Course overview
Adhering to Good Distribution Practices (GDP) and Good Storage Practices (GSP) is essential to ensure that pharmaceutical products reach patients and healthcare providers in optimal condition, thereby safeguarding patient health and maintaining compliance with regulatory standards. In the pharmaceutical industry, it is as crucial to store, transport, and distribute products in a manner that preserves their quality and integrity as it is to manufacture them.
This training is designed to provide you with a comprehensive understanding of GDP and GSP principles and best practices. You will learn the key aspects of distribution and storage systems, including temperature control, traceability, documentation, and risk management, to ensure compliance with international regulations (such as those set by the FDA, WHO, and the EU) and industry standards.
By the end of this training, you will have the practical skills and knowledge to implement robust distribution and storage practices within your organisation. Whether you are managing a warehouse, overseeing logistics, or working in quality assurance, this programme will equip you to ensure that pharmaceutical products are handled and transported in full compliance with GDP and GSP requirements.
CPD Hours: 12
Course Content
- Day 1
- Introduction to good distribution practices (GDP) and good storage practices (GSP)
- Regulatory framework and compliance requirements
- Risk management in distribution and storage
- Good storage practices (GSP) - key principles
- Temperature-controlled distribution systems
- Workshop - how to audit temperature mapping study
- Day 2
- Product traceability and documentation
- Managing the supply chain and third-party logistics
- Handling non-conformities and corrective actions
- Preparing for audits and regulatory inspections
- Building a culture of quality and compliance
- Workshop - how to audit airline cargo companies
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.
