Good Manufacturing Practices (Gmp) & Gmp Audits

Explore Good Manufacturing Practices (GMP) and practice 250 audit questionare for full confidence !

What you'll learn

Understand and define main principles of Good Manufacturing Practices (GMP)

Explore and define audit approach in GMP systems

Explore and understand audit type/process in GMP systems

Understand audit approaches and investigate audit question types

Define general scope of quality management/quality assurance in pharmaceutical industry

Understand and define main principles of Good Laboratary Practices (GLP)

Understand and define main principles of Good Hygiene Practices (GHP)

Understand and define main principles of Good Documentation Practices (GDP)

Requirements

Require mobile/tablet/laptop/personal computer with internet

To be student, graduate and/or pharma professional

Description

Good Manufacturing Practices (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. GMP Audit refers to regular visits to evaluate facilities, production and ensure that all activities are in line with current good manufacturing practices (cGMP). Quality Management (QM) is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. COURSE AGENDA 1 Introduction to GMP & GMP AUDITS 2 General Information about GMP Audits 3 Quality System 3.1. Good Manufacturing Practices (GMPs) 3.2. Basic Requirements of Good Manufacturing Practices (GMPs) 3.3. Pharmaceutical Quality System 4 Personnel 4.1. Personnel 4.2. Personnel & Hygiene 5 Premises & Equipments 5.1. General Information about Premises & Equipments 5.2. Premises & Equipments Requirements in Manufacturing Area 5.3. Premises & Equipments Requirements in Storage Area 5.4. Premises & Equipments Requirements in Quality Control 5.5. Equipment 6 Documentation 6.1. General Information about Documentation 6.2. Specification 6.3. Manufacturing Documentation 7 Production 7.1. General Information about Production 7.2. Contamination, Cross Contamination, Mix-up 7.3. Cross-Contamination 8 Quality Control 8.1. General Information8.2. Good Laboratory Practices 9 Quality Assurance 9.1. Product Quality Review (PQR) 9.2. Complaints 9.3. Change Management 9.4. Deviation 9.5. Corrective Action & Preventive Action 10 Additional Audit Questionare 11 Conclusion

Overview

Section 1: Giriş

Lecture 1 Introduction

Section 2: GMP : GMP Audits

Lecture 2 GMP : GMP Audits

Section 3: Quality System

Lecture 3 Good Manufacturing Practices (GMP)

Lecture 4 Basic Requirements of Good Manufacturing Practices (GMP)

Lecture 5 Pharmaceutical Quality System

Section 4: Personnel

Lecture 6 Personnel in GMP

Lecture 7 Personnel Hygiene

Section 5: Premises and Equipments

Lecture 8 Premises and Equipments General ınformation

Lecture 9 Premises and Equipments in Manufacturing Area

Lecture 10 Premises and Equipments in Storage Area

Lecture 11 Premises and Equipments in Quality Control

Lecture 12 Equipment Requirements

Section 6: Documentation

Lecture 13 Documentation

Lecture 14 Specifications

Lecture 15 Batch Manufacturing Record (BMR)

Section 7: Production

Lecture 16 Production

Lecture 17 Contamination, Cross-Contamination and Mix-up

Lecture 18 Cross-contamination

Section 8: Quality Control

Lecture 19 Quality Control Laboratory

Lecture 20 Good Laboratory Practices

Section 9: Quality Assurance

Lecture 21 Product Quality Review (PQR)

Lecture 22 Complaints

Lecture 23 Change Management

Lecture 24 Deviation

Lecture 25 Corrective Action and Preventive Action (CAPA)

Section 10: Conclusion

Lecture 26 Conclusion

Learners who desire to take a part in Quality, Production and Research&Development Departments in Pharmaceutical Industry,Anyone who is looking to learn quality and audit approaches in pharmaceutical industry,Anyone who interest GMP certification in pharmaceutical industry,Existing pharma professionals who are looking to progress in their jobs,Anyone who is looking to get entry in pharmaceutical industry