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.
CPD Hours: 18
Course Content
- Day 1
- Aseptic Processing Guidelines and Regulations
- Aseptic Facility Design Principles
- Quality Assessment and Mitigation in Aseptic Operations
- Risk Management Application Examples
- Microbiology Fundamentals
- Environmental Monitoring
- Bioburden Control & Sterility Assurance
- Workshop 1
- Day 2
- Recap of Day Two
- Cleaning, Disinfection, Sanitation, Decontamination
- Can CCS be Acheived via Cleaning and Disinfection?
- Sterilization
- Visual Inspection
- Critical Utilities
- Cleanroom Design and Operation, Airlock Concept
- BFS, FFS
- High Efficiency Particulate Air (HEPA) Filters
- Workshop 2
- RABS & Isolator Technology
- Day 3
- Contamination Control Strategy
- Microbial Contamination Investigation Errors
- How to Prevent Residue, Rouge and Fibers
- Aseptic Process Simulation (APS)
- Personnel Behaviour, Qualification, Aseptic Gowning Techniques
- Airflow Visualization in Aseptic Manufacturing
- Sterile Product Filling, Stoppering, Sealing
- Quality Assurance and Control for Aseptic Operations
- Workshop 3
- Regulatory Considerations for Aseptic Processing
Speakers
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.
