SOP
- Good Manufacturing Practice for Medicinal Products -Questions and answers
- Product Quality Review -Questions and answers
- Quality Assurance (QA) Quiz No.1
- Quality Assurance (QA) Quiz No.2
- QMS Document Review
- Validation of Pharmaceuticals: Ensuring Quality, Safety, and Compliance
- QUALITY MANAGEMENT SYSTEM IN PHARMA
- Market Complaint -Stages of Handling
- QUALITY BY DESIGN AND SCALE – UP
- Retrospective Validation
- Quality Excellence & Quality Culture Check
- ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR)
- Quality inspection (Self-inspections & Benefits of Self Inspection)
- Checklist for Do’s and Don’ts for Dissolution Analysis
- Checklist for Do’s and Don’ts for Using Glassware for Analysis
- Checklist for Do’s and Don’ts for Sample preparation of temperature / light-sensitive material and product
- DO’s & DON’Ts For Column care to avoid/Minimize incidences
- Checklist for Precautions during Sample Dilution /preparations in Wet Labs
- SOP On SOP – Initiation of new SOP In Pharma Industry
- REGULATORY IMPACT ON OOS
- OOS RECORDING PROCEDURE
- SECONDARY WORKING STANDARDS
- BET and sterility validation of microbiology
- Process validation protocol
- GMP Inspection HPLC Checklist
- Change Management in Pharma
- 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 Chromatography troubleshooting
- Change management
- 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
- OOS RECORDING PROCEDURE
- SECONDARY WORKING STANDARDS
- Process validation protocol
- Change Management in Pharma
- 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
- 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
- POST-APPROVAL CHANGE MANAGEMENT PROTOCOL (PACMP)
- 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 PHARMA
- WHO TRS1019 Appendix 3 – Cleaning validation Principle
- 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
- 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
- Humidity Chamber
- 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)
- SOP on Procedure for microbiological monitoring of Purified water in pharmaceutical company
- SOP on Sampling of raw materials in pharmaceutical company
- SOP on Samping of packing materials in Pharmaceutical company
- SOP on Procedure for cleaning and storage of sampling devices
- SOP on Procedure for operation of HPLC (waters-alliance)
- SOP on Procedure for operation of analytical balance
- SOP on Operating procedure for tap density apparatus make : electrolab
- SOP on Operating procedure for sieve shaker in quality control
- Collection, Storage and Control of Control Samples for Drug Products
- SOP on Handling of Primary Standard
- Stability study of volumetric solution
- Good Laboratory Practices (GLP)
- SOP on Analyst Qualification in quality control
- SOP on handling of Out of trend (OOT)
- SOP on procurement and handling of working standards
- SOP on Procedure of volumetric solution preparation and standardization
- SOP on Procedure for sampling of raw material
- SOP on calibration of glassware