guidance for storage and transport of time and temperaturesensitive pharmaceutical products WHO Technical Report Series no961 2011 Annex 9 amp Technical supplements Umit KartogluDenis ID: 133062
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Slide1
Model
guidance for storage and transport of time and temperature-sensitive pharmaceutical products (WHO Technical Report Series, no.961, 2011, Annex 9) &Technical supplements
Umit Kartoglu/Denis MaireEssential Medicines and Health ProductsSlide2
Developed by the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain ManagementBased upon existing regulations and best practice guidance from a wide range of international sources
For regulators, logisticians and pharmaceutical professionals in the industry, government and international agenciesThe guidance should be directly applicable in less-developed countries as well as in the industrialized world.
The MODEL GUIDANCE (Annex 9)WHO Technical Report Series, no.961, 2011Slide3
Bring developed country methodologies to bear on developing country cold chain management
Define minimum requirements for storing and transporting time & temperature-sensitive pharmaceutical productsDevelop a document that covers all key components of the supply chain
Objectives
BuildingsEquipment
Transport
Management procedures
The WHO guidelineSlide4
The TASK FORCE –
41
members, 35
organizations
,
19 countries
consultation
Public review
ECBS* and ECSPP** submission
ProcessSlide5
Matrix display
OverlapsConflicting areasGaps
Collection of documentsUSP Chapter 1079Health Canada Guide 0069 EC DirectivesIrish Medicines Board…
Development of minimum standards
Draft document
Reviews by the Task Force
Submission to ECBS
2011
Extended reviews
2009-2010
Process
Regulatory oversight on pharmaceutical
cold chain management TFSlide6
Guidance harmonization process
Document review processSlide7
Document review processSlide8
Importation
Main section headings
Warehouse sites
Storage buildings
Temperature-controlled storage
Materials handling
Transport and delivery
Stock management
General procedures and record keeping
Labelling
Environmental management
Quality management
Personnel training
The WHO guidelineSlide9
Main section headings
Example: Typical clause format
The WHO guidelineSlide10
Encourage member states to adopt good cold chain practices
Ensure that guidance takes account of developing country constraintsMaintain and develop the package in line with best practiceIn
support to the guideline, develop supplementary model guidance modules as a reference for good practices enhancement
Next steps
The WHO guidelineSlide11
The WHO guideline
GUIDELINES – Tell only
WHAT
needs to be doneSlide12
Importation and port clearing (MSH)Warehouse site selection
Warehouse designEstimating warehouse storage capacityBuilding security and fire protectionBuilding maintenanceTemperature monitoring of storage areasTemperature mapping of storage areas
Qualification of temperature controlled storage areasCalibration of control and monitoring devicesCold chain equipment maintenanceGuidelines for warehousing health commodities (JSI)Transport route profiling qualificationTemperature and humidity control during transport
Qualification of temperature controlled road vehiclesQualification of shipping containersPacking shipping containers and refrigerated vehiclesEnvironmental management of refrigeration equipment
Technical Supplements – Cold chain functions covered
Tell
HOW it can be done – focus on topics not well addressedSlide13
Abbreviations
GlossaryRequirements and objectivesRequirementsObjectivesTarget audience
Associated materials and equipmentProcedureRelated documents and referencesRevision history
Technical Supplements - General structureSlide14
Requirements
Model Guidance
Temperature mapping of a storage areaSlide15
Figure 2 – Typical location of data loggers in a walk-in cold room
Procedure
Step-by-stepAs much detail as necessary to performCriteria for acceptance
Illustrations, graphics, flow charts and tables all in one style, newly createdNecessary annexes such as blank formsSlide16
References and annexes
International standardsOther references
If in public domain, hyperlinksAnnexesSlide17
Communication
Electronic publishingDistribution to all Regulatory agencies, Ministries of Health, international organizations, public and private pharmaceutical industry, supply chain professionals
Incorporate in syllabus - Pharmaceutical cold chain management on wheels and the e-learning coursePresentation at international conferences (TechNet, PDA, IQPC, VIB) Slide18
Feedback before finalization
Technical Supplements can be downloaded at:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/
Send your comments to kartogluu@who.intFeel free to further distribute the draft document