BIOTECH & PHARMACEUTICAL
Increased market competition coupled with stringent regulatory compliance, make enterprise risk management within the biotech and pharmaceutical space an absolute necessity. The consequences of less-than-optimum quality management within the pharmaceutical and biotech industries can be devastating. Johnson and Johnson were subject to several product recalls in 2010, including a situation where Children’s Tylenol was recalled due to contamination with a water based bacteria. In another case, although there were several mitigating circumstances surrounding Pan Pharmaceutical’s demise, the initial incident that caused the Therapeutic Goods Administration to take action against them was a severe lapse in their validating processes concerning the travel sickness drug, Travacalm.
THINK SAVVY knows that the implications of sub-standard quality control and risk management processes within these industries can be detrimental not just in terms of cost, but also in the context of reputational damage about your company.
Monitoring internal processes, ensuring correct labelling practices, preventing cross contamination, maintaining adherence to Process Validation Guidelines, generating optimum value from your CRO’s (Clinical Research Organisations) and CMO’s (Contract Manufacturing Organisations) are all critical risk factors that need to be managed to ensure a high-quality end product and compliance with ever-changing regulatory requirements. To find out how our technology solutions can apply to your organisation why not invite us to come and learn about your requirements so we can better understand your priorities.
The Good Manufacturing Process states that ‘quality must be built into each batch of product during all stages of the manufacturing process’. But how can you be certain that this is the case with every raw material that you receive, or every product that you manufacture? Although there were a number of mitigating circumstances surrounding Pan Pharmaceutical’s demise, the initial incident that caused the TGA to take action against them was a severe lapse in their validating processes concerning the travel sickness drug, Travacalm. It could possibly be the case that Pan Pharmaceuticals may have avoided bankruptcy if this lapse in their quality control and risk management processes had not occurred.
Enterprise Risk Management permeates every area of both the pharmaceutical and biotech industries. Imagine the consequences of sub-standard quality control regarding an aspect of your product or service delivery that could have been prevented?
Add all of the above to the considerations of occupational health and safety risks, environmental risks, financial risks such as extortion and fraud, and supply chain risks and the process of managing risk within the biotech and pharmaceutical industry can be rather daunting.
But can you imagine what it would be like if all of your staff were aware of the risks associated with your operations, and were accountable for the management of these risks?
What would it be like if your facility was so well managed in terms of risk that it was subject to reduced TGA inspection frequency; would this be useful to you in terms of saving time, minimising stress and saving money?
We, here at THINK SAVVY, understand that this sounds almost too good to be true. An easy to use compliance monitoring system and risk management process that can help you manage almost all of the internal and external risk factors associated with your pharmaceutical or biotech facility, that can possibly save you money and mitigate reputational risk.
Would it be useful to you to have a risk management plan in place, and an auditing system that was so scientifically advanced that it could identify high performers within your organisation, along with those whose performance has some potential for improvement?