Presented by
Management Forum
Good Distribution Practices of Pharmaceuticals and APIs In-house Training
Navigating Supply Chains: Elevate Your Expertise in Good Distribution Practices for Pharmaceuticals and APIs. Ensure Compliance and Quality Assurance
Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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.
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
- Gain comprehensive understanding of international GDP guidelines and regulations
- Explore supply chain risks and effective mitigation strategies
- Identify causes and explore solutions for drug shortages
- Acquire knowledge on cargo security protocols
- Receive expert guidance on detecting and preventing counterfeit drugs in the supply chain
- Learn storage and transportation requirements for pharmaceutical products in alignment with current pharmacopoeias
- Understand risks associated with transporting temperature-sensitive pharmaceuticals
- Obtain detailed insights into equipment qualification for storage, transport, and distribution
Who should attend?
Pharmaceutical personnel involved in the distribution of pharmaceuticals and APIs, including:
- Responsible persons
- Quality assurance specialists
- Quality control officers
- Regulatory affairs professionals
- Engineers
- Supply chain managers
- Logistics coordinators
- Warehouse and distribution managers
- Contracted warehouse and distribution centre operators
This course will cover:
Introduction to GDP and supply chain
- What is GDP, GSP?
- Regulatory Guidelines
- GDP, GSP (EMA, PIC/S, MHRA, TGA, WHO, FDA, EU GMP Annex 11, 15), USP 1079
- Industry
- APIC, IPEC, PDA, IATA, CEIV, ISPE, ASTM,
- Introduction to the pharmaceutical supply chain
- How to determine and mitigate the pharmaceutical supply chain risks?
- What are the main risks available?
- Should disaster recovery be a requirement?
- How to implement contingency planning & business continuity?
Drug shortages and counterfeiting
- How to prevent drug shortages?
- How to detect counterfeiting in legal supply chain?
- How to manage fake medicines e.g. during the Covid-19 pandemic?
Storage of pharmaceuticals and biologics
- What is the optimum storage condition for pharmaceuticals, biologicals?
- How to manage time & temperature sensitive pharmaceutical, biological products?
- What to do when planning to design a cold room?
- How to qualify warehouse and distribution equipment?
- What factors must be taken into consideration to execute a temperature mapping study?
- Developing a Validation Plan
- Considering areas at risk
- Developing a protocol
- Calibration of data loggers
- Studying duration of the mapping
- Determining the measuring range
- Good Documentation Practices
- Collecting Data Loggers
- Downloading data
- Analysing data (21 CFR Part 11, EU GMP Annex 11, GAMP5)
- Preparing mapping report
- How to avoid temperature mapping mistakes?
- Where to locate temperature mapping devices?
- How to handle temperature & humidity excursions?
- What is Mean kinetic Temperature (MKT)?
- Is it necessary for every temperature ranges?
- Is it globally accepted?
- Is humidity a mandatory requirement in warehouses and cold rooms?
- How to choose the best temperature monitoring device?
Temperature mapping study
Group exercise 1: Risk assessment application to the pharmaceutical supply chain
- Critique of format
- Critique of content
Workshop: Risk assessment
- Breakout groups to review and suggest improvement in risk assessment.
Group exercise 2: Temperature risk management
- Critique of format
- Critique of content
Active and passive systems
- How to choose active and passive temperature-controlled systems?
- Do you think that you know much about dry ice?
- Does it make sense to start with a Validation Master Plan?
Lane qualification & cargo security considerations
- What is a route /lane qualification?
- What are the transportation risks?
- How to ensure security on the road?
- How is transport validation different from transport verification?
- What is the main purpose of cloud-based temperature monitoring?
- What are the pros and cons of road, sea, air transport?
- Determining air freight and ocean freight challenges
GDP for pharmaceuticals
- Are they known?
- Are they followed?
- Are they enforced?
GDP for Active Pharmaceutical Ingredients (APIs)
- Interpretation of API GDP requirements
- Responsibilities of involved parties
- What is new for API manufactures?
- Implementation status
- Compliance expectations from API manufacturers
Data integrity and Good Documentation Practices
- Data Integrity for temperature-controlled pharmaceuticals
Supplier and customer qualification
- How to qualify a third-party logistics service provider
- Are you looking for a partner or supplier?
- Selecting the best 3PLSP
- How to audit warehouses and 3PLSPs?
Regulatory inspections and cases
- What do the regulatory inspectors expect to see during an inspection?
Group exercise 1: Truck qualification plan
- Critique of format
- Critique of content
Group exercise 2: How to switch from air to ocean transport
- Critique of format
- Critique of content
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.
Reviews of IPI's Good Distribution Practices of Pharmaceuticals and APIs training course
Very comprehensive and informative course. With a high level of detail and examples given by a very knowledgeable trainer.
Mar 17 2025
Christopher Brend 
Associate Director UK & Ireland Country Quality RP/RPi, Alexion Pharma UK Ltd
United Kingdom
- Alexion Pharma UK Ltd
- Baxter Healthcare Ltd
Algeria
- Pfizer Inc.
Greece
- Adragos Pharma
Lebanon
- International Committee of the Red Cross
Netherlands
- Santen SA/NL
Switzerland
- Lonza Group
Run Good Distribution Practices of Pharmaceuticals and APIs Live online for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our team to discuss your requirements:
