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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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What is standard operating procedure?
A standard operating procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization.
Who is required to file standard operating procedure?
Typically, any department or individual that is involved in standardized processes within an organization is required to develop and file standard operating procedures.
How to fill out standard operating procedure?
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.
What is the purpose of standard operating procedure?
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.
What information must be reported on standard operating procedure?
An SOP must include the title, identification number, version, effective date, purpose, scope, responsibilities, detailed procedures, and any relevant references.
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