Risk Assessment in pharma

The most effective guideline to perform the risk assessment is ICH Q9., where given the
appropriate methodology for risk assessment. Risk Assessment is most effective tool to identify
the risk evaluation of process operation, operation procedure, analysis procedure, control
parameters, production failure, equipment failure etc.

Principles of Risk Assessment:

To perform and evaluate the risk to quality shall be performed based on the scientific
knowledge, practical experiences, threw the review of production process, control checks,
probability of malfunction in process parameters, and affected parameters due to malfunction.

Risk Assessment Process:

Risk assessment shall be performed based on following question, but not limited to:
To identify the probability of risk
To analysis the risk, which types of risk to be occurred?
To evaluate the risk and which affected up to what extended
What and how control checks or tools to be implementing for reduction or prevent the risk?
How and up to what extended risk can be allow?
Finally to review the risk assessment report frequently or when as change to be proposed.

Responsibilities for assessment the risk

In general, Quality unites will be responsible to assessment the risk. But however it is not
mandatory. Risk assessment to be performed with the help of concerned department. Who have
the scientific knowledge, practical experience of system, operation, procedure etc. it can be
done with the quality management system, where experts from the different areas will together
to identify, evaluate and make effective system and control to reduce the probable risk.

What are the basic question to be ask for risk identification, evaluation and prevent
What might be wrong in process?
What is the probability to go wrong?
What are the possibilities of the consequences?

Risk identification:
It is a systematic use of information to find out the hazards which referring to the risk or
problem. Risk identification can be done based on the historical data, theoretical analysis data,
collect the information from direct concerned personnel who are perform the activity, which
need to evaluate the risk.

Risk Analysis:
To make the effective qualitative or quantitative system or analysis tools, which give the help to
identify the defect in process or like hood occurrence? The analysis tools must have the
capability to detect, management and control on identified risk.

Risk Evaluation:
To compare the identified and analyzed risk against the risk criteria. Risk assessment to be
either a quantitative estimate of risk or a qualitative description of range of risk. Risk can be
determined as “Significant”, “Minor”, “Moderate”, “Major” and “Catastrophic” or “High”,
“Medium” and “Low”. Risk assessment can be done based on the RPN number “Risk
Probability Number”. In RPN, methodology, each risk category to be define in ascending
number as 1, 2, 3, 4, 5 or 1, 2 and 3 as respective above categories.

Equation for Risk Assessment: Risk = consequences or like hood x RPN of severity
(Maximum is 5 x 5 = 25)

Identified risk or process shall be evaluate based on following statically tools

Example for Risk Assessment
Consequences or like hood RPN Number (severity)
Significant 1
Minor 2
Moderate 3
Major 4
Catastrophic 5

If the identified risk is fall significant, then risk of severity shall be as 1, which indicate the risk
to be very less. If the identified risk is fall Catastrophic, then risk of severity shall be as 5, which
indicate the risk to be very high, hence the preventive action to be taken to reduce the
consequences of identified risk. Finally submission to be done for all identified consequences to
get the cumulative RPN number. Calculated RPN number should not be more than 25. if it is,
then strong corrective action to be taken to prevent or reduce the risk.

Risk Assessment in Pharmaceutical industries will be done based on following non-

exhaustive tools
FEMA : Failure Mode Effects Analysis
FEMECA : Failure Mode, Effects and Criticality Analysis
FTA : Fault Tree Analysis
HACCP : Hazard Analysis and Critical Control Points
HAZOP : Hazard Operability Analysis
PHA : Preliminary Hazard Analysis