Standard Operating Procedure for Cleaning Validation in Creams Production

1) Purpose

The purpose of this SOP is to define procedures for cleaning validation in creams production to ensure equipment cleanliness and prevent cross-contamination.

2) Scope

This SOP applies to all equipment used in creams production and outlines the process for validating cleaning procedures to meet regulatory requirements and maintain product quality.

3) Responsibilities

It is the responsibility of the Quality Assurance (QA) department to oversee cleaning validation activities. Production personnel are responsible for executing cleaning procedures and providing necessary documentation.

4) Procedure

4.1 Cleaning Validation Protocol Preparation

4.1.1 Develop a cleaning validation protocol outlining the objectives, acceptance criteria, sampling methods, and analytical procedures.

4.1.2 Identify worst-case scenarios and critical equipment parts for validation based on product characteristics and manufacturing processes.

4.1.3 Obtain approval of the cleaning validation protocol from QA before proceeding with validation activities.

4.2 Pre-Cleaning Procedures

4.2.1 Ensure equipment is visually clean and free from residues before initiating cleaning validation.

4.2.2 Disassemble equipment components as necessary to facilitate thorough cleaning and sampling.

4.2.3 Label and document equipment parts and sampling locations for traceability during validation.

4.3 Cleaning Procedure Execution

4.3.1 Follow approved cleaning procedures, including the use of appropriate cleaning agents, equipment, and cleaning cycles.

4.3.2 Conduct cleaning verification to