SOP
- Change Control
- Hold Time Study Protocol
- CRITICAL AND MAJOR DEFICIENCIES
- GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies”
- Isolators In Pharma Industry
- INSPECTIONS/AUDITS
- ELECTRONIC RECORDS
- Water Analysis as per IP/BP/USP
- RESOURCES-THE QUALITY SYSTEMS MODEL
- MANUFACTURING-THE QUALITY SYSTEMS MODEL
- MANAGEMENT RESPONSIBILITY-THE QUALITY SYSTEMS MODEL
- CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS
- EVALUATION ACTIVITIES – THE QUALITY SYSTEMS MODEL
- USFDA Guidance on Quality Metrics
- Quality Measures
- HPLC troubleshooting
- Change management As Per WHO TRS1019 Annex 3
- Quality Metrics in pharmaceutical industry
- Reference-Standard and Working Standards
- REMEDIATION OF DATA INTEGRITY FAILURES
- Classification of data integrity deficiencies
- Out of Specification & Out of Trend Investigations as per MHRA
- HPLC Interview Questions
- Microbiological Efficacy of the Cycle
- Microbiological Monitoring of the Environment
- TOOLS FOR QUALITY IMPROVEMENT PART – I
- Human Errors
- What are the different types of Quality Management systems (QMS)?
- What is future mapping?
- OUT OF SPECIFICATIONS (OOS)
- SOP for Quality Assurance Policy
- ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION
- RISK MANAGEMENT METHODOLOGY – ICH Q9
- TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9
- DRUGS AND COSMETICS ACT, 1940 FOR MEDICINE
- SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
- Validation Questions on cleaning validation (APICS)
- Cleaning process Control
- Operation, cleaning and maintenance of Static Pass Box.
- STERILITY ASSURANCE
- Functioning, cleaning and maintenance of Dynamic Pass Box
- Functioning, cleaning and maintenance of Sterile Garment Cabinet
- SOP on Operation, Calibration, Cleaning and Maintenance of LAF
- Market complaints and product recall
- SOP on Document Management System in Quality Assurance Department.
- EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS
- DOCUMENTATION IN PHARMACEUTICAL
- Cleaning validation Principle Appendix 3 (WHO Guideline)
- PERSONNEL HYGIENE
- Quality Risk Management in Analytical Laboratory
- Change Control
- Hold Time Study Protocol
- CRITICAL AND MAJOR DEFICIENCIES
- GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies”
- INSPECTIONS/AUDITS
- ELECTRONIC RECORDS
- RESOURCES-THE QUALITY SYSTEMS MODEL
- MANUFACTURING-THE QUALITY SYSTEMS MODEL
- MANAGEMENT RESPONSIBILITY-THE QUALITY SYSTEMS MODEL
- CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS
- EVALUATION ACTIVITIES – THE QUALITY SYSTEMS MODEL
- USFDA Guidance on Quality Metrics
- Quality Measures
- Change management As Per WHO TRS1019 Annex 3
- Quality Metrics in pharmaceutical industry
- REMEDIATION OF DATA INTEGRITY FAILURES
- Classification of data integrity deficiencies
- Out of Specification & Out of Trend Investigations as per MHRA
- TOOLS FOR QUALITY IMPROVEMENT PART – I
- Human Errors
- What are the different types of Quality Management systems (QMS)?
- What is future mapping?
- OUT OF SPECIFICATIONS (OOS)
- SOP for Quality Assurance Policy
- ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION
- RISK MANAGEMENT METHODOLOGY – ICH Q9
- TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9
- DRUGS AND COSMETICS ACT, 1940 FOR MEDICINE
- Validation Questions on cleaning validation (APICS)
- Cleaning process Control
- Market complaints and product recall
- SOP on Document Management System in Quality Assurance Department.
- EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS
- DOCUMENTATION IN PHARMACEUTICAL
- Cleaning validation Principle Appendix 3 (WHO Guideline)
- PERSONNEL HYGIENE
- Standard/non-standard processes
- Process validation scheme
- Process validation (Continuous process verification) for finished products
- Qualified Person
- DRUG DESIGN (AN OVERVIEW)
- CHANGE CONTROL
- Quality Management System
- HAZARD ANALYSIS OF CRITICAL CONTROL POINT (HACCP)
- Meanings of terms
- HACCP VALIDATION REPORT
- Interview Questions & Answers (Quality Assurance)
- Observations & Compliances response of GMP Inspections
- ANVISA – The Brazilian Health Surveillance Agency
- New Product Design and Development Process
- Water Analysis as per IP/BP/USP
- HPLC troubleshooting
- Reference-Standard and Working Standards
- HPLC Interview Questions
- SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
- Quality Risk Management in Analytical Laboratory
- IMPURITIES IN NEW DRUG SUBSTANCES
- HPLC (Questions & answers)
- Dissolution (Question & Answer)
- OOS (Out of Specification) As PER USFDA & MHRA
- SOP on Sampling of Raw Material
- SOP FOR STABILITY STUDY IN PHARMA INDUSTRY
- Total Organic Carbon in Water in Pharma Industry
- Checklist for QC Audit in Pharma Industry
- Indian Pharmacopoeia Commission (IPC)
- SOP FOR BUBBLE POINT TEST
- SOP For Analytical Method Validation protocol
- All Post URL of Drugs formulations
- Cleaning Validation – Glossary of Terms
- QC SOPs List
- SOP on calibration of pH meter
- PROCEDURE FOR CALIBRATION OF REFRIGERATOR
- List of Documents required for Pharma Quality Control Departments (GMP & GLP Compliances)
- SAMPLING OF PACKING MATERIALS
- STABILITY STUDY PROTOCOL
- SOP on the Transfer of Technology for Analytical Method
- SOP on cleaning and operating procedure of bursting strength tester
- 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)
- Calibration of KARL FISCHER (METTLER TOLEDO)
- Calibration procedure for friability test apparatus
- 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 SAS SUPER 100 AIR SAMPLER
- 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)
- Procedure for operation of Autotitrator (METTLER TOLEDO). Quality assurance
- PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC)
- Procedure for calibration of balance XS 204 DR.
- Preparation, hahdling, storage and discard of mobile phases
- SOP For Procedure for calibration of Autotitrator (METTLER TOLEDO)
- SOP For Calibration procedure for pH meter
- Procedure for calibration of HPLC (WATERS ALLIANCES)
- Procedure for operation of IR Spectrophotometer (SHIMADZU)