Huma Ali et al.

/ Journal of Pharmacy Research 2011,4(6),1909-1910

Research Article Available online through
ISSN: 0974-6943 http://jprsolutions.info
Risk assessment & management in pharmaceutical industries:
Vital requirement to ensure product quality
Huma Ali * 1 and Rajesh Hajela 2
1
Senior Executive Department of Quality Assurance Rusan Pharma Ltd Kandla Gandhidham kutch Gujrat -370201 India.
2
Deputy General Manager Quality Assurance & Technical Rusan Pharma Ltd Kandla Gandhidham kutch Gujrat -370201 India.
Received on: 11-02-2011; Revised on: 16-03-2011; Accepted on:21-04-2011
ABSTRACT
Risk assessment is science-based, systematic, identifies specific hazards and measures for their control, as well as providing information on environmental
protection and labor safety. The purpose of risk assessment is effects of every process laid down in the different requirement stages should be investigated and
assessed in order to guarantee perfect product that comply with the specifications and GMP norms. The present article is aimed at assisting industry to provide,
develop and implementation effective HACCP or risk assessment strategy covering activities such as research and development, sourcing of materials, manufac-
turing, packaging, testing and distribution for direct and indirect effects on the product quality. We should encourage open risk aware culture to understand risk
always exist and to identify opportunities for improvement.

KEY WORDS:Risk assessment, risk management, risk control, risk communications, pharmaceutical safety.

INTRODUCTION
“Quality risk management is a systematic process for the assessment, control, Overview of a typical quality risk management process 3
communication and review of risks to the quality of the medicinal product
across the product lifecycle.” Traditionally, the Hazard Analysis and Critical
Control Point (HACCP) methodology has been considered to be a pharmaceu-
tical safety management system. It aims to prevent known hazards and to
reduce the risks that they will occur at specific points in the manufacturing
chain. The same principles are also increasingly being applied in other indus-
tries, such as chemical industry and food industries. Risk affecting quality are
controlled to a certain extent through the validation of critical operations and
processes in the manufacture of finished pharmaceutical products in accor-
dance with Good Manufacturing Practices (GMP). However, GMP does not
cover the safety of the personnel engaged in manufacture, while both aspects
are covered by risk assessment methodology or Hazard Analysis and Critical
Control Point (HACCP) methodology. The purpose of risk assessment is
effects of every process laid down in the different requirement stages should be
investigated and assessed in order to guarantee perfect product that comply
with the specifications and GMP norms. Risk assessment or HACCP should
not be confused with validation since its approach is broader; it thereby helps
to identify matters on which validation should concentrate. It is science-based
and systematic, and identifies specific hazards and measures for their control,
as well as providing information on environmental protection and labor safety.
Risk assessment is a tool to assess hazards and establish control systems that
focus on prevention rather than relying on corrective action based on end
product testing. All risk assessment or HACCP systems are capable of accom-
modating changes, such as advances in equipment design and processing proce-
(ICHQ9)
dures or technological developments. Its application may be used as a first
step towards cGMP. The present article is aimed at assisting industry to pro- Initiating a Risk Management Process:
vide, develop and implementation effective HACCP or risk assessment strat- Identify the area which Risk is related to. The risk may the related to Product,
egy covering activities such as research and development, sourcing of materi- Process, Procedure, Equipment, Instrument, Starting Material, Facility, Envi-
als, manufacturing, packaging, testing and distribution for direct and indirect ronment Controls, or others like team has no expertise, aviability of resources
effects on the product quality. that can do particular tasks .As per principle of Failure Mode Effect Analysis
(FMEA), try to methodically break down the complex process (risk) into man-
PROCEDURE: ageable steps (function or sub-function) to proceed for risk management for risk
A model for quality risk management is outlined in the diagram below. The by creating a watch list each individual steps.
emphasis on each component of the framework might differ from case to
case. Risk Assessment:

Identification of Risk Scenario:

*Corresponding author. Identify the potential risks associated with a particular function or sub-function,
with aid of question: ‘What might go wrong?’ This provides the basis for further
Huma Ali
steps in the quality risk management process. Identify tasks which your team
Senior Executive Department of Quality Assurance have no expertise and identify situations where you have limited number of
Rusan Pharma Ltd Kandla resources that can do a particular task.
Gandhidham Kutch Gujarat -370201 India.
Risk Analysis:
Risk analysis is the estimation of the risk associated with the identified hazards.
It is the process of linking the likelihood of occurrence and severity of harms.

Journal of Pharmacy Research Vol.4.Issue 6. June 2011 1909-1910

 Huma Ali et al. / Journal of Pharmacy Research 2011,4(6),1909-1910
Risk Likelihood (frequency or probability of occurrence)
This stage is to determine ‘What is the likelihood (probability) it will go wrong?’
Determine the likelihood against each identified risk. A method of representing
this is as Low (L), Medium (M) or High (H) that is determined depending on the
system or the function and its applicability. For e. g. :
Low Frequency of the event occurring is perceived to be once per 10000; or Probabili
ty of events occurring is less (one event in a year)
Medium Frequency of the event occurring is perceived to be once per 1000; or Probability
of events occurring is sometimes (two to three events in a year).
High Frequency of the event occurring is perceived to be once per 100; or Probability
of events occurring is high (more than 3 events in a year)
Based on the Risk Likelihood & Severity of risk, identify the risk class as Class
1, Class 2 or Class 3 as per Table No. 1.
Risk Severity Impact or Significance
This stage is to determine ‘What are the consequences (severity)? Risk assess-
ment requires not only the identification of the immediate effects of the risk but
also the long term and widespread impact of those effects. These effects must
take into account a wide variety of issues including impact on regulatory com-
pliance. Impact on Patient safety, product quality and data integrity (or other
harm) may be considered. Determine the likelihood against each identified risk.
A method of representing this is as per as Low (L), Medium (M) or High (H).
Low Expected to have a minor negative impact. The damage would not be expected to
have a long term detrimental effect.
Medium Expected to have a moderate impact. The impact could be expected to have short to
medium term detrimental effects.
High Expected to have a very significant negative impact. The impact could be expected
to have significant long-term effects and potentially catastrophic short-term ef
fects.
Risk Classification (Risk Class)
Based on the Risk Likelihood & Severity of risk, identify the risk class as Class
1, Class 2 or Class 3 as per below table (Table No.1 )
Table 1 Risk Likelihood
Risk severity
Low Medium High
High
Risk Class 1
Risk Class
Medium Risk Class 2
Low Risk Class 3
Probability of Detection (Detectability)
The purpose of this stage is to identify if the risk event is recognized or
detected by other means in the system. If Class 1 risk, has a high probability of
detection may not pose such a serious threat because it can be recognized
quickly and suitable corrective actions can be taken to mitigate its impact.
Conversely, if the same fault has low probability of detection then one needs
to seriously consider review of the design or the implementation of alternate
procedures to avoid the event. Assign the Detectibility as Low (L), Medium
(M) or High (H).
Source of support: Nil, Conflict of interest: None Declared
Journal of Pharmacy Research Vol.4.Issue 6. June 2011
Low: Detection of the fault condition is perceived to be unlikely.
Medium: Detection of the fault condition is perceived to be reasonably
likely.
High: Detection of the fault condition is perceived to be highly likely.
Risk Priority :
Based on the Risk Classification & Probability of Detection, identify the risk
priority as High, Medium or Low as per Table 2.
Table 2:
Detectability
High Medium Low
High Priority
Class 1
Medium Priority
Class 2
Low Priority
Class 3
Risk Control (Mitigation):
Mitigation seeks to reduce probable cause and consequences of an adverse risk to
an acceptable threshold by taking actions ahead of time, thereby decreasing the
likelihood of the problem occurring. It is effective to reduce the probability of
a risk even occurring then trying to repair consequences after it has occurred.2
Once the priorities have been determined, methodically breakdown and group
the risks based on class and priority, define and document appropriate measure(s)
for mitigation. Risk Mitigation may include, but not limited to one or more of
Design of Process, Facility, Utilities, etc. automation,systemic control (SOP,
Procedures)
Risk Acceptance:
Based on the risk control measures, determine the risk acceptance for each
group and provide the inference.
Action Plan:
Provide in detail action plan to implement the risk control measures.
Risk management tools & Risk communications:
Risk management tools very helpful to manage risk. Risk management tools are
flow charts, check sheets, Failure Mode Effect Analysis (FMEA), Fault Tree
Analysis, Risk ranking and filtering , Hazards Analysis and Critical Control
Points (HACCP), Supporting statistical tools. The out put or results of the
quality risk management process should be appropriately communicated and
documented.
CONCLUSION:
The evaluation of risk to quality should be based on scientific knowledge and
ultimately link to the patient. The level of effort, formality and documentation
of the quality risk management process should be commensurate with the level
of risk. Effective quality risk management can facilitate better and more in-
formed decisions, provide regulators with greater assurance of a company’s
ability to deal with potential risks, and might affect the extent and level of
direct regulatory oversight. We should encourage open risk aware culture to
understand risk always exist and to identify opportunities for improvement.1
REFERENCE:
1. http://www.david-begg-associates.com
2. www.abb.com/service
3. Q9 ICH Guidelines
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