📈Stability Studies Design & Reporting |
Develop and document comprehensive stability studies. |
Draft protocols, manage data collection templates, and create reports. |
✅Data Integrity & Compliance in QC |
Ensure compliance with data integrity requirements. |
Create SOPs, audit trails, and data review checklists. |
📊OOS, OOT & OOE Management |
Support investigations for OOS, OOT, and OOE results. |
Draft investigation templates, CAPA plans, and review reports. |
🧪Raw Material & Component Testing Compliance |
Ensure testing aligns with regulatory standards. |
Create specifications, testing protocols, and compliance assessments. |
📝Evaluation and Reporting of Results |
Provide a robust approach for monitoring the validity of results |
Establish statistical methodologies to implement decision rules for determining reportable results |
🌱Environmental Monitoring |
Ensure a controlled and compliant environment across the entire manufacturing premises. |
Develop monitoring plans, establish sampling strategies, and create data trending reports. |
🛠️Environmental Monitoring Program Implementation |
Set up comprehensive environmental monitoring systems. |
Draft SOPs, define sampling points, and implement monitoring tools. |
💧Purified Water System Monitoring |
Document and monitor water quality compliance. |
Develop water sampling plans, testing schedules, and log templates. |
🔬Microbial Identification & Testing |
Support microbial testing with detailed documentation. |
Prepare identification protocols, result templates, and validation reports. |
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Ensure testing complies with microbial limits. |
Draft testing protocols, result forms, and compliance reports |
🚨Sterility Testing & Aseptic Process Monitoring |
Support sterility assurance programs. |
Develop sterility test protocols, monitoring plans, and reporting templates. |
