The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure (SOP) for Regulatory Audits and Inspections Purpose: The purpose of this SOP is to provide guidelines for conducting and managing regulatory audits and inspections to ensure compliance with applicable regulations and standards. This SOP aims to establish a systematic approach for preparing, conducting, and responding to regulatory audits and inspections effectively. Scope:…
Standard Operating Procedure SOP for Regulatory Change Control Purpose: The purpose of this SOP is to establish a structured process for managing and controlling changes to regulatory requirements, procedures, and documents, ensuring compliance with applicable regulations, and minimizing the risk of non-compliance. Scope: This SOP applies to all regulatory changes within the organization, including changes…
Standard Operating Procedure for Regulatory Document Control Purpose: The purpose of this SOP is to establish a systematic approach for the control, management, and maintenance of regulatory documents within the organization, ensuring accuracy, version control, and accessibility for regulatory compliance. Scope: This SOP applies to all regulatory documents generated, received, or utilized by the organization,…