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Strengthening the Risk-based Self-inspection Programs In LMICs: The Role Of Pharmaceutical Manufacturers

In Low- and Middle-Income Countries (LMICs), ensuring the quality, safety, and efficacy of pharmaceutical products is crucial to protect public health. One important aspect of maintaining high-quality standards is to reduce regulatory burden through self-inspection programs conducted by pharmaceutical manufacturers. These programs aim to identify and address any potential risks or vulnerabilities within their manufacturing […]

Setting Risk Targets for Inspection of Pharmaceutical Companies in Low and Middle Income Countries: A Four Step Approach

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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, […]