelling.
The FDA guidelines detailed how improper cleaning of laboratory glassware can often be the defining factor for out-of-specification (OOS) analytical results.
It is advised, therefore, that all pharmaceutical companies must adhere to the explicit regulations to ensure a comprehensive cleaning system is maintained.
The research into current cleaning regimes has outlined the basic issues that cause concern for the industry, drawing attention to ‘areas of common sense’ that can be forgotten.
The document goes on to discuss how these areas can be easily manageable if maintenance and cleaning personnel are adhering to and enforcing all cleaning procedures.
To maintain a constant level of QC, the research suggested, it is essential to create a ‘written programme’ that follows the latest FDA guidelines, as this assures ‘cleaning processes are validated’.
To read the IVT research note, please click on the link above.
