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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 a leading pharmaceutical, biotechnoloy, medical device quality and GXP expert with over 28 years of hands-on leadership in GMP, GDP, GCP, GLP, and broader GxP compliance across the pharmaceutical, biotechnology, and medical device industries.

As Turkey's first IRCA-certificated Lead Auditor for GMP and Pharmaceutical Quality Management Systems (PQMS), he brings unmatched credibility and depth to audits, compliance strategies, and regulatory readiness. Holding a BSc in Chemistry, and a BSc (Hons) in Biopharmaceutical Sciences & Engineering from Atlantic Technological University (Ireland), and an Executive MBA, Mustafa combines strong scientific foundations with strategic business acumen.

His career highlights include senior roles at Bayer Türkiye, where he progressed from Quality Control Lab Supervisor to Deputy QA Manager, and GMP Lead Auditor to Global GMP Lead Auditor, managing complex quality operations and audits in a multinational environment. He has personally led more than 4,200 hours of GxP audits across over 200 facilities worldwide.

Today, as Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık, Mustafa delivers high-impact consulting, training, and project management services to local and global clients. His expertise spans across:

GMP/GDP audits and supplier qualification
Validation, qualification, and quality risk management (ICH Q9)
Root cause analysis, CAPA, OOS/OOT, change control, and data integrity
Sterile/non-sterile manufacturing, process improvement, and cost-of-quality optimisation
Clinical trials (GCP & ICH E6), pharmacovigilance, and third-party manufacturing
Regulatory alignment with FDA, EMA, PIC/S, MHRA, TGA, TMMDA, WHO, and ICH standards

Mustafa has trained over 9,000 professionals in GxP topics and designed certified auditor programs for Turkish authorities including Turkish MOH and Ministry of Agriculture and Foresty. He served as Principal GMP Consultant & Auditor at the Turkish Atomic Energy Authority, supporting successful TMMDA GMP approvals for 5 radiopharmaceutical products. As the first Turkish consultant selected by the Developing Countries Vaccine Manufacturers Network (DCVMN), he has led teams of 100+ engineers, auditors, and quality specialists while managing dozens of international projects.

A prolific author, Mustafa's works include:

“Sorularla GMP Dokümantasyonu” – a practical guide to GMP documentation
“GMP Audits in Pharmaceutical and Biotechnology Industries” (Taylor & Francis / CRC Press, June 2024) – a comprehensive reference on effective GMP auditing practices

Recognised internationally for his practical, risk-based approach and knowledge transfer focus, Mustafa Edik is dedicated to elevating pharmaceutical quality standards, helping companies achieve compliance excellence, reduce risks, and drive operational efficiency.

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