Berkshire Sterile Manufacturing
by Andrea Wagner, Ph.D.
In a recent training at Berkshire Sterile, the topic of risk assessment was covered – a very important subject with FDA and others, such as international clients. In this training, Berkshire Sterile assessed risk in relation to cGMP manufacture for our clients.
At Berkshire Sterile we look at risk to systems or processes or even the client drug/medical device product. We provide sterile manufacturing and therefore we are in a high risk category (i.e. the highest). The two primary principles of risk management are:
- Evaluation should be based on scientific knowledge and linked to product protection
- The level of effort/formality/ and documentation should be proportional to the level of risk to the product.
General Guidance for Risk Management
|Risk Management Process Step||Purpose||Questions to Consider|
|Risk Identification||The systematic examination of information to reveal risks.||
|Risk Analysis||The qualitative or quantitative consideration of the risks identified.||
|Risk Control||The decision whether to accept and/or minimize a risk.||
|Risk Communication||Sharing of information about risk and risk management between the decision makers and others.||
|Reviews||Review or monitoring of output/results of the risk management process considering new knowledge and experience about the risk.||
The elements outlined above were employed in determining pathways to assess the risks of activities at BSM as well as heighten and assign certain controls if necessary. More information regarding the FDA’s policies on Risk Assessment can be found here. BSM‘s process is just one of many that exists, but it gives a good backbone to looking at systems, processes, and changes and considering all aspects of how those items can increase or decrease risk to BSM’s clients’ products.