GMP Boot Camp

Principles and Practice of Good Manufacturing Practice (GMP)

A two-day workshop presented by Dr. David Inglis, of Ulverston GMP Consulting Ltd and GMP Training Systems, Inc.
Click here for scheduling information.

Day 1

1. Introduction - What is GMP?

• Who is responsible for quality?
• Fundamentals of GMP
• EU definition
• Five "Ps" of GMP
• 21CFR and EU GMP articles/guidelines

2. History and Legal Status of GMP in UK, EU and USA

• Regulatory framework
• Registration and Licenses
• The role of the Qualified Person within EU GMP

3. GMP and Quality Systems

• Organisational structure of Quality Systems
• Quality Systems in practice
• Planned change

Workshop 1 - Hierarchy of Audits

4. Procedures and Records

• Types of procedures
• Types of records
• Who is included?

5. GMP for Investigational New Products (IMPs) - Part A

• EU Guidelines - Annex 13
• Product Specification File

6. GMP for Production and Engineering

• Production SOPs and Records - what is required?
• Engineering SOPs and Records - what is required?
• Training and Education

7a. GMP for Quality Assurance and Quality Control - QA

• Responsibilities and independence
• Auditing and review
• Trending

7b. GMP for Quality Assurance and Quality Control - QC

• Sampling
• Tablet/unit content and uniformity
• Stability testing (overview)

Case Study 1 (Manufacturing) - Sudden Frequent Non-Conforming Batches

Day 2

8. Wider aspects of GMP

• Validation
• Process Analytical Technology (PAT)
• Computerised systems and electronic records

9. GMP for Warehousing and Distribution

• Responsibilities
• Special considerations
• Cold chain distribution

Workshop 3 - Investigative Pathways during Self Inspections (Scheduled Internal Audits)

10. Cleaning and Decontamination

• Line clearance for products
• MACO for Active substances

11. Stability Trials and Stability Testing

• Objectives of Stability programmes
• International requirements for stability testing (ICH Q1)
• Photostability testing and stress testing
• Container Closure System
• Specification
• Testing Frequency
• Storage Conditions
• Evaluation
• Statements/Labelling

Case Study 2 (Laboratories) - HPLC Assay Frequently Fails Precision of Duplicate Injections

12. When Things go Wrong …

• Deviation and non-conformance handling
• Importance of Corrective and preventive Action (CAPA)
• Structured Failure Investigation and CAPA (overview)

Workshop 4 - Elements of a CAPA System (+ Handout)

13. Special Categories (Overview)

• Sterile Products
• GMP within Biotech
• Herbal products

14. Examples of Regulatory Observations and Warning Letters

• "Management with executive responsibility had not …"
• Examples of EU deficiencies
• Examples of warning letters (FDA)