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Every pharmaceutical product being manufactured is likely to have risks. In order to protect patients from these risks, a quality system, and manufacturing practices is important. It is very critical to maintain the quality of a product from the time it's being manufactured, through its shelf-life until it is consumed by a patient.
The application of this process must be systematic in its operations in the identification of a risk based on scientific knowledge. It should be comprehensively designed and correctly implemented to achieve efficient results. The aim of this process is to ensure proper product quality and sustained assurance of consumer's safety while using the product. If the process is carried out effectively there should be increased assurance of quality and cost saving in the industry.
PROCEDURE INVOLVED
The whole procedure is carried out in the following steps;
i. Risks assessment
It involves assessing the concerned industries in order to identify the possible risks that might emerge. It combines both the qualitative and quantitative methods in the determination of possible risks.
ii. Risk identification
This is where risks are identified and isolated to facilitate the analyzing process. Identification is done on the collected data presented by a particular industry. This step is very important and failure to identify the correct risks might lead to implementation of wrong solutions and control measures.
iii. Risk analysis
- Provides a comprehensive analysis at the end of the procedure.
- The risks are analyzed quantitatively and qualitatively.
- The risks are then analyzed in terms of probability and severity.
iv. Risk evaluation
Comparison between the risks identified and analysed against a standard risk criteria is done. The result will outline the extent and degree of severity or probability of occurrence of a risk.
v. Controlling risks
This involves measures that will help minimize the risks once they are evaluated. Detection methods are then employed to analyze whether the control process is successful or not.
vi. Reviewing the identified risks
A proper system should be used to ensure consistence in a routine review. This specializes in monitoring the results of the risk management process. Appropriate and successful procedure will result in proper cost and time management hence economical to the industry.
RISK AREAS TO MANAGE
- Product development
- Laboratory control and stability tests
- Manufacturing process
- Raw materials used
- Manufacturing facilities
- Inspection process
- Distribution of the product
- Storage facilities
- Patient possession and use of pharmaceutical products
RISK MANAGEMENT TOOLS
These tools are used to organize data and steps taken to minimize or control risks hence facilitates appropriate decision making. The most commonly used tools are major management facilitation methods including the use of flowcharts and supporting statistical tools
RISK MANAGEMENT APPROACH
In a pharmaceutical industry, this responsibility is predominantly assigned to the risk management program manager. The manager together with the team comes up with systematic approaches to tackle the risks and eliminate them. The approach to the risks identified specifies the manner in which they will be handled.
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