Standard Operating Procedure for Validation of Automatic Ointment/Cream Filling Machine

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the validation of the automatic ointment/cream filling machine used in the formulation of cutaneous products. It aims to ensure that the machine consistently delivers accurate fill volumes, meets regulatory requirements, and maintains product quality and safety.

Scope

This SOP applies to all personnel involved in the validation, operation, and maintenance of the automatic ointment/cream filling machine in the formulation, manufacturing, and processing of creams, ointments, gels, and other cutaneous formulations.

Responsibilities

• Production Operators: Responsible for assisting in the validation process and operating the filling machine in accordance with established procedures.
• Quality Assurance (QA): Responsible for overseeing the validation activities, verifying compliance with regulatory requirements, and ensuring product quality.
• Engineering Department: Responsible for performing the validation of the filling machine, including equipment qualification and process validation.
• Supervisors: Responsible for coordinating the validation activities and ensuring that all personnel adhere to safety protocols.

Procedure

1. Preparation: Ensure that the automatic ointment/cream filling machine is installed and set up according to the manufacturer’s instructions.
2. Documentation Review: Review the equipment manuals, specifications, and validation protocols to understand the validation requirements and acceptance criteria.
3. Equipment Qualification: Perform installation qualification (IQ) to verify that the filling