Setting Risk Targets for Inspection of Pharmaceutical Companies in Low and Middle Income Countries: A Four Step Approach
Pharmaceutical companies are indispensable in providing essential medicines to the global population. However, in low and middle-income countries, the regulation of these companies is often insufficient, leading to risks of substandard, falsified, or counterfeit medicines. To ensure compliance and the delivery of safe and effective medicines, inspection of pharmaceutical companies is essential. The challenge, however, is to prioritize inspections based on risk, given limited resources.
To address this challenge, we discuss a four-step approach to setting risk targets for inspection of pharma companies in low and middle-income countries. This approach provides a structured and evidence-based process for identifying which companies should be inspected and how frequently. The four steps involved are:
Step 1: Identify Risk Factors
Identify the factors that increase the risk of substandard, falsified, or counterfeit medicines, such as the size of the company, the type of medicines produced, the quality management system, and the compliance history.
The first step of the approach is mainly to identify the risk factors involved in the manufacture and distribution of medicines. These risks may include the reputation of the company, the quality of the manufacturing processes, the availability of raw materials, and the accuracy of product information.
Step 2: Weight the Risks
The next step is to weigh these risks, so that the most significant risks can be prioritized. Assign a weight to each risk factor based on its impact on patient safety and public health. This can be done through a risk assessment process that considers the probability and severity of harm. Read “Essentials of Risk-Based Inspection”.
The regulation of pharmaceutical companies in low and middle-income countries is a crucial part of ensuring safe and effective medicines are available to the population. However, the limited resources available for inspecting these companies often means that inspections must be prioritized based on risk.
Step 3: Set Risk Thresholds
Establish risk thresholds that trigger an inspection based on the weighted risks. This can be done by defining the minimum threshold that a company must meet to avoid inspection, or by setting a maximum threshold that triggers an inspection. The level of quality management system implemented is one of the key determinants. These thresholds should be based on evidence and should be regularly reviewed and adjusted to reflect changes in the risk profile of the company.
Step 4: Adjust Risk Targets
Continuously monitor and adjust the risk targets based on new information and feedback. This can involve updating the risk factors, adjusting the weights, or changing the risk thresholds based on the results of inspections and other data sources.
The final step is to adjust the risk targets accordingly. This will ensure that resources are allocated to the most at-risk companies and that inspections are conducted at the most appropriate frequency.
Risk assessment is essential in order to identify areas of non-compliance and prioritize risks in pharmaceutical companies in low and middle-income countries. With this approach, risk targets can be set that will help to ensure the delivery of safe and effective medicines while also improving the efficiency of inspections by focusing on areas of highest risk.
Key Takeaways
- Pharmaceutical companies in low and middle-income countries need to be subject to frequent, comprehensive inspections to ensure compliance and the delivery of safe and effective medicines.
- The four steps outlined in this approach provide guidance on how to establish risk-based targets for inspection of pharmaceutical companies, mitigating risk of substandard, falsified or counterfeit medicines reaching the global population.
- The four-step approach to setting risk targets for inspection of pharmaceutical companies in low and middle-income countries is key to properly managing risk and ensuring safety.
- This approach involves identifying the factors that can contribute to substandard, falsified, or counterfeit medicines; assessing the risk associated with these factors; developing target inspection categories based on those risks; and finally, monitoring and evaluating the performance of inspections.
- Implementing this process can help ensure that the global population has access to safe and effective medications from reputable pharmaceutical companies.
Risk-based inspection approach provides a systematic and structured way of selecting sites for inspection. A four-step approach should be taken when setting risk targets for the inspection of pharmaceutical companies in low and middle income countries, including risk assessment, risk determination, target setting, and monitoring. This framework allows for a more effective use of resources and more efficient delivery of safe medicines to communities in need. Read more here!
Summary
Pharmaceutical companies must be adequately inspected to ensure the safety and efficacy of their products, particularly in low and middle-income countries where regulation may otherwise be inadequate.
Risk assessment is an essential component of ensuring the safety and efficacy of pharmaceutical products in pharma manufacturing. The process involves identifying potential hazards, evaluating the likelihood and severity of harm, and implementing measures to mitigate or eliminate risks. Read more here!
A four-step approach proposed in this article should be taken when setting risk-based targets for pharmaceutical company inspections, which includes assessing risk factors, benchmarking performance, establishing a target level, and monitoring performance over time. Maintaining proper oversight of pharmaceutical companies will help reduce the global burden of substandard, falsified or counterfeit medicines and improve the quality of care for people in low and middle-income countries.
What’s Next on PharmaRead.com
Bonus topic – Setting Risk Targets for Inspection of Pharmaceutical Companies in Low- and Middle- Income Countries: A Four Step Approach with Examples*
Risk assessment is essential in order to identify areas of non-compliance and prioritize risks in pharmaceutical companies in low and middle-income countries. A four step approach can be used to develop risk targets for inspection. The blog post will include examples including but not limited to: (1) identification of critical aspects, (2) definition of indicators, (3) determination of targets and thresholds, and (4) validation and integration into risk-based inspection systems. With this approach, risk targets can be set that will help to ensure the delivery of safe and effective medicines while also improving the efficiency of inspections by focusing on areas of highest risk.
*Bonus topics are selected based on our readers’ interest. You can read more in the future.
Disclaimer: The views and opinions expressed on PharmaRead are those of the authors and do not necessarily reflect the official policy or position of any agency or organization. PharmaRead articles are provided for information only with focus on global health, pharmacy practice, and healthcare systems in Low- and Middle-income Countries (LMICs). Readers should seek expert opinion for use, implementation or application of this knowledge based on their individual circumstances.
