Assessing Risk in Sterile Manufacturing

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:

  1. Evaluation should be based on scientific knowledge and linked to product protection
  2. 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.
  • What could go wrong?
  • What is the cause?
  • What are the consequences?
Risk Analysis The qualitative or quantitative consideration of the risks identified.
  • How great is the probability of the risk occurring?
  • How great is the probability of the risk being detected?
  • How serious are the consequences?


Risk Control The decision whether to accept and/or minimize a risk.
  • Is the risk nominal and can, therefore, be accepted?
  • Can the risk be eliminated or reduced to an acceptable level through mitigating measures?
  • What is the appropriate balance among the benefits, risks and resources?
Risk Communication Sharing of information about risk and risk management between the decision makers and others.
  • Have all impacted parties been notified of the output/results of the risk assessment?
Reviews Review or monitoring of output/results of the risk management process considering new knowledge and experience about the risk.
  • Are new risks introduced as a result of the identified risks being controlled?
  • Have process / system / product / equipment / facility / utility changes introduced new risks or affected prior risk acceptance decisions?

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.


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