Standard Operating Procedure for Cleaning Validation in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for validating the cleaning process of equipment and facilities used in gels production to ensure removal of residues and prevent cross-contamination.
2) Scope
This SOP applies to all personnel involved in cleaning validation activities within the pharmaceutical manufacturing facility’s gels production area.
3) Responsibilities
Quality Assurance (QA) Team: Develop and oversee the implementation of cleaning validation protocols.
Production Department: Perform cleaning procedures according to validated protocols.
Quality Control (QC) Team: Verify cleanliness through analytical testing and inspection.
Engineering Department: Maintain equipment to facilitate effective cleaning processes.
4) Procedure
4.1 Protocol Development
4.1.1 Define acceptance criteria for cleanliness based on product-specific requirements and regulatory guidelines.
4.1.2 Develop cleaning validation protocols including worst-case scenarios and sampling locations.
4.2 Pre-cleaning Procedures
4.2.1 Disassemble equipment and remove product residues, components, and accessories.
4.2.2 Clean surfaces manually or using automated cleaning systems with validated detergents and solvents.
4.3 Analytical Testing
4.3.1 Collect samples from critical surfaces and equipment parts post-cleaning.
4.3.2 Analyze samples for residual levels using validated analytical methods (e.g., HPLC, TOC).
4.4 Inspection and Verification
4.4.1 Conduct visual inspections to verify cleanliness and absence of residues.
4.4.2 Document inspection results and compare against acceptance criteria specified in the cleaning validation protocol.
4.5 Documentation and Reporting
4.5.1 Compile all data, including cleaning records, analytical results, and inspection findings.
4.5.2 Prepare a cleaning validation report summarizing the validation activities, results, and conclusions.
4.6 Revalidation
4.6.1 Perform periodic revalidation of cleaning procedures as per established schedules or in case of process changes.
4.6.2 Update cleaning validation protocols based on findings from revalidation exercises.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
HPLC: High-Performance Liquid Chromatography
TOC: Total Organic Carbon
6) Documents, if any
– Cleaning Validation Protocols
– Cleaning Records and Logs
– Cleaning Validation Reports
7) Reference, if any
– FDA Guidance for Industry: Cleaning Validation Guidelines
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– Company-specific cleaning validation procedures and policies
8) SOP Version
Version 1.0