SELF INSPECTION CHECKLIST FOR QC
General Checklist:
- General cleanliness of department and cleaning records
- Storage condition of chemicals and solvents
- Labeling status on bench reagents / volumetric solutions /working standards and their preparation & utilization records
- Sampling procedure of raw materials / packaging materials as per SOP
- Labeling of raw material samples /packaging materials samples after sampling procedure
- Availability of raw material / in process / finished product / packaging materials specifications and testing procedures
- Documentation of raw data, and preparation of final analytical reports
- Good Documentation Practices
- Re-testing schedule of raw materials /Packaging materials
- Storage of retain samples of raw materials / finished products
- Records maintained for destruction of raw materials / finished products sample after analysis.
- Approved vendor list of raw materials / packaging materials
- Disposal of organic solvents/ residual /retain samples
- Disposal of organic solvents/ residual /retain samples
INSTRUMENTATION SECTION
- Overall cleanliness of instruments and records
- Calibration status of instruments and records
- Qualification / Validation reports of instruments
- Operation and Calibration procedure for each instruments
- Temperature records of all oven / Refrigerator
- Column performance checking of HPLC /GC
MICROBIOLOGY SECTION:
- Good Documentation Practices
- Records of department cleaning and Disinfection
- Cleaning of equipments and records
- Validation status of autoclave, incubators / oven and records.
- Records for Manometer reading of laminar air flow
- Records maintained for plate exposure in production area
- Records maintained for water analysis
- Temperature and humidity records of microbiology lab
- Media preparation records
- Growth promotion Test (GPT) records