Regulatory compliance in the pharmaceutical manufacturing sector is the observance of laws, guidelines, standards, and regulations set forth by governmental entities, regulatory bodies, and industry-specific organisations. This adherence is critical to uphold ethical practices, legal integrity, and responsibility in the production, distribution, and marketing of pharmaceuticals. It ensures the protection of public health and safety, while maintaining the quality, efficacy, and integrity of pharmaceutical products. Compliance with such regulatory frameworks, including those enforced by authorities like the MHRA in the UK, mitigates the risk of legal repercussions, fines, product recalls, reputational harm, and the potential loss of market access, thereby safeguarding both the organisation and its stakeholders.
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