CHINA. Bio & Pharma Logistics Andrew McDonald Operations Director, Asia Pacific Melbourne, Australia, 27th March 2013 Australia - China Life Science Summit
Responsibilities Who takes responsibility on ensuring compliance at each stage of the logistic chain? What is the view of the regulators? The manufacturer is responsible to ensure that adequate systems are in place to maintain product quality during a. Storage and distribution b. Throughout shelf-life Reinforced recently by FDA at a conference in Washington
Logistics Deficiencies 43% of critical and major deficiencies are related to the control and monitoring of the storage and transportation temperatures* 25% of all vaccine products reach their destination in a degraded state** MHRA - Top 5 GDP deficiencies*** o lack of, or inadequate written procedures o general storage, temperature control and monitoring o cold chain transportation o unauthorized activity o cold storage - temperature control and monitoring *: John Taylor (MHRA), Regulatory Expectations, IQPC Cool Chain 2008, Brussels, Belgium **: Black, A., E Logistics in Cold Chain Management, quoting WHO ***: April to June 2009, http://www.mhra.gov.uk/howweregulate/medicines/inspectionandstandards/gooddistributionpractice/faq/index.htm
Logistics Deficiencies Premises and Equipment / Orders and Supply or both 8% Product 5% Temperature Conditions 30% Documentation 24% *UK Sites Only - Ian Holloway (MHRA), Observations and Guidance, IQPC 8th Cold Chain Distribution for Pharmaceuticals Global Forum, September 20-23, 2010, Philadelphia Quality Management Systems 25%
China & GSP New Good Supply Practices (GSP) for Pharmaceutical Products Adopted by Ministry of Health SFDA State Food & Drug Administration Effective 1 st June 2013 3 Year transition period Strict compliance from 2016 The revised rules establish higher standards for quality controls in drug distribution and supply chain management
Good Supply Practices The main contents of the new GSP require; A comprehensive information system Warehouses to be equipped with temperatures & humidity monitoring Standardized documentation for the sale of all drugs & documentation to travel with the drug shipment Better quality assurance practices from ALL drugs transportation providers Electronic drug monitoring systems with specific operations processes That legal representatives or responsible persons for drug retailing be licensed pharmacists
Logistics Chain Increase number of players - 3PL storage - Courier / Distributor - Airlines / Staging Hub - Customs / CIQ / Security Each point is a potential area for mishandling Role of the service provider is magnified it is critical to have a service partner that can manage the full scope Critical Control Points Quality system - Processes - Knowledge Management Technology - Packaging - Temperature Control People - Training - Experience
Observations Road Vehicles & Cold Chain - City limit restrictions for larger vehicle means smaller vehicles are only possible to enter downtown areas - Vehicle registrations have restrictive national licenses which may inhibit provincial moves - Limited availability of qualified and pharma specific performing vehicles - Ensure that providers have a quality system - Compliant storage facilities and transit locations.
Observations Air Air & cold chain - Wide range of extreme temperatures across the nation - Limited storage facilities across the various airport infrastructures - Significant security restrictions on liquids and also bulk powders - Security requirements are demanding requiring actual testing of commodity by independent party to ensure non DG in most cases MSDS not acceptable.
CTA Application Overview ASC: Administrative Service Centre SFDA: State Food & Drug Administration CDE: Centre for Drug Evaluation NIFDC: National Institute for Food& Drug Control DOSSIER COMPILATION DOSSIER FILING 1 x Day FORMAT REVIEW BY ASC 30 Days 30 Days CDE REVIEW 90 Days REQUEST FOR ADDITIONAL INFO REVIEW ADDITIONAL INFO PROCESS 150 TO 260 DAYS QC by NIFDC 60 to 90 Days CDE DECISION 30 Days SFDA CTA APPROVAL
Shipment import Permit Check Documents DATA Entry Online APPLICATION SFDA PRINT HARD COPY of APPLICATION SFDA DRFP Drug Registration Forms Program IMPORTER to ENDORSE PRESENT ALL Documents to SFDA IMPORT PERMIT OBTAINED PERMIT READY AT AIRPORT DRUG TRANSIT & IMPORT
Import Process PERMIT READY AT AIRPORT FLIGHT ARRIVAL CARGO STORED OBTAIN DOCS PRESENT DOCs to CUSTOMS 2 to 4 hr CUSTOMS INSPECTION 1 to 2 hr CIQ INSPECTION Cold Chain Control Point 85% PRESENT DOCs to CIQ 98% CLEAR to Deliver SFDA: CIQ : State Food & Drug Administration China Inspection & Quarantine
Inspections & Responsibilities Customs China VAT 17% Duty 5 % to 10% (Value + Freight + Duty) Permits Required & Available Accepted Commodity? China Inspection & Quarantine Gross weight & Pieces (CIQ) Net Product Quality Control Both Import & Export Actual vial / quantity / dosage Health & permit compliance Lot & Batch Numbers Expiry dates
Partnership Controls & Access : Brokers & Inspections & Replenishment Utilise brokers that are experienced with temperature control & open to work with your transport provider Understand & anticipate storage v packaging & required instructions Access for dry ice, change gel packs & Temperature control during transport? Considering storage minefield & access complications packaging is a critical issue to get right!
Packaging Passive Systems VIP Systems with Phase Change Materials VIP = Vacuum Insulated Panels o 5 to 7 times better than polyurethane / polystyrene Phase Change Material o Scientifically designed to store / release energy at specific temperature World Courier Systems are reusable - VIP & GTC Temperatures +2ºC to +8ºC, +15ºC to +25 ºC, -25ºC to -15ºC Sizes o GTC 4L, 12L, 28L, 56L, 96L, 406L*, 890L* *Pallet units o VIP 3L, 10L, 45L, 102L, 324L, 1244L*, 1830L* & 2530L*
Packaging Passive Systems GTC VIP
Packaging Active Containers C-Safe (Accutemp) Growing in our region Envirotainer Well known & available Insulated : Foam (e1) & VIP Panels (C-Safe) Active Heating & Cooling (compressors, batteries & generators) Plug capabilities at transit & destination during clearance Avoid dry ice only containers SOPs are Critical (QEP) Great solution for Bulk Product
Packaging Active Containers - Envirotainer e1 - London to Beijing Text
Partners Training & SOPs Global Approach with Local Control How? Standard Operating Procedures (Over 46 global SOPs) o Temperature Control o Equipment Management o Communication o Controls Checklists and Milestone checks Training Matrix & Records Local Experience and support
Quality Quality Program - BOTH Transport & Storage divisions GXP Good Clinical, Distribution, Storage, Manufacturing Practices ISO 9001 ISO 14001 Good Supply Practices - China A Robust Quality Program that includes Compliance Regulatory & Quality Training Policy / Matrix / Job Roles Documentation (Policies / SOPs) Change Control Management reviews Qualification of: Vendors / Suppliers /Providers Management
CTSCS Solutions The Right Solution for China GMP Compliant Facilities Bulk Imports as opposed to individual imports to sites o Complex clearances and permits completed once Product Stored at In Country Depot o Expedited response time from request to delivery o Direct & Customise distribution to sites o Happy Investigators and Patients Strategic Locations o Asia Pacific: China, Australia, Singapore, India, Japan o Latin America: Mexico, Colombia, Peru, Chile, Argentina, Brazil o Additionally: Russia & South Africa
CTSCS Solutions Clinical Trial Supply Chain Solutions Refrigerated Storage +2ºC to +8º Controlled Ambient +15ºC to +25ºC Frozen Storage Returns & Destruction Services Relabeling Expiry Extensions World Courier Management Inc. 2012. All Rights Reserved. Use, Duplication or Sale of this product except as authorized in writing by World Courier Management Inc. is strictly prohibited. This product contains propriety information of World Courier Management Inc.
Thankyou! Andrew McDonald Operations Director, Asia Pacific amcdonald@worldcourier.com.au Established in 1969 Over 13,000 associates worldwide Average Management Experience 17 Years Average Employee Experience 9 years Wholly owned office network of over 150 offices in 52 countries World Courier has been involved in over 10,000 clinical trials worldwide 13 x GMP compliant investigational drug storage depots in emerging markets GXP compliant global delivery systems World Courier Management Inc. 2012. All Rights Reserved. Use, Duplication or Sale of this product except as authorized in writing by World Courier Management Inc. is strictly prohibited. This product contains propriety information of World Courier Management Inc.