SOP (Standard Operating Procedures)
Process
- Preparation of Procedures for Operation, Cleaning and Preventive Maintenance
- Preparation of Procedures for Environment Monitoring
- Preparation of Procedures for Calibration of Master Instruments and Process Instruments
- Preparation of Calibration Schedules – Equipment wise
- Preparation of procedures for Operation, Cleaning, Sterilization, Disinfection, Sanitization & Monitoring
- Preparation of procedures for Gowning & De-Gowning
- Preparation of procedures for Personnel Hygiene Monitoring and control
- Preparation of procedures for Area Monitoring and control
Quality Control
- Review of Instrument Qualification Protocols & Monitoring of Commissioning Activities
- Preparation of Instrument Calibration Schedule and Monitoring of Calibration Activities
- Preparation of Procedures for Testing Activities of Water, Nitrogen, Raw Materials, In Process Material, Packing Material and Finished Products
- Preparation of Procedures for Testing Activities of MLT/ Bio burden in Purified Water, WFI, Pure steam, Raw Materials & Product
- Preparation of Procedures for Testing Activities of BET in Purified Water, WFI, Pure Steam, Raw Materials and Product
- Preparation of Procedures for Testing Activities of Product Sterility Testing
- Preparation of Procedures of Media Preparation, Sterilization, Plate Preparation, Exposure Activities
- Preparation of Procedures of Culture Suspension Activities & Organism Identification
- Preparation of Standard Test Procedures, General Procedures, Stability Specifications and Other Miscellaneous Test Procedures
- Preparation of Procedures of Biological Indicator Qualification & Handling
- Preparation of Procedures of Incubation & Inspection Activities
- Training to Concerned Persons, Monitoring of Execution and Review of Reports
- Preparation and Develop the Disinfectants Validation Protocols, Monitoring the Execution and Review the Reports
Warehouse
- Preparation of Procedures for Goods Receiving, Storage, Segregation, Sampling, Dispensing and Issuance
- Preparation of Procedures for Monitoring /recording of Storage condition
- Preparation of Procedures for storage of Finished Goods