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New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Sterile Medicinal Products In-house Training

A comprehensive 3 day course

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

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Overview

The long-anticipated update to EU GMP Annex 1 was published in August 2022 and came into force on 25 August 2023 - marking the first revision in 14 years. This updated guidance introduces new requirements while clarifying and expanding on the 2008 version, with a focus on harmonisation with global standards.

This course provides a comprehensive overview of the changes introduced in Annex 1 and what they mean for aseptic operations. Participants will explore current expectations for sterile manufacturing environments, personnel, equipment, and robust production technologies. Core topics include contamination control, microbiology, sterility assurance, and quality risk management - all presented with real-world examples to support understanding and application.

Key areas such as environmental monitoring, cleaning and disinfection, CCS (Contamination Control Strategy), cleanroom design, RABS, isolators, and advanced technologies like BFS and FFS are all addressed. The course also outlines regulatory expectations from authorities including the FDA, MHRA, TGA, WHO, and PIC/S, with common deviations and practical recommendations discussed.
Ideal for professionals involved in sterile manufacturing, this training offers the insight and guidance needed to meet the latest regulatory standards and maintain GMP compliance with confidence.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

Learn about the regulatory requirements of the revised Annex 1, its impact on aseptic production, terminal sterilisation expectations, and quality challenges
Discover practical tips for overcoming common difficulties still faced in Annex 1 implementation, including solution proposals for an effective Contamination Control Strategy (CCS)
Explore real-world experiences and insights from colleagues and health authority inspectors applying Annex 1 in practice
Hear expert recommendations on key topics such as environmental monitoring, cleaning, disinfection, and hygiene standards for personnel and facilities
Gain valuable knowledge of barrier separation technologies, alternative production methods, and the regulatory requirements for processing different sterile products
Evaluate the integration of automation within GMP-compliant production environments
Receive suggestions for analysing trends observed in aseptic manufacturing and identifying potential areas for improvement
Understand the current and future focus areas of health authority inspections, and how to align operations with regulatory expectations
Examine Annex 1’s requirements for personnel qualification, training, and the essential skills needed for aseptic operations

Who Should Attend

Personnel in the following roles and departments:

Quality Assurance and Quality Control Validation
R & D
Audit
Regulatory
IT
Warehouse and supply chain
Engineering
Procurement
Health Authority Inspectors

This course will cover:

Aseptic Processing Guidelines and Regulations

EU, PIC/S GMP Annex:1
FDA sterile drug products produced by aseptic processing - current Good Manufacturing Practice (GMP)
WHO, MHRA, TGA, PMDA Guidelines

Aseptic Facility Design Principles

Facility types
Equipment impact on facility design
Process impact on facility design
System impact on facility design

Quality Assessment and Mitigation in Aseptic Operations

Sterility, probability, acceptability
Risk mitigation

Risk Management Application Examples

Failure Mode Effects Analysis (FMEA)
Hazard Analysis and Critical Control Point (HACCP)
Process Hazard Analysis (PHA)
Failure Tree Analysis (FTA)
Example: Sterile Product Filling and Finished Product

Microbiology Fundamentals

Microbiological culture media
Microbiology laboratory techniques
Objectionable microorganisms
Rapid microbiological methods
Microbiological challenges

Environmental Monitoring

Why is environmental monitoring (EM) performed?
Types of environmental monitoring
Precautions when conducting environmental monitoring
Trending of EM data
Example: Environmental monitoring investigation study

Bioburden Control & Sterility Assurance

Sterility testing
Bioburden determination

Workshop 1

A: How do you support GMP documentation for purchased disinfectants or sporicides?
B: What test methods do you use for efficacy testing? Do they align with regulatory expectations?
C: What do we mean when we talk about Continuous Improvement?

Recap of Day Two

Cleaning, Disinfection, Sanitation, Decontamination

Example: Wiping mopping strategies
Example: Disinfectant qualification

Can CCS be Acheived via Cleaning and Disinfection?

Sterilization

What is the difference between sterilization and sanitization
Types of sterilization processes
Pre-Use Post Sterilization Integrity Testing (PUBSIT) issues
Example: How to validate the dry heat sterilization process?

Visual Inspection

Manual inspection
Semi-automated inspection
Automated inspection

Critical Utilities

Water systems
Pure steam
Process gases
HVAC

Cleanroom Design and Operation, Airlock Concept

Design specifications
Basic & concept design
Modular and flexible cleanrooms
Typical design mistakes
Airlock concept (PAL, MAL)

BFS, FFS

BFS equipment
Product design
Equipment design
Facility design
Qualification consideration
Product contamination
Example: Do you have a defect library?

High Efficiency Particulate Air (HEPA) Filters

Workshop 2

A: What happens if a positive culture results after processing the Biological Indicators (BI) in a validated steam sterilization cycle?
B: Data integrity considerations in Bacterial Endotoxin Test

RABS & Isolator Technology

Isolators for Personnel and Environmental Protection
Closed RABS
Cytotoxic Drug Preparation Isolator
Aseptic Transfer Systems (Liquid/Solid)
Decontamination of Aseptically Operated Isolators
Monitoring of the Process Environment
Barrier System Flaws
Validation

Contamination Control Strategy

CCS plan, do, check, act
Supplementary documents
Example: What type of documents should be included in a CCS?
Example: Methods for contamination detection

Microbial Contamination Investigation Errors

What is wrong thinking?
Extraordinary Environmental Monitoring
Case studies

How to Prevent Residue, Rouge and Fibers

Facility appearance
Residue, rogue, and rust remediation/prevention
How to manage the risk of reusables in the Aseptic Processing Area

Aseptic Process Simulation (APS)

What is an APS?
What is the purpose?
What are the limitations?
APS dos and don’ts
APS duration
APS interventions
APS incubation
APS Out of Specification (OOS) Investigation

Personnel Behaviour, Qualification, Aseptic Gowning Techniques

Why are personnel important?
Holistic Operator Behaviour and Qualification Program
Potential sources of particulates and gowning measures
Considerations when defining gowning
How to prepare a User Requirement Specification (URS) for aseptic garments
Fabric selection and qualification

Airflow Visualization in Aseptic Manufacturing

What is the purpose of the Airflow Visualization Process?
What do we need for a successful AF Visualization?
Smoke Generation Devices
Video recording - static and dynamic conditions
Documentation and data integrity
How to report an AF operation?

Sterile Product Filling, Stoppering, Sealing

Quality Assurance and Control for Aseptic Operations

Workshop 3

How to validate contamination control in Rapid Transfer Port Chambers

Regulatory Considerations for Aseptic Processing

Audit and inspection findings

Mustafa Edik

Mustafa Edik is an Independent GMP Consultant and Auditor.

After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.

He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.

While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.

He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.

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