Risk Management in Pharmaceuticals

Risk management in pharmaceuticals is the systematic process of identifying, assessing, and prioritizing potential risks associated with the development, production, and distribution of drugs, and implementing measures to mitigate these risks. This involves identifying and assessing the potential risks associated with each stage of the drug development process, from the initial discovery and development of new compounds to the post-market monitoring of drugs once they are on the market. Risk mitigation strategies may include changes to the drug’s formulation, manufacturing processes, labeling, or distribution methods, as well as increased monitoring and clinical testing. The goal of risk management in pharmaceuticals is to ensure that drugs are safe and effective for patients, while also balancing the risks and benefits of these products.


  1. Define the risk management requirements regarding identifying, assessing, prioritizing, mitigating, monitoring, and communicating risks that have a direct impact on product safety, quality, efficacy & purity to meet ICH Q9 & WHO requirements.
  2. Provide an effective, pure & safe product to the patients. Focusing our efforts and resources on the things that provide quality assurance to our customers & safety to our employees.


  1. This SOP applies to Liquid Injectables, Dry powder for suspension, capsules, & Sachet, Quality Control, and Material Management Department.

HSE Statement:



  1. Q.A department is overall responsible for the implementation of this SOP.




Quality risk management

Quality risk management is a systematic process for the identification, assessment and control of risks to the quality of pharmaceutical products across the product lifecycle.”

Risk = Probability X Severity


Possible consequences of hazards in a process


The taking of all necessary actions to ensure and maintain compliance with the criteria established in the HACCP plan.

Corrective action

Any action to be taken when the results of monitoring at the CCP indicate a loss of control

Critical control point (CCP)

A step at which control can be applied and is essential to prevent or eliminate a pharmaceutical quality hazard or reduce it to an acceptable level

HACCP plan

A document prepared in accordance with the principles of HACCP to ensure the control of hazards which are significant for pharmaceutical quality in the production and supply chain.


Any circumstance in the production & Quality of a product which can cause an adverse effect on the health of patient

Hazard analysis

The process of collecting and evaluating information on hazards which should be addressed in the HACCP plan

Flow Chart:-



Principles of Quality Risk Management

Two primary principles,

  1. The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient & this all can be done by doing the process mapping of Critical Control Points involved in a process.
  2. After doing Process Mapping the hazards analysis of these critical control points should be done and controlled by implementing all those standard process which are made for that specific step to prevent the product from all those hazards.

Risk Management Methodology

Process Mapping

Risk Management in Pharmaceuticals should include systematic processes designed to coordinate, facilitate and improve science-based decision making with respect to risk. Possible steps used to initiate and plan a quality risk management process.

Hazard Analysis and Critical Control Points (HACCP)

HACCP is a systematic method for the identification, assessment and control of safety hazards. Such hazards are defined as biological, chemical, or physical agents or operations that are reasonably likely to cause illness or injury if not controlled. In the manufacture of certain antibiotics, or other highly active pharmaceuticals, together with operations such as fluidbed drying, granulation is an example of hazard unit operations. The use of inflammable solvents (solutions) and certain laboratory operations may also constitute hazards.

HACCP 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.

Principle Of HACCP

The HACCP system is based on seven principles.

  • Conduct a hazard analysis.
  • Determine the critical control points (CCPs) through Process Mapping.
  • Establish target levels and critical limit(s).
  • Establish a system to monitor the CCPs.
  • Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
  • Establish procedures to verify that the HACCP system is working effectively.
  • Establish documentation concerning all procedures and keep records appropriate to these principles and their application.

Application Of HACCP

The application of HACCP principles consists of the following stages:-

  • Assemble a HACCP team
  • Describe the product and process
  • Identify the intended use
  • Construct a flow diagram
  • On-site confirmation of flow diagram
  • List all Potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards
  • Determine critical control points
  • Establish critical limit for each CCP
  • Establish corrective actions
  • Establish a monitoring system for each CCP
  • Establish verification procedure
  • Establish documentation & record keeping

Quality Risk Management As A Part of Development

  • To design a quality product and its manufacturing process to consistently deliver the intended performance of the product (ICH Q8)To enhance knowledge of product performance over a wide range of material attributes (e.g., particle size distribution, moisture content, flow properties), processing options, and process parameters
  • To assess the critical attributes of raw materials, solvents, active pharmaceutical ingredient (API) starting materials, APIs, excipients, or packaging materials
  • To establish appropriate specifications, identify critical process parameters, and establish manufacturing controls (e.g., using information from pharmaceutical development studies regarding the clinical significance of quality attributes and the ability to control them during processing)
  • To decrease variability of quality attributes:
    • reduce product and material defects
    • reduce manufacturing defects
  • To assess the need for additional studies (e.g., bioequivalence, stability) relating to scale up and technology transfer


  1. Process Mapping for Quality Rick Management.
  2. Quality Rick Management through HACCP.


  1. Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials. Volume2. Good manufacturing practices and inspection. Geneva, World Health Organization,1999.


This SOP has to be distributed in below mentioned Departments:-

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