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
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.
This is where Good Distribution Practice (GDP) comes into play. Good Storage and Distribution Practices (GSP, GDP) are paramount throughout the life cycle of pharmaceutical products and Active Pharmaceutical Ingredients (APIs). The pharmaceutical product network, as we know, is complex and involves multiple parties, compounded by increasing criminal activity introducing counterfeit drugs into the legal supply chain. European guidance emphasizes quality systems, risk management principles, and delineates clear responsibilities and processes. It is now inevitable for pharmaceutical distributors to establish a quality system by defining responsibilities, processes, and risk management principles related to their activities.
Given the distances medicinal products must travel and various external factors they may encounter post-production, licensed companies aim to ensure their products reach patients without spoilage or falsification. The primary objective of this training course is to offer a comprehensive perspective on who should implement these practices and when, along with discussing mechanisms to demonstrate the maintenance of quality, integrity, potency, and identity of the finished drug product from raw material to the supply chain's end.
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. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
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
- Responsible Persons
- Quality Assurance/Quality Control Specialists
- Regulatory Affairs Professionals
- Engineering Officers
- Supply Chain Personnel
- Logistics Personnel
- Warehouse & Distribution Professionals
- Compliance Officers
- Any pharmaceutical professionals involved in the storage and distribution of pharmaceutical products and APIs
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 & 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
- Placing 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 & 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 & Good Documentation Practices
- Data Integrity for temperature-controlled pharmaceuticals
Supplier & 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 an Independent GMP Consultant and Auditor.
After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
