Risk assessment methods and how to do Risk assessment

What is Risk assessment?  Why is it done in Pharmaceutical Manufacturing? 

How to do risk assessment? Which method is best for Risk assessment? 

Risk assessment is an important tool in pharmaceutical manufacturing to have a clear picture or a clear idea of the risks associated with everything in a pharmaceutical manufacturing company be it manufacturing, equipment of premises or accessories, and the strategy to eliminate these risks.

For example, a manufacturing process that requires filling of a sterile dosage form requires an environment free of microbial bacterial and fungal contamination. But the HEPA filter itself has an efficiency of 99.997 % that means there is a probability of 0.003 % of contaminated air contaminating the filling area. You will get such detailed technical information about pharmaceutical manufacturing pharma times journal.

The area where sterile dosage form is filled is Class A area provided with Laminar air flow bench, the air filtered through HEPA filter is blown over the product in rectangular to product so that any contamination will be swept away. The surrounding area of a sterile filling area is Class B area and microbial count limit for the area is No growth on the Settle plate, air sampled. 

In this case the risks are as follows. 

1.Risk: Contamination of the product with bacterial fungal contaminants. 

2.Failure Situation: 1. Failure in cleaning and sanitization. 2. Equipment failure due to electricity failure. 3.Mitigation Strategy 1) Ensure proper cleaning and sanitization has occurred, validation of the cleaning and sanitization procedure to ensure that the procedure is giving complete protection. 2) Electricity backup with capacity completes the production batch independently in the event of power failure. Cross check the backup is ready before starting to fill. 3) Periodic media fill run to keep check on the effectiveness. 

4) Microbiological and environment monitoring at the point of filling, with a settle plate as well as active air sampling method and contact plate method. 

Monitor the mitigation strategy adapted on a daily basis for its effective execution. When these things are properly written down, reviewed and signed a documentary evidence is readily available for taking appropriate steps which will reduce the risk. 

The process is called risk assessment. 

Following are some tools for conducting risk assessment. 

Failure mode effects analysis. (FMEA) 

Failure mode effects and Criticality analysis. (FMECA) 

Fault tree method Hazard analysis and critical control points. (HACCP) 

Quantitative Microbiological Risk assessment (QMRA ) 

Out of these tools (FMEA) (FMECA) (HACCP) is widely used in Pharma industry