Follow
Chapter 1: Quality Management
– Principles
– Quality Assurance
– Good Manufacturing Practice
– Quality Control
– Audits
– Quality Evaluation Audits
– Critical Procedures
Chapter 2: Organisation and Personnel
– Principles
– Responsibilities of Key Personnel
– Legal Aspects
– Qualifications
– Training
– Hygiene
Chapter 3: Premises and Equipment
– Principles
– Premises
– Equipment
Chapter 4: Materials Management
– Principles
– Purchasing
– Receiving
– Storage
– Issuing
Chapter 5: Manufacturing
– Principle
– Validation
– Dispensing
– Manufacturing Operations
– In-process Control
– Contamination
– Reprocessing
Chapter 6: Packaging
– Principles
– Component Issue
– Packaging Operations
– In-process Control
– Contamination
– Finished Product Release
Chapter 7: Quality Control
– Principles
– Responsibilities
– Equipment
– Personnel
– Sampling
– Testing
– Standards, reagents
– Documentation
– Stability
Chapter 8: Documentation
– Principles
– Preparation, Issue and Use of Documents
– Master Specifications
– Master Manufacturing Instructions
– Master Packaging Instructions
– Batch Records (Starting Materials)
– Batch Records (Packaging Materials)
– Batch Records (Manufacturing)
– Batch Records (Packaging)
– Other Procedures and Records
– Analytical Records
– Other Documentation Required
Chapter 9: Validation
– Principles
– Validation Master Plan
– Validation Protocol
– Validation Report
– Qualification
– Process Validation
– Analytical Method Validation
– Cleaning Validation
– Computer System Validation
– Validation of specific dosage forms
Chapter 10: Returned Goods
– Principle
– Procedures
Chapter 11: Complaints, Adverse Events, Recalls & Withdrawals
– Principles
– Complaints
– Adverse Events
– Recalls
Chapter 12: Contract Manufacture, Analysis and Servicing
– Principles
– Manufacture And/Or Packaging
– Contract Analysis
– Service Contracts
Chapter 13: Veterinary Medicines
– Principles
– General Requirements
– Special Requirement
Chapter 14: Radio pharmaceuticals
– Principles
– Registration Requirements
– Personnel
– Premises and Equipment
– Production and Handling of Radioactive Preparations
– Quality Control
– Packaging of Radio pharmaceuticals
– Non-radioactive Kits
– Distribution and Recalls
Chapter 15: Biological Medicines
– Principles
– Personnel
– Premises and Equipment
– Animal Quarters and Care
– Documentation
– The Possibility of Contamination
– The Possibility of Infection
– Where the Product Itself is an Infectious Agent
– Starting Materials
– Seed Lot and Cell Bank System
– Operating Principles
– Quality Control
– Special Requirements for Final Testing
– Waste Disposal
Chapter 16: Homeopathic Medicines
– Principles
– Premises
– Documentation
Chapter 17: Medical Gases
– Principle
– General Requirements
– Pipelines
– Filling Areas
– Preparation of Returned Cylinders
– Filling
– Lot Identification
– Release
– Storage
Chapter 18: Good Pharmaceutical Wholesaling Practice
– Principles
– General Requirements
– Storage
– Transport
– Documentation and Control
Chapter 19: Electronic Data Processing
– Principles
– Responsibilities
– Validation
– Security
Chapter 20: Security Guidelines
– Principle
– Security Personnel
– Entry to Site
– Entry to Buildings
– Internal Security
Chapter 21: Safety and Environmental Protection
– Principles
– Safety
– Environmental Procedures
Chapter 22: Sterile Products
– Introduction
– Definitions
– Facilities
– Air Handling Systems
– Sanitisation and Monitoring
– Personnel Training
– Manufacturing Requirements and Controls
– Validation of Aseptic Process
– Sterilisation Processes
– Quality Control
– Finishing of Sterile Products
– Batch Release
Chapter 23: Isolator Technology
– Principles
– Definition of Terms
– Isolator Design Principles
– The Siting of Isolators
– Factory Acceptance Test (FAT)
– Installation Qualification (IQ)
– Operational Qualification (OQ)
– Process Qualification (PQ)
– Microbiological Monitoring
– Sanitisation of Materials
– Gas Sterilisation of Isolator Systems
Chapter 24: Aerosols & Metered Dose Inhalers
– Principles
– General
– Premises & Equipment
– Production & Quality Control
