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 ensure removal of residues through visual inspection and swab sampling.
4.3.3 Document all cleaning activities, including cleaning agents used, cleaning time, and personnel involved.
4.4 Sampling and Analysis
4.4.1 Collect swab samples from critical equipment surfaces as per the cleaning validation protocol.
4.4.2 Analyze swab samples using validated analytical methods to quantify residual levels of active ingredients, cleaning agents, and microbial contaminants.
4.4.3 Compare analytical results against acceptance criteria specified in the cleaning validation protocol.
4.5 Reporting and Documentation
4.5.1 Prepare a cleaning validation report summarizing protocol adherence, results of cleaning verification and sampling, and analytical findings.
4.5.2 Include conclusions and recommendations for equipment cleaning procedures based on validation results.
4.5.3 Obtain QA approval of the cleaning validation report before equipment is released for use in creams production.
5) Abbreviations, if any
QA: Quality Assurance
SOP: Standard Operating Procedure
6) Documents, if any
Cleaning Validation Protocol
Cleaning Records
Cleaning Validation Report
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0