Course overview
It is crucial that pharmaceutical products adhere not only to high-quality standards as per Good Manufacturing Practice but also maintain their quality and integrity throughout the entire supply chain, up to the patient.
In today's pharmaceutical landscape, ensuring the safe and reliable distribution of medicinal products is more critical than ever. The complexities of the pharmaceutical supply chain, coupled with the rising threat of counterfeit drugs infiltrating legitimate channels, underscore the necessity for robust Good Distribution Practice (GDP) standards. Good Storage and Distribution Practices (GSP, GDP) are paramount throughout the life cycle of pharmaceutical products and Active Pharmaceutical Ingredients (APIs).
European regulations state the importance of implementing quality systems, risk management principles, and clearly defined processes to safeguard pharmaceutical integrity. Pharmaceutical distributors must establish comprehensive quality systems that define roles, processes, and risk management strategies to mitigate these challenges effectively.
This training course addresses the imperative for pharmaceutical distributors to adhere to GDP guidelines meticulously. Participants will gain thorough understanding of the roles responsible for implementing these practices and the critical junctures within the supply chain where they are most crucial. Discussions will focus on practical strategies for maintaining the quality, potency, integrity, and identity of pharmaceutical products from raw materials through to final distribution, ensuring compliance and safeguarding patient safety.
CPD Hours: 12
Course Content
- Day 1
- Introduction to GDP and supply chain
- Drug shortages and counterfeiting
- Storage of pharmaceuticals and biologics
- Temperature mapping study
- Group exercise 1: Risk assessment application to the pharmaceutical supply chain
- Workshop: Risk assessment
- Group exercise 2: Temperature risk management
- Day 2
- Active and passive systems
- Lane qualification & cargo security considerations
- GDP for pharmaceuticals
- GDP for Active Pharmaceutical Ingredients (APIs)
- Data integrity and Good Documentation Practices
- Supplier and customer qualification
- Regulatory inspections and cases
- Group exercise 1: Truck qualification plan
- Group exercise 2: How to switch from air to ocean transport
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.
