SOP

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

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• 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

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• 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)

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