Good Distribution Practice and Supply Chain Risk Evaluation

Good Distribution Practice and Supply Chain Risk Evaluation

Who we are - Exelsius An international consultancy established in 2007 bringing cross-sector expertise and skills into a range of services designed to support the implementation of Good Distribution Practice in the Life Sciences and Pharmaceutical Logistics Sector

Successfully Introducing Biosimilars to Market Choose Wisely Choosing the right market is the first step. Consider the most prevalent and costly diseases to treat with the biggest impact Access Markets Focus on innovative market access and financing approaches Distribute Safely Create effective transportations solutions in partnership with proven suppliers. Look for long-term distribution strategies to ensure clients are supplied

Safe Distribution is Your Responsibility CSafe Incheon Workshop Safe Distribution is Your responsibility Distribute Safely Create effective transportations solutions in partnership with proven suppliers. Look for long-term distribution strategies to ensure clients are supplied Good Distribution Practice (GDP): that part of quality assurance which ensures products are consistently stored, handled and transported under suitable conditions as required by the marketing authorization or product specification

Good Distribution Practice Guidance Global Sources of GDP Guidance EU343/01 Effective since 2014 USP 1079 (and upcoming USP1083) IATA TCR for air cargo WHO 957

European Economic Commission (EEC) - DIRECTIVE 94/C63/03 Guidelines on GDP for Human Use (Wholesalers) European Economic Commission - DIRECTIVE 2001/83/EC Community Code Medicinal Products for Human Use U.S. Army Packing Protocols for 2-8C TSMP There are a number of guidance documents Australia Therapeutic Goods Administration Code of Good Warehousing Practice US FDA 21 CFR211.142 & 211.150 Warehousing Procedures & Distribution Procedures Italy Ministero Della Sanita Guidelines on GDP for Human Use World Health Organization TRS 937, Annex 5 GDP Irish Medicines Board Guide to Control and Monitoring of Storage & Transport PDA Technical Report No.46 for Medicinal Products Last Mile GDP to the End User International Conference on Harmonization (ICH) QA1 (R2) or CPMP/ICH/2736/99 Stability Testing of New Drug Substances and Products Brazil Australia Vaccine Storage USP General Chapter <1079> Good Storage & Shipping Practices Canada Health Canada GUI 0069 Guidelines for Temperature Control of Drug Product during Storage & Transport Singapore & ASEAN Member Countries Health Science Authority Guidance Notes on Good Distribution Practices International Air Transport Association (IATA) PCR Chapter 17 - Air Transport Logistics for Time & Temperature- Sensitive Healthcare Products India Israel CPMP/GWP/609/96/Rev2 EMEA Guideline on the Declaration of Storage Conditions MHRA Chapters 6 & 7 EU Guidance on Wholesale Distr. Practices PDA Technical Report No. 39 Guidance for Temperature Controlled Medicinal Products Romania Czech Republic Egypt World Health Organization Model requirements for the storage and transport of time and temperature sensitive pharmaceutical products Malaysia Argentina Saudi Arabia PIC/s, GDP IATA EEC USP MHRA EU API

There is a clear message from GDP regulators Thermal protection of temperature-sensitive medicines is essential throughout the distribution process Manufacturers and suppliers must pre-evaluate their transportation routes and audit their supply chain partners before use Contracted supply chain activities require a quality/service level agreement to be in place Quality Management Systems and preventive measures are to protect product quality in the total supply chain

What you cannot do with GDP Regulations You have a duty of compliance!

Overall GDP Responsibility rests with the Manufacturer EU Guidance Manufacturers Wholesalers Brokers Logistics Service providers Distributors, Equipment Responsibilities Duties

GDP is all about Risk! GDP is about Risk - a Calculation of Hazard and Probability

Risk Identification Knowing Key Risk Points means knowing where to Act Manufacturers & Shippers Product/Package pre-conditioning Product Loading Origin Forwarders & Trucking Co s. Solution Providers Ground Transportation Airport Ground Handlers Warehousing Origin-Destination Air Carrier Tarmac/Apron Areas Aircraft Cargo Hold Airport Ground Handlers Destination Forwarders & Trucking Co s Product Unloading Distributors & Consignees Ground Transportation Final Distribution 2016 EXELSIUS CONSULTANCY

As Globalized Production Grows, so Does Risk Longer supply chains Seasonal temperature variations More use of indirect logistics Infrastructure weaknesses Transportation has become an integral and tightly controlled part of the manufacturing process

A Totally Controlled Environment does not exist! Manufacturing, storage and packing Trucking Distribution handling & loading Storage, handling & loading Trucking Controlled Processes & Environment Uncontrolled Processes & Environment Controlled Processes & Environment

Question what is the likely temperature inside a Regular air cargo container exposed to +20ºC sunlight for 2 hours on an airport ramp? 1. 26C / 78.8F 2. 36C / 96.8F 3. 46C / 114.8F 4. 56C / 132.8F 5. 66C / 150.8F 6. 76C / 168.8F 7. 86C / 186.8F 8. 96C / 204.8F 76C / 168.8F

Protecting Your Product Protection during Transport is a GDP Requirement Active Containers Passive Packaging But so too is evaluating your supply chain partners

Transportation doesn t happen in a laboratory and routes should be Qualified to assess risk Design Qualification (DQ) Operational Qualification (OQ) Performance Qualification (PQ) Transport Qualification

Outsourced Activities through Suppliers Present A Risk CSafe Incheon Workshop The word Risk is repeated: 27 times in the 10 chapters of the new EU GDP Guidelines 19 times in the WHO 957 document

Assessing Risk and Supply Chain Partners GDP Risk Assessment Tool Developed by Exelsius for CSafe Customers

The Tool Allows a Risk Evaluation of Every Step Master Table

First Stage The first stage identifies individual process steps, timings and the process owner, allowing an endto-end analysis to be created.

Next stage identifies key compliance requirements of suppliers

Risk Assessment Third stage assess the risk levels of each process step, against a risk level calculation

Outsourced Activities are a key area of Risk Key Elements Contract giver is responsible for activities contracted OUT through: Audits GDP risk assessments Contract acceptor accountable for activities IN and must have adequate premises, expertise, procedures etc. to carry out the work Extends to any third party supplier/vendor Must have pre-assessed a supplier before any activity

The importance of Written Agreements Any activity covered by GDP that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. There must be a written Contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party EU GDP Guidelines 2013/C 343/01

Quality Agreements Three Important W s Why do you need a Quality Agreement? When is a Quality Agreement needed? Who should prepare the Quality Agreement?

Service Level/Quality Agreements A contract between a (logistics) service provider and its client(s). Specifies what agreed level of service will be provided, how performance may be measured and any delivery specifications. Deals with how exceptions and changes are managed. When used effectively, can be a significant communication tool that allows for performance improvements and also prevents conflicts.

Making SLA s work with your customers/suppliers 7.Impleme nt & Manage 1.Review needs and capabilities The value of an SLA can come from the initial discussion and mutual understanding it brings. 6.Get Ready 2.Agree the agreement Create regular day-to-day communication lines between stakeholders and use them. 5.Get buyin 3.Agree the Ground Rules Give feedback. 4.Develop a draft SLA Be realistic about expectations; measure progress & share it.

Service Characteristics and Management of Agreements Service Responsibilities Terms of business/trading conditions Transportation service standards Contact list and contingency plans Management Management Quality Management Systems Quality audits processes Performance management (e.g. KPI s) Revision methods

Make Performance Measurement Meaningful Align key performance measurements of your vendor(s) to the specific requirements of your product(s) and that of the prevailing regulatory requirements, e.g. : Temperature Management performance Pick-up and delivery performance Equipment, premises and procedures Measure the few, not the many Beware of quality fade Incorporate audits and assessment schedules into the service level agreement

Safe Distribution is Your Responsibility CSafe Incheon Workshop Supply Chain Risk Evaluation Distribute Safely Create effective transportations solutions in partnership with proven suppliers. Look for long-term distribution strategies to ensure clients are supplied Identify Stages Assess Compliance Calculate Risk Mitigate Risk

IQPC London 30 January 2016