Quality Assurance

Post by: Suresh Motukuri
July 13, 2022
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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

Suresh Motukuri

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