- Common Causes of Low Quality in Pharmaceuticals
- Tips for Preventing and Troubleshooting Manufacturing Deviations
- Steps to Ensure CAPA Success in Pharmaceuticals
- Importance of Qualified Persons in Pharmaceuticals
- Sampling in Cleaning Validation in Pharmaceutical Industry
- Implementation of Six Sigma in the Pharmaceutical Industry
- Types of Purified Water Systems in Pharmaceuticals
- Regulatory Requirements for Market Complaints
- Common Ways to Avoid the Most Frequent GMP Errors
- Code of Federal Regulations (CFR)
- Requirements and Implementation of Continuous Training in Pharmaceuticals
- Gap Analysis for Regulatory Compliance
- Quality by Design (QbD) in Pharmaceuticals
- Role of RH and Temperature in Dry Powder Injection Manufacturing
- Importance of Validation in Pharmaceuticals
- Guidelines for Drug Master File Submission
- Requirements of FDA for Training in Pharmaceuticals
- Requirements for Good Documentation Practice (GDP)
- Periodic Review and Compliance in the Pharmaceutical Industry
- Self Inspection and Its Implementation in Pharmaceuticals
- CAPA and Its Proper Implementation
- Tips to Develop Equipment Cleaning Procedure
- Importance of Corrective and Preventive Action (CAPA)
- Handling Static Charge in Pharmaceutical Manufacturing
- Fishbone Tool of Investigation in Pharmaceuticals
- Possible Causes of Out of Specification
- Top 5 Tips for a FDA Inspection
- Fault Tree Analysis for Investigation
- Criteria to Choose the Correct Swab for Cleaning Validation
- Quality System in Pharmaceuticals
- Quality Inspection in Pharmaceuticals
- Common Technical Document (CTD) for Dossiers
- Role of Regulatory Affairs in Pharmaceuticals
- Causes and Remedies of Picking in Tablet Manufacturing
- Total Quality Management (TQM)
- FDA Warning Letters for Cleaning Validation
- Control of Contamination at Different Manufacturing Stages
- How to Write a Validation Master Plan?
- Difference between Process Validation and Product Validation
- Quality Manual and Quality Policy
- Difference between Generic and Branded Medicines
- Quality Metrics for Pharmaceutical Manufacturing
- Best Communication Skills for Managers
- Different Types of Glass Containers used in Pharmaceuticals
- ALCOA to ALCOA Plus for Data Integrity
- Visual Inspection of Light Sensitive Products
- Difference between Recall and Mock Recall
- How Does Quality Cost Less in Long Term?
- Difference Between Disinfectants and Antiseptics
- What Does Quality Really Mean for Pharmaceuticals?
- Causes and Remedies of Chipping in Tablet Manufacturing
- Vendor Qualification/ Approval Flowchart
- Electronic Batch Records in Pharmaceuticals
- Checklist for BMR Review
- Types of Primary Packaging in Pharmaceuticals
- Preparation of Batch Packaging Record (BPR)
- Validation of Compressed Air
- Site Acceptance Test (SAT)
- Packaging of Pharmaceutical Products
- Checklist for Batch Review in Liquid Manufacturing
- Difference between cGMP and GMP
- Causes and Remedies of Sticking in Tablet Manufacturing
- Difference between Sustained Release and Prolonged Release Tablets
- Causes and Remedies of Cracking in Tablet Manufacturing
- Causes and Remedies of Lamination in Tablet Manufacturing
- Interview Questions for Quality Control / Assurance in Pharmaceuticals
- Causes and Remedies of Capping in Tablet Manufacturing
- Leak Detection of Colored Vials in Pharmaceuticals
- IPQC During Compression Operation
- Difference between Quality Assurance and Quality Control
- Functions of Quality Assurance
- Types and Functionality of Tablet Coating
- In-process Quality Control Procedure
- OOS Investigation Flowchart
- Checklist for OOS Investigation
- Checklist for Vendor Audits
- Quality Management System (QMS)
- Temperature and Humidity Validation/Mapping in Storage Area
- Why Firms Must Avoid FDA 483 and Warning Letters?
- Acceptable Quality Level (AQL) in Pharmaceuticals
- Procedure for Sampling in Process Validation
- Preparation of Master Formula Record (MFR)
- 4 Tips to Reduce 483 Observations
- How to Write a Validation Protocol?
- Transport Validation for Pharmaceutical Products
- Different Mesh Sizes and Mesh to Micron Conversion
- Quality Risk Management in Pharmaceuticals
- Recovery Factor Determination in Cleaning Validation
- Importance of Mixing Time in Blend Uniformity
- Hold Time Study in Pharmaceutical Manufacturing
- Difference between Humidity and Relative Humidity
- Preparation of Batch Manufacturing Record (BMR)
- Risk of TSE and BSE in Pharmaceutical Products
- Fluidized Bed Dryers and FInger Bags
- 5 Why Tool for Root Cause Analysis in Pharmaceuticals
- Preservatives and Their Concentrations used in Liquid Preparations
- Binder Concentration in Tablet Manufacturing
- SOP for Personnel Gowning Qualification
- SOP for Equipment Qualification
- SOP for Failure Investigation
- SOP for Validation of Visual Checking Inspectors
- SOP for Training of Employees
- SOP for Product Registration
- SOP for Entry in Quality Assurance Department
- SOP for Data Integrity
- SOP for Self Inspection and Internal Audits
- SOP for Documentation and Data Control
- Sampling and Testing in Exhibit and Process Validation Batches
- SOP for Password Policy and Data Backup and Storage for Computer Systems
- Revalidation of Pharmaceutical Processes
- Deviation Flowchart
- SOP for Acceptable Quality Level (AQL)
- SOP for Dossier
- Pass boxes in Classified Areas
- Why Companies are Selling Same Drug in Different Prices?
- Design of a Sterile Facility in Pharmaceuticals
- Process Validation Sample Protocol
- Annual Product Quality Review (APQR/APR/PQR) in Quality Improvements
- Organogram and Job Responsibilities in Pharmaceuticals
- Difference between Incidence and Deviation
- Three Consecutive Batches for Validation in Pharmaceuticals
- Checklist for Internal Audit or Self Inspection Defects and Regulatory Compliance
- SOP for Control of Cross-contamination
- Solid Pharmaceutical Dosage Forms – Capsules
- Self Inspection and Quality Audits
- Sterile Pharmaceutical Dosage Forms – Parenteral Preparations
- Oral Liquid Pharmaceutical Dosage Forms
- Preparation of Annual Product Review (APR)
- Performance Qualification of Isolator Systems
- Cleaning Validation Protocol for Sample Container
- Skill Matrix – Evaluation of Training in Pharmaceutical
- Cleaning Validation of Pharmaceutical Equipments
- Difference among Calibration, Validation & Qualification
- Guidelines for Preparation of Site Master File (SMF)
- What is Change Control ?
- GMP Audit Check List- Personnel and Premises
- GMP Audit Check List- Water Supply System
- GMP Audit Check List- Weighing and Dispensing
- GMP Audit Check List- Storage of Starting Materials
- Guidelines for Preparation of VMP (Validation Master Plan)
- Purpose of Process Validation in Pharmaceuticals
- Concept of Revalidation in Pharmaceuticals
- Non-sterile Process Validation in Pharmaceuticals
- Corrective Action and Preventive Action (CAPA)
- SOP for Reprocessing and Reworking
- SOP for Deviation Control
- SOP for Review of BMR
- SOP for Mix-up
- SOP for Product Recall
- SOP for Process Validation
- SOP for Change Control
- SOP for Line Clearance
- SOP for Authorized Signatory
- SOP for Corrective Action and Preventive Action (CAPA)
- SOP for Technology Transfer
- Cleaning Validation of Manufacturing Equipment
- Change Control in Pharmaceuticals
- SOP for Vendor Audit
- Tablet Manufacturing Process Flowchart
- Cleaning Validation Sample Protocol
- GMP Audit Check List- Filling and Packaging
- Qualification of Systems and Equipment in Pharmaceuticals
- Cleaning Validation Protocol for Pharmaceuticals
- GMP Audit Check List- Process Validation
- GMP Audit Check List- Sanitation and Hygiene
- GMP Audit Check List- Equipment
- Prospective Validation
- SOP for Handling of Market Complaints
- SOP for Gowning Procedure for Visitors in Quality Control
- Prevention of Cross – Contamination During Processing
- SOP for Collection and Storage of Retained Samples of Raw Material
- SOP for Preparation, Approval, Issue, Control, Uncontrol and Revision of Quality Manual
- Adverse Reaction of Pharmaceutical Dosages Forms
- Tablet Coating Problems and their Solutions in Pharmaceuticals
- Sugar Coating Process and its Problems in Pharmaceuticals
- SOP for Handling of Market Complaints in Pharmaceuticals
- SOP for Release of Finished Product
- Product Recall Procedure in Pharmaceuticals
- SOP for Control of Master Data Generation by Computer System
- SOP of SOP (SOP on SOP) in Pharmaceuticals
- Procedure for Line Clearance Before Commencing any Manufacturing Operation
- Handling of Out of Calibration Instruments and Equipment
- SOP for Quality Risk Management
- Hold Time Study of Cleaned Equipments
- SOP for Hand Wash Procedure
- SOP for Preparation, Review and Approval of Standard Operating Procedures
- GMP Inspection in Production
- Procedure for Preparation of APR (Annual Product Review)
- SOP for Challenge Test of Solid Flow Monitor in Fluid Bed Dryer
- Facility Qualification in Pharmaceuticals
- Procedure for Qualification of Vendors for Raw Material and Packaging Materials
- SOP on Standard Operating Procedure
- Site Master File (SMF) for Pharmaceuticals
- Product Recall Procedure in Pharmaceutical
- Deviation Control in Pharmaceuticals
- Types and Procedure of Change Control
- Handling of Pharmaceutical Market Complaints
- SOP for Qualification of Facility/Equipments/Systems
- SOP for Bubble Point Test
- SOP for Preparation of Master Formula Record (MFR)
- SOP for Out of Specification (OOS) for Pharmaceutical Results
- SOP for Incident Reporting and Investigation
- SOP for Good Documentation Practices (GDP)
- SOP for Discipline in Manufacturing Area
- SOP for Leak Test of Strip, Blister and Alu – Alu Blister Sealing
- SOP for Line Clearance in Manufacturing Area
- SOP for Destruction of Control Samples (Raw Material and Finished Product)
- SOP for Trend Analysis
- SOP for Sampling and Release of Inprocess Samples
- SOP for Sampling of Finished Product

Quality Assurance
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Suresh Motukuri
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