Pharmaceutical Manufacturing Steps for Production of Medicines
Few industries are as stringent about manufacturing standards and procedures than pharmaceutical. One small error could thwart an entire batch of drugs and cost their manufacturer time and money.
Before any drug can be mass produced, it must undergo intensive clinical testing on animals and humans alike.
Research and Development
Prior to manufacturing medicine, pharmaceutical manufacturers must undergo stringent animal and human trials in order to evaluate its safety and efficacy. While this research can be costly and time consuming, it is vital for bringing new drugs onto the market.
Private spending on drug R&D has steadily increased over the years, following an initial brief pause. Yet balancing R&D needs with lower costs and improved production efficiency is often challenging.
Pharma manufacturers are constantly searching for ways to increase workflow productivity and decrease errors. Digital tools and techniques offer them the means of accomplishing this objective, with 42% of pharma manufacturers reporting that effective lab data management will have the greatest impact on their business growth in the next five years.
Additionally, efficient production methods are necessary to meet the ever-increasing demand for affordable generics and innovative medicines – this is where advanced technologies such as AI can bring significant advantages.
AI can significantly cut development times through improved target validation, accelerate clinical trial design through biomarker-based screening, and cut development costs with in silico database-trained methods. As pharmaceutical manufacturing grows more complex, artificial intelligence’s application has become ever more essential if manufacturers want to remain cost competitive and increase productivity. Data analytics plays an increasingly vital role in helping this industry use advanced technology efficiently.
Formulation is a critical element of pharmaceutical manufacturing. This process entails mixing the active drug ingredient with other ingredients to form a final dosage form such as tablets, capsules or injections. Formulation must be precise and accurate while being subjected to extensive testing – such as assessments on safety and effectiveness as well as considerations such as particle size distribution, form, moisture content, surface roughness/cohesion properties as well as powder flow properties.
Once a drug has been created, it must undergo rigorous animal and human trials to ensure its safety and efficacy before going on sale. Unfortunately, due to highly regulated processes in the pharmaceutical industry, taking so long may delay new treatments reaching market.
Technological advancements are compelling pharmaceutical manufacturers to reevaluate their approaches to production. For instance, they are increasingly employing digital tools and continuously operating processes – which allows them to produce drugs more efficiently while increasing operational stability.
They are moving toward hub-and-spoke models that allow them to decrease dependence on one facility while increasing resilience of supply chains in times of emergency, such as during the COVID-19 pandemic. This could prevent shortages in medicines during an outbreak.
Pharmaceutical production involves mass synthesis of medicines on an industrial scale, producing drugs in tablets, capsules or injections for patient consumption. As this is an expensive process that puts patient safety first, pharmaceutical technical operations are heavily regulated by health agencies; many prefer time-tested models over newer approaches that have yet to prove themselves over decades.
Pharmaceutical companies must also ensure they can produce their drugs on a large scale, known as scaling up, which is an integral part of drug development. Scaling up allows pharma companies to evaluate their products on a larger scale and establish whether they comply with regulatory standards.
At this stage, manufacturers depend on a steady supply of raw materials that may cause delays if there is an unexpected surge in demand. The COVID-19 pandemic illustrated how fragile drug supply chains are and caused shortages across the world. With advanced production technology available today, however, this risk can be reduced by decentralising manufacturing operations using hub-and-spoke models, allowing a company to produce across different sites simultaneously rather than over relying on one facility alone.
Continuous processing techniques can also increase productivity. By eliminating workflow bottlenecks and responding quickly to shifts in production focus (for instance, making vaccines to combat virus spread), continuous processing techniques allow pharmaceutical companies to become more responsive.
Pharmaceutical industries place great emphasis on safety and sterility when packaging medicines, making specific methods necessary. From research and development to production and packaging processes, specific procedures must be implemented so as to meet regulatory bodies’ demands in healthcare industry. Therefore, manufacturers of pharma products must adapt their production processes in order to comply with any demands made on them from this sector.
Rockwell Automation recently published a report outlining how an integrated approach to quality assurance in pharmaceutical manufacturing facilities could help drive operational efficiency while responding quickly to sudden demands, like those related to COVID-19 vaccine production. This will enable production focus shifts quickly in response to sudden events like COVID-19 vaccination needs.
To increase productivity of a pharmaceutical packaging line, custom-made machines that offer flexible solutions may be beneficial in increasing productivity. Such machines may accommodate liquid, powder or solid pharmaceuticals for packaging allowing greater flexibility and speed as well as reduced labor, material and operating costs – leading to reduced product recall risk and improving customer satisfaction resulting in higher profitability for pharmaceutical manufacturers.