Risk Assessment

In my current role as a QC team leader (Microbiology), ability to apply risk assessment principles, evaluate complex scientific and technical information and provide well thought out advice within a regulatory framework are the key skills required when approving (or rejecting) the QC release of a therapeutic product. My organisation may suffer great economic loss if a product is wrongly rejected; again, it may suffer both the loss of revenue and reputation if a faulty product is released incorrectly. Therefore, I must apply my sound judgement, logical and systematic approaches to making an evidence-based decision when accepting or rejecting a QC release and none of my decision taken so far went against the organisational business and reputation.
Then I prepared a GMP risk assessment identifying and evaluating potential risks in introducing a new API in manufacturing. As part of the risk assessment, I prepared a process flow where the new API may come into contact with personnel and the environment during sampling, QC testing, storage and manufacturing. I identified potential risks during any of these processes by evaluating complex scientific information, including chemical properties, MSDS, CoA and literature review for any reported hazard incidence and then analysed the risks in terms of likelihood and severity. For risk evaluation, I estimated the level of risk by combining the likelihood and severity and considering existing mitigating factors. Then I prepared risk control plans with mitigation strategies to reduce risks or control strategies to keep within acceptable limits. I also proposed for risk review events to enable the risk management to be reviewed in a timely manner. I enforced regulatory compliance in confirming the efficiency and consistency of the risk management plan. Then I provided my well thought out advice that the API can be stored in its specified status within the expiry date and can be used to manufacture safe product ensuring personnel health and environment safety. This risk management plan was submitted as part of the TGA registration
This plan was prepared for every single step of the manufacturing process, including administrative, manufacturing, environmental control, quality control and assurance, validation, packaging, warehousing and distribution. There were two versions of this risk assessment; the first one being a proactive approach, which was performed before introducing this product into the facility, the second version was performed retrospectively where I added in process issues. I performed exhaustive data analysis from three trial batches and three small GMP batches for quality control, validation, manufacturing controls and stability, which enabled me identifying, evaluating and controlling associated risks. Once more, this risk management plan was included in the HDP submission dossier. The application was successful, and the new product has already made over AUD two million in the first quarter of