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 Lead Auditor?
- Roles and responsibilities of Lead Auditor
- Audit Report
- Types of Audit Process
Module 19: Deviations
Module 20: Complaints and Recalls
- Principle
- Product Complaints
- Product Recalls
Module 21: Change Control
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