SELF INSPECTION CHECKLIST FOR QC

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

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