Pharmaceutical Industries Quality Control SOP’s
General
- Quality Control – Principle, General information
- Sampling of Raw material and cleaning of sampling aids.
- Opening and Closing of the Quality Control Department
- Entry And Exit from Quality Control Department-SOP
- Control Sample Management-SOP
- Analytical Specifications, Standard Test Procedures and Worksheets – SOP
- Analysis of Raw Materials – SOP
- Handling of Raw Material Under Retest Due – SOP
- Disposal of Laboratory Waste – SOP
- Procurement and Handling of Reference Standards – SOP
- Preparation and Handling of Working Standards – SOP
- Column Management – SOP
- Shelf life of Volumetric Solutions – SOP
- Preparation, Standardisation and Storage of Laboratory Solutions – SOP
- Contract Laboratory Approval and Contract Analysis – SOP
- Analytical Method Validation SOP
- Calibration of Glass Apparatus SOP
- Inventory of Reagents/Indicators and Other Items SOP
- Handling of Hazardous Chemicals SOP
- Usage Entry on Log Books SOP
- Handling of The Spillage SOP
- Handling of Out Of Calibration (OOC) SOP
- Investigating and Handling Of Out Of Specification (OOS) Test Results SOP
- Investigating and Handling of Out Of Trend (OOT) Test Results SOP
- Audit Trail SOP
- Good Chromatographic Practices SOP
- Adjustment of Chromatographic Conditions as per BP / USP (for HPLC)
- Analyst Qualification SOP
- Good Laboratory Practice SOP
- Sampling, Testing and Release of Water and Pure Steam
- Testing and Release of In process samples, Semi Finished Products and Finished Product
- Analytical Method Transfer SOP (AMT)
- Rounding off Analytical Results SOP
- Good Laboratory Practice – GLP
Equipment
- Calibration of Analytical Balance SOP
- Calibration of Ultraviolet Visible Spectrophotometer SOP
- Calibration of High Performance Liquid Chromatography (HPLC) SOP
- Calibration of Fourier Transform Infra-red Spectrophotometer (FTIR) SOP
- Operation and Calibration of Karl Fischer Titrator SOP
- Operation of Digital Micrometer SOP
- Cleaning and Operation of COD Digester SOP
- Operation of Ultrasonic Cleaner SOP
- Operation and Calibration Of pH Meter/ Conductivity Meter
- Calibration Of Dissolution Test Apparatus SOP
- Operation and Calibration of Friability Test Apparatus SOP
- Operation and Calibration of Refractometer SOP (Make-Rajdhani)
- Operation and Calibration of Polarimeter SOP (Make-Rajdhani)
- Operation and Calibration Of UV Cabinet SOP
- Operation and Calibration of Hot Air Oven SOP
- Operation of Reverse Laminar Air Flow Unit SOP
- Operation of Micrometer Screw Gauge SOP
- Operation and Calibration of Disintegration Test Apparatus SOP
- Operation of Dissolution Test Apparatus SOP
- Operation of High Performance Liquid Chromatography (HPLC) SOP
- Operation of Viscometer SOP
- SOP of Desiccator
- Electrolab Disintegration Test Apparatus SOP
- Electrolab Friability Test Apparatus SOP
- SOP for Operation and Calibration of Total Organic Carbon analyzer. (TOC)
- Tap Density Tester SOP
- SOP for Hardness Tester
- Calibration of Gas Chromatography SOP
- SOP for Bursting Strength Tester
