SOP
- 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 and Control of Specifications and Standard Test Procedures for Raw Materials, Packaging Materials, In-process Materials and Finished Products
- 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 Control Quiz 1
- Quality Risk Management -Questions and answers
- Quality Control -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)
- 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
- 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
- Preparation, Approval and Control of Specifications and Standard Test Procedures for Raw Materials, Packaging Materials, In-process Materials and Finished Products
- Quality Control Quiz 1
- Quality Control -Questions and answers
- 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
- GMP Inspection HPLC Checklist
- Water Analysis as per IP/BP/USP
- HPLC Chromatography 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 Chromatography
- 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
