Important SOPs for Quality Control Department (Chemical section) in Pharmaceutical Industry
- Sampling of raw material, packaging material, bulk, intermediate and finished product
- Raw material, packaging material, bulk, intermediate and finished product analysis
- Cleaning and storage of sampling equipment
- Preparation of specifications
- Procurement of laboratory chemicals
- Collection, retention and destruction of reference and retention samples
- Procurement, handling and storage of reference standards
- Preparation, handling and storage of working standards
- Cleaning of laboratory glassware and accessories
- Calibration of laboratory glassware
- Preparation and standardization of volumetric solution
- Sampling and analysis of purified water
- Labelling of reagents and chemicals
- Rinse water analysis
- Cleaning, operation and calibration of balances
- Operation and calibration of polarimeter
- Operation and calibration of Karl Fischer auto-titrator
- Operation and calibration of pH meter
- Operation and calibration of melting point apparatus
- Operation and calibration of vacuum oven
- Operation and calibration of refractometer
- Operation and calibration of UV-VIS spectrophotometer
- Operation and calibration of HPLC
- Operation and calibration of Vernier
- Handling of quality control note book, logs and work sheets
- Preparation of buffer solution
- Handling and management of HPLC columns
- Calibration of UV cabinet
- Operation and calibration of bursting strength apparatus
- SOP on analytical method validation
- SOP on analytical method verification
- SOP on analytical method transfer
- Operation of hot plate
- SOP on Good Laboratory practices
- Preparation of specifications
- SOP on out of specification
- Handling of instrument breakdown
- SOP on operation and calibration of dissolution apparatus
- Temperature mapping of stability chamber
- Operation and maintenance of stability chamber
- Temperature mapping of refrigerators
- Handling of hazardous substances in QC laboratory
- SOP on retesting of raw materials
- SOP on handling laboratory incident
- Calibration and validation schedule of QC instruments
- Calibration of temperature monitoring devices
- Preparation of certificate of analysis
- Handling of laboratory waste materials
- Operation and calibration of IR spectroscopy
- Operation and calibration of Gas chromatography
- Qualification of QC chemist
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