The world of Regulatory Affairs is fast-moving and fluid.
However, one constant remains throughout the industry – the overwhelming need for best practice to be in place at all times to sustain public safety, wellbeing, and confidence in the products brought to market.
This key element is achieved through the implementation and maintenance of ‘current Good Manufacturing Practice’ (cGMP) by regulatory bodies. Unlike standards and regulations in other industries, cGMP is a process of continual improvement that is constantly evolving and responding to a wide variety of factors and new technologies.
cGMPs cover every aspect of pharma and biotech to assure proper design, monitoring, and control of manufacturing processes and facilities as well as the identity, strength, quality, and effectiveness of the product being produced.
They also set the standard for robust quality management systems, raw material selection, strong operating procedures and quality control throughout the entire design, manufacture, testing and distribution processes.
The proper utilisation and safeguarding of these procedures are essential in preventing instances of contamination, mix-ups, deviations, failures, and errors.
Furthermore, due to the insistence on the GMPs being utilised as ‘current’, all technology, research and systems being employed by companies must be completely up to date and of the highest standard to ensure they comply fully with the expected regulations.
This requires constant improvement by companies and innovative thought as well as sustained investment in research and technology to ensure they remain compliant with the progressive cGMPs. Companies must be ready at all times to integrate new regulations swiftly into existing processes.
cGMPs offer consumers peace of mind that the product they are using is safe and has been manufactured and tested to exacting standards.
However, it is important to remember that many pharma and biotech companies already take these standards so seriously that they view cGMPs as the minimum requirements and make huge efforts to exceed them in their quality and risk management systems.
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