MHRA

This article serves as a comprehensive framework to ensure compliance with regulatory standards set by the Medicines and Healthcare products Regulatory Agency (MHRA) and other governing bodies. This SOP outlines systematic steps for obtaining, maintaining, and renewing licenses for pharmaceutical products, focusing on Good Manufacturing Practice (GMP), quality assurance, and legal adherence. Key components include the preparation of the Common Technical Document (CTD), facility inspections, quality control processes, and rigorous risk management practices. The SOP also emphasizes interdepartmental collaboration—integrating roles from regulatory affairs, quality assurance, legal teams, and pharmacovigilance to ensure the product meets safety, efficacy, and quality standards. By adhering to this SOP, pharmaceutical companies can streamline the licensing process, mitigate risks, and uphold their commitment to public health and regulatory compliance in the UK market.