ISO 22716 Lead Auditor Training

The ISO 22716 Lead Auditor Course offers in-depth training on conducting audits based on the ISO 22716 standard for Good Manufacturing Practices in the cosmetics industry. Designed for professionals seeking to lead audits internally or on behalf of third parties, this course develops the skills to verify GMP compliance and support continuous improvement in manufacturing practices.

Key Topics Covered

• ISO 22716 Framework: Understand the scope, terminology, and regulatory context of GMP
• GMP Implementation: Explore controls related to personnel, premises, equipment, and production
• Internal and Supplier Audits: Learn the full audit cycle from planning to reporting
• Quality and Documentation: Review procedures for change control, recalls, waste, and subcontracting
• Lead Auditor Skills: Gain the tools to plan, conduct, and report GMP audits

Course Benefits

• Master GMP Auditing: Learn how to lead comprehensive audits in accordance with ISO 22716
• Support Product Safety and Compliance: Help your organisation meet regulatory and customer requirements
• Lead Supplier Evaluations: Strengthen supply chain integrity through qualified audit procedures
• Drive Continuous Improvement: Identify nonconformities and recommend corrective actions
• Boost Your Career: Build valuable lead auditor credentials for roles in quality, regulatory, and manufacturing operations

This course is ideal for professionals who want to lead or participate in audits within GMP-regulated industries, especially cosmetics and personal care. Suitable roles include:

• Quality Assurance Managers
• GMP Compliance Officers
• Internal and Supplier Auditors
• Manufacturing and Production Supervisors
• Regulatory Affairs Professionals
• Safety and Hygiene Managers
• Consultants and Certification Auditors

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 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

By the end of the course, you will be able to:

• Describe the requirements and principles of ISO 22716
• Plan, conduct, and report on GMP audits in manufacturing environments
• Assess compliance in personnel hygiene, facility management, and product quality
• Lead supplier audits and evaluate documentation practices
• Contribute to GMP implementation and quality assurance processes

To achieve the ISO 22716 Lead Auditor Training, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice 

• Total Questions: 30 

• Total Marks: 30 Marks 

• Pass Mark: 50%, or 15/30 Marks 

• Duration: 40 Minutes