Risk assessment and management

Risk assessment Risk management process in pharma:

Adapting the Risk assessment Risk management procedure in a pharmaceutical manufacturing firm is the process towards compliance of FDA guidelines issued by US FDA, accepting the existence of a risk is not bad but not making any remedial strategy to reduce the effects of risk, not making the plan to eliminate the risk is bad. And not documenting the present risks is a threat to the quality of product, which may arise and become a serious concern with respect to regulatory and healthcare concerns.

Therefore every pharmaceutical company is required to assess the kind of risks to which the company and products are exposed to. After knowing that there are so many risks and the gravity of the risk, there should be a mitigation strategy planned to eliminate the risks identified.

Regulatory agencies approve risk assessment as a step towards establishing quality of product manufactured. With the establishing a risk assessment and mitigation strategy quality assurance of the product quality is considered in accordance with EU GMP guidelines Annex 1, Revision 12.

Risk assessment should be subjected to product life cycle approach, analyzing the risk at each step at manufacturing and also periodic risk assessment exercises and gathering data to support decisions taken for risk assessment and mitigation strategy.

Risk management: Remedial actions may reduce stop or slow down or alter the method of the activity or the frequency of the activities which impart risk on the company or product, or just monitor the activity with the purpose of reducing the risk.

Risk assessment team: To ascertain a risk team doing risk assessment should include individuals having deeper understanding of the manufacturing environment, along with individuals from quality assurance.

Risk assessment tools: Risk is identified by use of systematic documented approach to precisely identify the most probable risk and most potential consequences, by considering past information, statistical data and risk pointed out during brainstorming sessions.

Asking as many questions about what could create a risk to process and product and gathering answers in systematic manner, rating them with probability of identifying in event of occurrence and their severity, is covered in the tools used for risk assessment in pharma. After identification of the risk along with its severity and probability of occurrence and detectability factor, the risk is compared with set of risk criteria using a quantitative or qualitative scale to form an acceptable threshold level. Risks are rated as high, medium and low in a qualitative manner and a number is assigned based on their severity, detectability and probability of occurrence.

Risk mitigation strategy:

1. After a risk is identified a formal communication, education, training is provided to all concerned so that they are aware of the risk.

2. A system is designed to identify the risk. If it occurs, the likelihood of identifying the risk is increased, so that the further consequences can be prevented.

3. A mitigation strategy in event of risk occurs and goes undetected, a strategy to mitigate risk at all possible levels should be formed and maintained.

What to do if the risk identified is low rating and easily detectable with detection methods training in place and the probability of the occurrence is very very low or nil.

In such a situation, there is no need to do anything since such risks are already put under control.

Following tools are used to do risk analysis

HACCP allowing tools are used to do risk analysis. HACCP

FMEA
Risk Priority Number (RPN)
We will provide details about how to do risk assessment by HACCP, RPN, FMEA, FEMCA.