What you learn:
- Identify GMP/GHP requirements relevant to manufacturing.
- Apply best practices to reduce contamination risks.
- Integrate GMP/GHP with HACCP controls and QA activities.
Description:
Learn the principles of Good Manufacturing Practices and Good Hygiene Practices, covering facility design, process control, sanitation, and personnel behavior that impact safety and quality.
Cleaning and Sanitation Objectives
Cleaning removes soil and residual contaminants, while sanitation reduces microbial load to safe levels. Programs should specify objectives, responsibilities, frequency, and validated procedures designed for each area and equipment type. Segregate responsibilities to minimize cross contact and ensure effective sanitation cycles across the facility.
Methods and Practices
Use CIP for automated cleaning and COP for manual cleaning in areas where automation is not feasible. Choose detergents and sanitizers compatible with surfaces and residues. Establish rinse sequences, temperatures, and contact times that achieve the required cleanliness without leaving harmful residues.
Verification and Validation
Validate cleaning procedures by testing surfaces and equipment after cleaning. Use rapid indicators such as ATP tests and microbiological swabs to confirm effectiveness. Schedule routine verification and adjust programs based on findings and trends.
Documentation
Document cleaning SOPs, chemical inventories, safety data sheets, dilution procedures, and verification results. Maintain logs for each cleaning cycle and ensure records are readily retrievable for audits and investigations.