USP General Chapter <1079> Pharmacopeia Forum. for Drug Products

Transcription

1 USP General Chapter <1079> Pharmacopeia Forum Good Storage and Transportation Practices for Drug Products IATA Vancouver/March 8-12, 2010 Mary Foster, PharmD USP Expert Committee Member, Packaging, Storage and Transportation Vice President, Quality Catalent Pharma Solutions, Inc. 30

2 Agenda Introduction to <1079> Themes Systems Approach Practices to Support Drug Product Integrity Accountability Throughout Chain of Custody Transparency Throughout Chain of Custody How To Use Guide 31

3 Introduction to Revised General Chapter <1079> Current Aimed at geographically localized li activities, iti i.e. within NA Discusses distribution chain in separate entities terms Revision in Pharmacopeia Forum Global application and accountability Discusses complexity within distribution chain and links to all entities 32

4 Introduction to Revised of General Chapter <1079> Drug Products (Human; Veterinary; Clinical Trial) Manufacturers, packagers; repackagers; wholesalers; distributors; hospital, mail-order and retail pharmacies Contractor s site; Laboratories Transportation vehicles (aircraft; automobiles; vans; containers; railcars; ships; trucks (large and small) Including Emergency Medical Services (EMS) vehicles and ambulances (removed from USP <1070>) Mail distributors (postal services; expedited mail services, e.g. DHL; FedEx) Excludes APIs & excipients, however 33

5 Themes <1079> Systems To provide a management systems approach Life-cycle management based on science, evidence & justification Improve efficiency in the supply chain Definitions to the systems in the context of storage & transportation Quality System Storage System Environmental System Transportation System Risk System 34

6 Themes <1079> Practices To provide a management systems approach To recommend standard practices including controls and SOPs All drugs - not just cold chain All operational space All entities ttes 35

7 Themes <1079> Accountability To provide a management systems approach To recommend standard practices To discuss accountability Ensure drug life-cycle Safety, identity, strength, quality, and purity Joint venture throughout supply chain 36

8 USP General Chapter <1079> Revision Themes Good Storage and Transportation Practices for Drug Products Systems Practices Accountability 37

9 USP General Chapter <1079> Revision Themes Good Storage and Transportation Practices for Drug Products Systems Practices Accountability 38

10 Systems Approach Systems Quality System (QMS) Storage System (SMS) Environmental System (EMS) Risk System (RMS) Transportation System (TMS) 39

11 Systems Approach Systems Quality System (QMS) Storage System (SMS) Environmental System (EMS) Transportation System (TMS) <1079> QMS Risk System (RMS) Set of policies, processes & procedures (SOPs) that enable the identification, measurement, control and improvement of the storage and transportation of drug product Defined roles and responsibilities Purposefully building documented alliances [e.g., Quality Agreements or Collaborative Agreements] 40

12 Systems Approach Systems Quality System (QMS) <1079> QMS = Set of policies, processes & procedures that enable the identification, measurement, control and improvement of the storage and transportation of drug product SOPs/Defined roles/collaborative Agreements Establish load configurations in cargo hold areas Sub-contracted or non-dedicated vehicles used in airport transportation to/from aircraft Document deviations and investigations to defined root cause(s) Transparent change control Self inspections; corporate audits; allow customer audits? 41

13 Systems Approach Systems Quality System (QMS) <1079> QMS = Set of policies, processes & procedures that enable the identification, measurement, control and improvement of the storage and transportation of drug product SOPs/Defined roles/collaborative Agreements Measuring key elements to ensure procedures are adequately followed from receipt to delivery Controlling critical parameters to ensure storage and transportation conditions have been appropriate while in their control Understand requirements of all relative drug regulatory agencies within own country; and, global regulatory agency 42

14 Systems Approach Systems Quality System (QMS) Environmental System (EMS) Storage System (SMS) Transportation System (TMS) Risk System (RMS) <1079> EMS A section of the QMS that covers environmental controls, including an adequate organization structure, roles & responsibilities, SOPs/policies/standards and processes for developing and maintaining an environmental program 43

15 Systems Approach Systems Environmental System (EMS) <1079> EMS = A section of the QMS that covers environmental controls, including an adequate organization structure, roles & responsibilities, SOPs/policies/standards and processes for developing and maintaining an environmental program. Environmental controls/roles/sops Over the life-cycle stability profile of products - airline time included Building stability profiles that cover potential excursions based on travel - airline cargo areas; tarmacs; airline hold areas Resolutions to CAPA s; preventive programs put in place (e.g., alert mechanism for temp breaches) Requiring SOPs, documentation and justifications Symbols and icons 44

16 Systems Approach Systems Quality System (QMS) Environmental System (EMS) Storage System (SMS) Transportation System (TMS) <1079> SMS Risk System (RMS) Program to provide continuous improvement in the storage of drug products with key locations Buildings and facilities; vehicles and dispensing areas Basic processes Receiving/transferring; g storage/holding g 45

17 Systems Approach Systems Storage System (SMS) <1079> SMS = Program to provide continuous improvement in the storage of drug products with key locations in buildings and facilities, vehicles and dispensing areas. Storage program locations/processes Assures adequate controls (basics: extremes in temp, fire, water, explosion, pests) Prevent diversion 46

18 Systems Approach Systems Quality System (QMS) Environmental System (EMS) Storage System (SMS) Transportation System (TMS) Risk System (RMS) <1079> TMS Provide continuous improvement of drug product lifecycle by better and more efficient use of transportation processes 47

19 Systems Approach Systems Transportation System (SMS) <1079> TMS = Provide continuous improvement of drug product lifecycle by better and more efficient use of transportation processes Create transportation system that assures adequate product protection ti regardless of location Oversight program with accountability Notification to regulatory authorities Validation or qualification program for a vehicle should represent environmental extremes Temp map report define areas unsuitable; the minimum and maximum time allowances/tolerances 48

20 Systems Approach Systems Quality System (QMS) Environmental System (EMS) Storage System (SMS) Transportation System (TMS) Risk System (RMS) <1079> RMS A section of the QMS that covers the tools for determining how to handle deviations and excursions 49

21 Systems Approach Systems Risk System (SMS) RMS = <1079> A section of the QMS that covers the tools for determining how to handle deviations and excursions Process and SOPs when storage condition is not maintained Procedures when contamination ti is observed, e.g. pests, mold, moisture Security yprocedures Audit of transportation firms 50

22 1 2 3 Systems Practices Accountability 51

23 Standard Practices Practices Storage and Transportation Systems A B Warehouse Storage Hold Areas Vehicles Process Receiving Transferring Storing Holding Transporting Administering C Pharmacies Dispensers D End Users 1 Prevent preparation damage at times of uncontrolled storage. Limit it time out of storage conditions. Monitor and control temperature and act on deviations. 3 4 Determine if temperature mapping is required. Procedures and documentation required. 2 Determine temperature, air flow, and load patterns. Monitor 52and control temperature and act on deviations.

24 Standard Practices Practices Storage and Transportation Systems A B Warehouse Storage Hold Areas Vehicles Process Receiving Transferring Storing Holding Transporting Administering C Pharmacies Dispensers D End Users 1 Prevent preparation damage at times of uncontrolled storage. Limit it time out of storage conditions. Monitor and control temperature and act on deviations. 3 4 Determine if temperature mapping is required. Procedures and documentation required. 2 Determine temperature, air flow, and load patterns. Monitor 53and control temperature and act on deviations.

25 Standard Practices Practices Storage and Transportation Systems A Warehouse Storage Hold Areas B Vehicles - C Process Receiving Transferring Storing Holding Transporting e.g. Aircraft Pharmacies Dispensers Administering D End Users 1 Prevent preparation damage at times of uncontrolled storage. Limit it time out of storage conditions. Monitor and control temperature and act on deviations. 3 4 Determine if temperature mapping is required. Procedures and documentation required. 2 Determine temperature, air flow, and load patterns. Monitor 54and control temperature and act on deviations.

26 Standard Practices Practices Storage and Transportation Systems Process Environmental conditions (temperature, humidity, light) Receiving Storing Transporting Administering controlled and Transferring monitored Holding APreventive Warehouse Maintenance program in place Storage Environmental 4 Hold Areas monitoring i devices routinely calibrated at preset B Vehicles intervals with alert mechanism Communication within supply chain coordinated 2 to determine proper timing for receipt (and conversely be C Pharmacies transported) Dispensers - holidays, weekends or other forms of interruption D End Users Important consideration international shipments - customs stage supply chain 55

27 Systems Practices Accountability 56

28 Accountability and Responsibility Accountability Accountability and responsibility must be maintained from: Manufacturing through Administration Manufacturing Delivery Administration Supply Chain 57

29 Accountability and Responsibility Accountability Accountability and responsibility must be maintained from: Manufacturing through Administration Manufacturing Delivery Administration Supply Chain - Responsible Entity Applicant holder or manufacturer for non-application preparations Transparency: removed time frames from current chapter (upon 2 hours of receipt ) It should follow for API s, excipients 58

30 Accountability and Responsibility Accountability Accountability and responsibility must be maintained from: Manufacturing through Administration Manufacturing Delivery Administration Supply Chain - Responsible Entity Delivery process RECALL - if it is found in any part of the supply chain to be adulterated due to storage/transportation activities, including counterfeiting 59

31 Accountability and Responsibility Accountability Accountability and responsibility must be maintained from: Manufacturing through Administration Manufacturing Delivery Administration Supply Chain - Responsible Entity Administration and End User Entities Key to final safety, identity, strength, quality and purity 60

32 Accountability and Responsibility Accountability Accountability and responsibility must be maintained from: Manufacturing through Administration Manufacturing Delivery Administration Supply Chain - Responsible Entity All entities along the supply chain - ensure they handle appropriately for temperature t and other causes of preparation adulteration 61

33 Concluding Points General Intended to provide guidance on drug product lifecycle practices along the supply chain inclusive of all relative entities and the associated requirements that must be in place to protect preparations Joint venture mentality as an expression of the need for harmonization and transparency across all stakeholders for critical supply chain aspects such as environmental excursions for the benefit of the patient Equally important is to stay current and be ready to change as new solutions evolve 62