Quality Assurance
- Total Quality Management Practices
- GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance
- Management of Clinical Supplies
- Assigning Manufacturing and Expiry date to the Finished Products
- Internal Audit and Self Inspection
- Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products
- HOLD TIME STUDY FOR DISPENSED MATERIAL, INTERMEDIATES AND FINISHED PRODUCTS
- QUALITY AGREEMENT OF MANUFACTURE AND SUPPLY
- Guideline for Process Validation
- GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance
- Stability (ICH Q1A) Quiz 7
- Stability (ICH Q1A) Quiz 6
- Stability (ICH Q1A) Quiz 5
- Stability (ICH Q1A) Quiz 4
- Stability (ICH Q1A) Quiz 3
- Stability (ICH Q1A) Quiz 2
- Stability (ICH Q1A) Quiz 1
- Quality Risk Management -Questions and answers
- Pharmaceutical Quality System – Questions and answers
- 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)
- SOP On SOP – Initiation of new SOP In Pharma Industry
- REGULATORY IMPACT ON OOS
- 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
Microbiology
- BET and sterility validation of microbiology
- Isolators In Pharma Industry
- Microbiological Efficacy of the Cycle
- Microbiological Monitoring of the Environment
- 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
- Effectiveness of Antimicrobial Preservatives in Pharma industry
- All Post URL of Drugs formulations
- UV LAMP EFFICACY TEST
- UV efficacy Challenge test
- 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
- Sampling and testing of Sterile surgical Gloves
- Procedure for Microbiological Monitoring of Purified water
- Why disinfectant sterilization required in pharma injectable?
- SOP on Fogging of Microbiology Testing Areas
- Handling of Microbiological Data Deviation in Microbiology Laboratory
- SOP on OOS in microbiology
- DISINFECTANT VALIDATION
- PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM
- SOP for environmental monitoring of air
- SOP on Procedure for viable air monitoring in pharmaceutical company
- SOP on Media Preparation
- SOP on operation, cleaning and maintenance of the Stericheck system
- SOP of Hot Air Oven
- SOP of Vortex mixer
- SOP of Media Decontamination and Disposal after used
- SOP of LAL Reagent
- SOP of Temperature Monitoring of Microbiology Equipments
- SOP of Total Viable Spore Count Test for Biological Indicators
- SOP of Culture Suspension Preparation and Preservation
- SOP on Media growth Promotion, Inhibition and Sterility Check
- SOP of Reference cultures Maintenance and usage
- SOP on Viable Particulate Monitoring – Sterility Testing
- SOP on Viable Particulate Monitoring – MLT Testing
- SOP Sterile Garment Cabinet operation, cleaning and maintenance
- SOP of LAF Operation, Calibration, Cleaning and Maintenance
- SOP of Gram Staining
- SOP on Dry Bath Incubator Operation, Temperature verification, cleaning and maintenance
- SOP of Spore Staining
- SOP on Motility test
- SOP of General Safety in Microbiology
- SOP on Disinfectants Preparation and Usage
- SOP on Microscope Operation, Cleaning and Maintenance
- SOP in Microbiology for operation, cleaning and maintenance of Fogger
Validation
- Enhancing Efficiency with Automatic Rotary Type Measuring Cup Placement
- Revolutionizing Product Packaging with Bottle Sticker Labelling Machines
- Turn Tables Boosting Efficiency : Streamlining Material Handling and Process Optimization
- Unlocking Success with User Requirement Specification: Coating Machine URS
- Optimal HVAC Systems for Non-Sterile Pharmaceutical Environments: Ensuring Quality and Compliance
- Temperature mapping of storage areas: Ensuring Reliable Environmental Control and Compliance
- Vial Washing Machine: Streamlining Sterile Pharmaceutical Packaging
- Design Qualification of Gelatin Colour Mixer
- Installation Qualification of Gelatin Storage Vessel
- Principles of HVAC Duct Design in Pharma Industry
- Process Validation: General Principles (USFDA) in Pharma Industry
- Establishment of a Control Procedure in Pharma for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals
- Qualification of existing facilities, systems, equipment and utilities
- All Post URL of Drugs formulations
- Qualification & Validation of Equipment, Systems, Utilities in Pharmaceuticals
- PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM
- Guidance Document Cleaning Validation
- Non-sterile process validation
- Performace Qualification Protocol of Dispensing Booth
- Pharma Factory Acceptance Test for Automatic Strip Packing Machine
- SOP for Performance Qualification for Automatic Strip Packing Machine
- SOP for Performance Qualification for Auto Coater 48’’ GMP Model
- SOP FOR COMPUTER SYSTEM VALIDATION MASTER PLAN
- Compression Machine FAT (Factory Acceptance Test)
- OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT
- INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT
- DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM
- Validation Observations Recording Format -I for steam steriliser and load Pattern
- Performance Qualification Report for steam steriliser
- Load Pattern & Justification for steam sterilizer
- Protocol for steam sterilizer and load Pattern
- Installation qualification for purified water generation system
- Alu Alu Blister Pack Machine
- Process Validation Guidance: FDA and Global
- New EU Requirements for Qualification & Validation
- Concept of URS,DQ,IQ,OQ,PQ in Pharma
- Documentation in cleaning validation
- Validation of Cleaning Processes
- Levels of Cleaning in cleaning Validation
- Validation of Sterilization Process in Autoclave
- Qualification For Stability Chamber ( STABILITY DATA ACQUSITION SOFTWARE)
- DISINFECTANT VALIDATION
- PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM
- Prospective Process Validation
- USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL
- Installation Qualification for Pass Box
- Operational Qualification for Pass Box
- DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS)
- PERFORMANCE QUALIFICATION PROTOCOL
- Design Qualification of Pre-treatment & Purified Water Generation System
