Post by Microchem Laboratory

Want to see a list of all our main elements of GMP compliance? The number of processes we run to be a top-tier lab might surprise you. This list comes from a crosswalk table we maintain for auditors. It points them to the relevant Microchem Laboratory SOP for each element of GMP compliance. It takes a lot of time, effort, and financial resources to build and run a comprehensive system like this, but we do it because we love quality, and we love generating data our clients can trust! We have a list for GLP compliance too 😉 Quality Manual Document Control Procedure Record Retention Organizational Structure and Responsibilities Responsibilities of Quality Unit Internal Audit Program Management Review Personnel & Training Job Descriptions Training Program Training Records GMP Training Gowning Practices Safety Facilities & Environmental Controls Facility Layout Controlled Environments Environmental Monitoring Program Cleaning and Sanitization Procedures Pest Control Program Utilities Equipment & Instrumentation Equipment Qualification Calibration Program Preventive Maintenance Schedule Equipment Logs Temperature Mapping Temperature Monitoring Out-of-Tolerance Handling Laboratory Controls Written Test Methods Method Suitability Culture Media Preparation Sterility of Media Reagents Labeled, controlled, etc. Positive/Negative Controls Sample Management Sample Receipt Procedure Chain of Custody Sample Storage Conditions Sample Identification and Traceability Sample Retention Policy Data Integrity & Documentation ALCOA+ Principles Corrections Documented Properly Electronic systems validated, if applicable Backup and Data Security Measures Deviations, OOS, and CAPA Deviation Management System Out of Specification Procedure Root Cause Procedure CAPA System Formal Change Control Process Impact Assessments Performed Changes Approved Prior to Implementation Method and Non-Method Development (Validations) Materials Management Supplier Qualification Program Material Receipt Material Inspection and Release Inventory Control Storage Conditions Materials Traceability Microbiology-Specific Controls Microbial Identification Culture Handling and Storage Conditions Incubation Conditions Defined and Verified Cross-Contamination Prevention Measures Plate Incubation Traceability Reporting & Client Interface Review and Approval of Results Data Review Process Client Communication Handling of Client Complaints Risk Management Risk Management Process If your company hasn't checked us out for routine, GMP-compliant chemistry and microbiology, now's a great time to start: https://lnkd.in/ePZbXRe9 https://lnkd.in/g-wu639q