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High-Impact Areas for Regulatory Compliance in Pharmaceutical Manufacturing and Quality Assurance

Ensuring regulatory compliance in pharmaceutical manufacturing is critical for maintaining product quality, safety, and efficacy. The following key areas highlight essential practices and regulations that pharmaceutical companies must adhere to: GMP (Good Manufacturing Practices) Compliance Strict adherence to GMP (Good Manufacturing Practices) regulations is crucial for quality assurance in pharmaceutical manufacturing. GMP standards ensure that […]

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Minimum Regulatory Functions required for Drug Regulatory Authorities in LMICs

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Drug regulatory authorities (DRAs) in low- and middle-income countries (LMICs) must focus on a set of core functions to ensure safe, effective, and high-quality medicines are available to their populations. Minimum (essential) Regulatory functions Regulatory authorities in LMICs may face specific challenges such as limited resources, lack of infrastructure, and insufficient technical expertise. Strategies to […]