Pharmaceutical Guidance Complete Pharma Solution
- SOP on Testing Efficacy of Disinfectants
- SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area
- SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area
- SOP on Viable Particle Monitoring of Drain Points– Sterile Product Manufacturing Facility
- SOP on calibration of pH meter
- Sampling and testing of Sterile surgical Gloves
- PROCEDURE FOR CALIBRATION OF REFRIGERATOR
- USFDA GUIDELINE FOR DRUG QUALITY SAMPLING AND TESTING (DQST)- HUMAN DRUGS
- List of Documents required for Quality Control Departments (GMP & GLP Compliances)
- List of Documents required for Quality Assurance Departments (GMP Compliances)
- In-process control of oral drug product during manufacturing & Packing
- SAMPLING OF PACKING MATERIALS
- PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER
- Batch Release Statement for Pharmaceutical Product
- Procedure for Microbiological Monitoring of Purified water
- Inprocess Control of Packing Lines
- Sampling of Intermediates and Finished Products
- Inprocess Control During Tablets Manufacturing
- SOP on Line Clearance
- SOP on the Transfer of Technology for Analytical Method
- SOP on Transfer of Technology for Manufacturing process
- SOP on Fogging of Microbiology Testing Areas
- SOP on cleaning and operating procedure of bursting strength tester
- Handling of Microbiological Data Deviation in Microbiology Laboratory
- Calibration procedure for tap density apparatus [Make- electro Lab]. Quality assurance
- Procedure for operation and calibration of IR Spectro Photometer (SHIMADZU). Quality assurance
- Procedure for calibration of conductivity meter (PICO). Quality Assurance
- Calibration of KARL FISCHER (METTLER TOLEDO). Quality assurance
- Calibration procedure for friability test apparatus. Quality assurance
- Calibration procedure for disintegration test apparatus (ED-2AL)
- Procedure for operation of weighing balance (Make: METTLER TOLEDO)
- Procedure for operation of pH / CONDUCTIVITY METTLER (PICO)
- Operating procedure for milli Q water system
- Procedure for operation of walk in humidity chamber (25ºC/60%RH)
- Operating procedure for ultrasonic bath
- Calibration procedure for gas chromatograph clarus 500 with head space (Perkin Elmer)
- Area clearance during batch/product change over in Pilot Production facility. Quality Assurance
- Preparation, Approval and Control of Guidelines (Quality Assurance)
- Technology transfer
- Correction of Documentation Errors
- New Product Design and Development Process
- Approval of vendors (Packing Materials)
- Vendor Development and Approval (API and excipients)
- Cleaning validation
- Procedure for operation of Autotitrator (METTLER TOLEDO). Quality assurance
- PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC)
- PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER
- Unit Dose Sampling Procedure for Blend Uniformity
- Management Review
- Temperature Mapping