ISO 22716 Lead Auditor Training - Philippines

ISO 22716 Lead Auditor Training Course Outline

Module 1: Introduction to ISO 22716

• Introduction
• Scope
• Terms and Definitions

Module 2: Good Manufacturing Practices (GMP)

• What is GMP?
• Components of GMP
• GMP Principles
• Regulations and Standards
• How to Comply with Guidelines?

Module 3: Personnel

• Principle
• Organisation
• Key Responsibilities
• Training
• Personnel Hygiene and Health
• Visitors and Untrained Personnel

Module 4: Premises

• Principle
• Types of Area
• Space
• Flow
• Floors, Walls, Ceilings, Windows
• Washing and Toilet Facilities
• Lighting
• Ventilation
• Pipework, Drains, and Ducts
• Cleaning and Sanitisation
• Maintenance
• Consumables
• Pest Control

Module 5: Equipment

• Principle
• Equipment Design
• Installation
• Calibration
• Cleaning and Sanitisation
• Maintenance
• Consumables
• Authorisations
• Back-Up Systems

Module 6: Raw Materials and Packaging Materials

• Principle
• Purchasing
• Receipt
• Identification and Status
• Release
• Storage
• Re-Evaluation
• Quality of Water Used in Production

Module 7: Production

• Principle
• Manufacturing Operations
• Packaging Operations

Module 8: Finished Products

• Principle
• Release
• Storage
• Shipment
• Returns

Module 9: Introduction to Internal Auditor

• Who is Internal Auditor?
• Duties of Internal Auditor
• Soft and Hard Skills for Internal Auditor
• Internal Vs External Auditor

Module 10: Internal audit

• Principle
• Approach
• Follow-Up

Module 11: GMP Audit

• What is GMP Audit?
• What is Involved in the GMP Audit Process?
• How to Prepare for a Typical GMP Audit?
• Hosting GMP Audit
• Common Mistakes Made During GMP Audits
• GMP Auditing Best Practices

Module 12: GMP Supplier Audit

• Conducting a GMP Supplier Audit
• Supplier Audit Checklist
  • Quality Policy
  • Training and Accountability
  • General Organisation
  • Supply Access
• Steps to Successfully Perform the GMP Supplier Audit

Module 13: Quality Control Laboratory

• Principle
• Test Methods
• Acceptance Criteria
• Results
• Out-of-Specification Results
• Reagents, Solutions, Reference Standards, Culture Media
• Sampling
• Retain Sample

Module 14: Treatment of Product

• Rejected Finished Products, Bulk Products, Raw Materials, and Packaging Materials
• Reprocessed Finished Products and Bulk Products

Module 15: Wastes

• Principle
• Types of Waste
• Flow
• Containers
• Disposal

Module 16: Subcontracting

• Principle
• Types of Subcontracting
• Contract Giver
• Contract Acceptor
• Contract

Module 17: Implementing GMP

• Quality Management
• Sanitation and Hygiene
• Building and Facilitation
• Equipment
• Raw Materials
• Personnel
• Validation and Qualification
• Complaints
• Documentation and Recordkeeping

Module 18: Lead Auditor

• Who is the Lead Auditor?
• Roles and responsibilities of Lead Auditor
• Audit Report
• Types of Audit Process

Module 19: Deviations

• Deviations Overview

Module 20: Complaints and Recalls

• Principle
• Product Complaints
• Product Recalls

Module 21: Change Control

• Change Control Overview

Module 22: Structured GMP Audit

• Customer Communication
• Auditor Selection
• Auditor Planning
• Audit Preparation
• Audit Execution
• Audit Report

Module 23: Documentation

• Principle
• Type of Document
• Writing, Approval, and Distribution
• Revision
• Archiving