<1079> Good Storage and Distribution Practices

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2 <1079> Good Storage and Distribution Practices Desmond Hunt, Ph.D. Principal Scientific Liaison September 7, 2017 Mexico City, Mexico

Good Distribution Practice Activities Suppliers Procuring, holding, storing, selling, importing, exporting, or movement of pharmaceutical materials or products The Goal To maintain the integrity of

3 Good Distribution Practice Activities Suppliers Procuring, holding, storing, selling, importing, exporting, or movement of pharmaceutical materials or products The Goal To maintain the integrity of drug products throughout the supply chain To ensure drug products reach the end user with their safety, identity, strength, quality, and purity intact Manufacturers Wholesale/ Distributors Pharmacies/ Hospitals Provide evidence that drug products are stored and shipped according to labeled storage conditions GOOD DISTRIBUTION PRACTICES Healthcare Providers Patient s

4 Good Distribution Practice Environmental Control Temperature Relative Humidity Light Importation and Exportation Procurement of authentic and quality materials and products Supply Chain Integrity and Security Oxygen Shock Vibration Adulteration, counterfeited, misbranded, expired Theft and diversion

5 <1079> Good Storage and Distribution Practices <1083> Good Distribution Practices (2013 Proposal Cancelled) Environmental Control Importation and Exportation Supply Chain Integrity and Security <1079> Good Storage and Distribution Practices (Official) Introduction Labeling Information Quality Management System Good Documentation Practices Storage Management System Distribution Management System Environmental Management System Risk Management System

6 <1079> Good Storage and Distribution Practices <1079> Good Storage and Distribution Practices Focus Storage and Transportation of Finished Drug Products All organizations and individuals involved in the storage and transportation of drug products Risk-Based Approach to the Storage and Transportation of Drug Products Risk Identification Mitigation Strategies

7 Risk-based Approach to Storage and Transportation Quality Management System Documentation Training Qualification/Validation Instructions, Schedules and Records INFORMATION Competence Development and Instructions Understanding COMPREHENSION Ensure suitability of the purpose Warehouse/Packaging System/Transportation ASSURANCE Mitigation Strategies Resources Capability through infrastructure and human resources MATERIALS Risk Identification The central idea is having a Quality System that is build based on risk. Generally, mitigation strategies are related to instructions (SOPs), training (ensure instructions understanding) and Qualification/Validation (warehouse temp map, packaging system, ERP software, process validation (in case of distribution, is the transport mode/route validation).

8 Risk Identification Product and process knowledge is the starting point in identifying risks related to the storage and transportation. Product knowledge: Intended use Storage conditions Potential hazards (to environment and personnel, e.g. hormones, cytotoxic drug products, radiopharmaceuticals, etc.) Inherent vulnerability (e.g. high potential of abuse; high value drugs; attractiveness cargo theft, counterfeiting, diversion. Process knowledge: Knowledge of supply chain partners Physical modes of transportation (air, sea, rail, or road) Transportation routes

9 Risk Identification Risk identification is the systematic use of information to identify potential sources of harm (hazards). Information can include historical data, theoretical analysis, informed opinions, product and process knowledge and the concerns of stakeholders. Risk identification addresses the what might go wrong? question.

10 Identified Risk RISK EFFECT Storage Improper entry to materials management systems: (wrong batch number, wrong expiration date, wrong status e.g. approved product that should be quarantined); wrong amount) Cannot have an accurate information of the stock Can pick and ship a product that was supposed to be quarantined but due to wrong status was marked as approved Product has been stored in the wrong physical location Picking issue mistakes (software will show the location however you can pick the wrong product if there is no check of physical placement) Product can face excursions Legal sanctions for Controlled Substance Risk of diversion for Controlled Substance

11 Identified Risk RISK Storage outside of labeled specification Temperature Monitoring Device Failure Storage EFFECT Affects product quality, integrity and patient safety (e.g. freezing of vaccine or biologic) Product loss (e.g. money) Out-of-range cold or hot areas; Product storage temperature excursion; Storage /Temperature System Failure due to: loss of electrical power failure of temperature control and air circulation systems unusual weather event Product loss Out-of-range cold or hot areas; Product storage temperature excursion; Product loss

12 Identified Risk RISK Receive an adulterated, falsified, recalled product Receive some product that was not ordered Mix-up of products with different status (Rejected/Recalled/Returned) Receiving/Shipping EFFECT Introduction into legitimate supply chain a product that is potentially substandard, illegal or counterfeited Unmatched transaction (e.g. wrong paper work/transaction data sent) Introduction into legitimate supply chain a product that is potentially substandard, illegal or counterfeited Shipping/selling of inappropriate product Shipping/Receiving delays due to inclement weather, natural disasters, traffic disruption Arrival delays Temperature out of specification (Temperature excursions, e.g. accidentally freezing when is snowing)

13 Risk-based Approach to Storage and Transportation Quality Management System Documentation Training Qualification/Validation Instructions, Schedules and Records INFORMATION Competence Development and Instructions Understanding COMPREHENSION Ensure suitability of the purpose Warehouse/Packaging System/Transportation ASSURANCE Mitigation Strategies Resources Capability through infrastructure and human resources MATERIALS Risk Identification The central idea is having a Quality System that is build based on risk. Generally, mitigation strategies are related to instructions (SOPs), training (ensure instructions understanding) and Qualification/Validation (warehouse temp map, packaging system, ERP software, process validation (in case of distribution, is the transport mode/route validation).

14 Mitigation Strategies Mitigation strategies fall within categories and are related to: Documentation: instructions for a specific operation or process in order to standardize and establish consistency Training: ensuring instructions are understood Qualification/Validation: the assurance that the processes and instrumentation are reliable, reproducible and robust. Resources: having capability through infrastructure and human resources (infrastructure and human)

15 Mitigation Strategies: Documentation Key documents that are fundamental for a QMS that supply chain partners can implement in their organizations: Quality Manual Standard Operating Procedures (SOPs) Recalls Returns Receiving Storage and Transportation Supplier Qualification Labels Quality Agreements Excursion Handling

16 Mitigation Strategies: Qualification/Validation Action Temperature Recording Devices Used for Temperature Mapping or Temperature Recording for Storage and Transportation Qualification (Facilities, Equipment, Thermal Packaging and Transportation Systems) Validation (Processes and Procedures) Calibration (Instruments or Devices) Manufacturers, Repackagers, Distributors, and Pharmacies Packaging designed to maintain temperature sensitive product within specific temperature ranges Manufacturers, Repackagers, Distributors, and Pharmacies (if shipping) Placement of Temperature Recording Devices within a storage area to monitor / record Temperature Manufacturers, Repackagers, Distributors, and Pharmacies (if shipping) Transportation Vehicles Manufacturers, Repackagers, Distributors, and Pharmacies(if shipping) Software or website verification of output Manufacturers & Repackages

17 Mitigation Strategies: Training / Resources Training is a critical process to communicate job expectations and to develop skills to effectively and efficiently execute daily responsibilities. Training should be covered in a training SOP Training may be: Instruction led by qualified instructors or subject-matter experts On-the-job training by a supervisor or other qualified personnel Web-based training or simulations. Training effectiveness determined Resources are storage, transportation and personnel. Storage Premises should be designed to maintain the quality and integrity of drug product stored Transportation All vehicles used in supply chain activities, such as semitrailer trucks, vans, trucks, trains, airplanes, sea vessels, mail delivery vehicles, and emergency medical services, should be suitable for the intended purpose. Personnel

18 Risk-based Approach to Storage and Transportation Quality Management System Documentation Training Qualification/Validation Instructions, Schedules and Records INFORMATION Competence Development and Instructions Understanding COMPREHENSION Ensure suitability of the purpose Warehouse/Packaging System/Transportation ASSURANCE Mitigation Strategies Resources Capability through infrastructure and human resources MATERIALS Risk Identification The central idea is having a Quality System that is build based on risk. Generally, mitigation strategies are related to instructions (SOPs), training (ensure instructions understanding) and Qualification/Validation (warehouse temp map, packaging system, ERP software, process validation (in case of distribution, is the transport mode/route validation).

19 Risks and Mitigation Strategies RISK EFFECT MITIGATION STRATEGY Improper entry to ERP-like systems: (wrong batch number, wrong expiration date, wrong status e.g. approved product that should be quarantined); wrong amount) Product has been stored in the wrong physical location Cannot have an accurate information of the stock Can pick and ship a product that was supposed to be quarantined but due to wrong status was marked as approved Picking issue mistakes (software will show the location however you can pick the wrong product if there is no check of physical placement) Product can face excursions Legal sanctions for Controlled Substance Risk of diversion for Controlled Substance Storage Stocking SOP Software validation Stocking SOP Automated checking system SOP that shows a list of products and their Temperature Specification SOP that shows a list of products and their license category (controlled, radiopharmaceuticals, etc.) MITIGATION CATEGORY/ AVENUE Documentation and Validation Documentation and Validation Documentation Documentation

20 Risks and Mitigation Strategies RISK EFFECT MITIGATION STRATEGY Environmental conditions out of specification Affects product quality, integrity and patient safety (e.g. freezing of vaccine or biologic) Storage Warehouse, packaging and transportation qualification (temperature mapping) MITIGATION CATEGORY/ AVENUE Qualification/Validation Documentation Temperature Monitoring Device Failure Product loss (e.g. money) Out-of-range cold or hot areas; Product storage temperature excursion; Product storage identification Back-up monitoring devices with independent power source Excursion handling SOP Documentation/Resources Storage /Temperature System Failure due to: loss of electrical power failure of temperature control and air circulation systems unusual weather event Product loss Out-of-range cold or hot areas; Product storage temperature excursion; Product loss Temperature and power alarms, Back-up power and coolant systems (redundant) and/or contingency storage; Excursion handling SOP Documentation/Resources

21 Risks and Mitigation Strategies Receive an adulterated, falsified, recalled product RISK EFFECT MITIGATION STRATEGY Receive some product that was not ordered Introduction into legitimate supply chain a product that is potentially substandard, illegal or counterfeited Unmatched transaction (e.g. wrong paper work/transaction data sent) Introduction into legitimate supply chain a product that is potentially substandard, illegal or counterfeited Receiving/Shipping Quarantine Quality Control test Packaging identification fingerprints Recall awareness Notify regulatory authorities or trading partners Receiving SOP and training MITIGATION CATEGORY/ AVENUE Documentation Documentation and Training

22 Risks and Mitigation Strategies RISK EFFECT MITIGATION STRATEGY Mix-up products with different status (Rejected/Recalled/Returned) Shipping/selling of inappropriate product Receiving/Shipping Product segregation Warehouse layout (logical flow and holding areas in order to avoid mix ups) MITIGATION CATEGORY/ AVENUE Documentation and Resources Shipping/Receiving delays due to inclement weather, natural disasters, traffic disruption Arrival delays Temperature out of specification (Temperature excursions, e.g. accidentally freezing when is snowing) Receiving SOP Reschedule the delivery Temporary parking (waiting for availability to unload). This could mean offloading to temperature controlled facility or vehicle Documentation Recondition materials to ensure temperature maintenance during delay Rescue Services

23 Role of Supply Chain Members Some Applicable Mitigation Strategies Manufacturer Role of the Organization within the Supply Chain Wholesaler Pharmacy/ Hospital/Health Brokers distributor Compounding care providers Pharmacy Freight Forwarders Documentation (Manuals, Procedures, Protocols, Records) Quality Manual Yes Yes Yes Yes Yes Yes Labeling Yes Yes Yes Yes No No Procurement Yes Yes Yes Yes Yes Yes Receiving Yes Yes Yes Yes No Yes Picking Yes Yes Yes Yes No Yes Packing Yes Yes Yes No No No Sales Yes Yes Yes No Yes No Storage Yes Yes Yes Yes No Yes Transportation Yes Yes Yes No 1 No Yes Supplier Qualification Yes Yes Yes Yes Yes Yes Customer Qualification Yes Yes No No Yes Yes Quality Agreements Yes Yes Yes Yes Yes Yes Licenses and Authorizations Yes Yes Yes Yes Yes Yes Recall Yes Yes Yes Yes Yes Yes Return Yes Yes Yes Yes No No Temporary parking No No No No No Yes Excursion handling Yes Yes Yes Yes No Yes Disposal of expired and rejected drug product Yes Yes Yes Yes No Yes Pest Control and Pallet Conservation Yes Yes Yes Yes No Yes

24 Role of Supply Chain Members Some Applicable Mitigation Strategies Manufacturer Wholesaler distributor Role of the Organization within the Supply Chain Pharmacy/ Hospital/Health Brokers Compounding care providers Pharmacy Freight Forwarders Training Yes Yes Yes Yes Yes Yes Resources Product segregation Yes Yes Yes Yes No Yes Storage area (layout/logical flow) Yes Yes Yes Yes No Yes 2 Maintenance Yes Yes Yes Yes No Yes Calibration Yes Yes Yes Yes No Yes Monitoring Systems and Alarms Yes Yes Yes Yes No Yes Appropriate number of personnel Yes Yes Yes Yes Yes Yes Organizational chart/job descriptions Yes Yes Yes Yes Yes Yes Qualification/Validation Temperature Mapping Yes Yes Yes Yes No Yes Shipping Packaging qualification Yes Yes Yes No 1 No No Software validation (automated checking systems, ERPs, ERP-like systems) Yes Yes Yes Yes Yes Yes

25 Conclusion Product and process knowledge is the starting point in identifying risks related to the storage and transportation The mitigation strategies should be put in place to off set the risk related to storage and transportation The mitigation strategies can be divided into four essentials pillars: Documentation Training Qualification/Validation Resources Identifying storage and transportation risk and putting in place the appropriate mitigation strategies will enhance quality assured processes, maintain product quality and supply chain integrity.

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