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This document outlines the procedure for conducting periodic self-inspections in accordance with current Good Manufacturing Practices (cGMP) to ensure compliance across all departments of the formulation plant. It details the responsibilities, procedures, audit reporting, and corrective actions required following inspections.
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A standard operating procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization.
Typically, any department or individual that is involved in standardized processes within an organization is required to develop and file standard operating procedures.
To fill out a standard operating procedure, one should follow a template that includes sections such as title, purpose, scope, responsibilities, procedure details, and review dates, ensuring clarity and completeness in each section.
The purpose of a standard operating procedure is to ensure consistency and efficiency in operations, promote safety, and provide clear instructions for employees to follow.
An SOP must include the title, identification number, version, effective date, purpose, scope, responsibilities, detailed procedures, and any relevant references.
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