Inspection of Blood Establishments

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Inspection of Blood Establishments
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GROUP 1

• First, we would like express our sincere thanks
  and appreciation to our friends and colleagues
  from IBTO for hosting this workshop, hospitality,
  patience and the very well organized services.

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GROUP 1

• Sure many thanks to WHO- HQ and WHO-EMR for
  their continuous support in all aspects of BTS
  hoping that step by step the blood transfusion we
  will improve quality and safety of blood and
  blood products and looking forward at
  implementing GMP in the our field

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1. How to Perform an Inspection of Blood
Establishment

• Preparation for an inspection
• Conducting an inspection
• Inspection report
• Follow up of an inspection

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Preparation of an inspection of IBTO and
conducting it

• Preparation of an inspection
• Meeting the leading experts and facilitators to
  learn how to perform inspection
• Learn from the IBTO what is there mission,
  mandate, organization structure, future planes
• Decide the departments, date of the inspection
  (blood donor center, blood components
  preparation, blood and blood components storage,
  lab. Testing etc) 2,3/11/2008
• Select team of inspectors ( 17 inspectors from 9
  countries)

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2.How We Conducted the Inspection

• A systematic based inspection based on our
  knowledge on GMP standards
• Quality management
• Personnel and job description
• Premises and equipment
• Quality assurance (collection, preparation,
  testing, storage, release and transportation)
• Documentation
• Training
• Contracts
• Complaints and recall

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• During our inspection we realize that the
  services offered by the IBTO are very extensive
  and time available is very limited and also the
  number of inspectors was high enough to be
  accommodated in the facility.
• So we decided to reduce the inspection by just
  over viewing the quality of the services offered
  by the center in certain departments.

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Observation

• Organization
• This is a well organized institution, with a
  well trained personnel
• Personnel and job description
• The personnel are well trained and adhere to SOPs
  - GMP

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Observation

• Premises and Equipment
• Premises were in accordance with general
  requirements for BTS
• Organized
• Clean
• Well maintained
• Relatively systematic flow
• Adequate premises for duties assigned
• Equipments were well maintained, clean and
  qualified

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Observation

• Donor identification, suitability and acceptance
• Standardized donor identification and selection
  criteria performed by well trained staff
  according to SOPs and modern software in use
• Blood/plasma collection
• Separated area
• Hiegyne
• Clean and maintained equipments
• Biosealer
• Staff adhering to GMP( SOPs, Universal
  precautions)

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Observation

• Processing and preparation of blood components,
  storage
• Separated area, clean and well maintained
• In accordance with SOPs
• Close system and SCD were in use
• Facilities for segregate separation of storage
  area with a system for blood cold chain (temp.
  recording and monitoring)

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Observation

• Release and transportation
• SOPs for
• Handling of returned products
• Handling of reactive product
• Storage and stock control
• Documentaion
• Software MAK program
• Back up system
• Hard copy

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Observation

• Laboratory testing
• Separated area
• Clear flow of samples
• Cleaning and disinfection (SOPs)
• Equipments clean and maintained
• Trained staff
• Staff adhering to GMP( SOPs, Universal
  precautions)

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3. Lesson learned needs identified in the region

• IBTO provides the best practice model in the
  region by having
• -Organization and centralized services were it is
  needed
• 100 VNRBD
• Gov. and staff commitment
• - Contract for plasma fractionation
• Iran experience of contract for plasma
  fractionation give the region the opportunity to
  think seriously and plan for establishing a
  plasma manufacturing plant in the region

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• However we need to strengthen the existing
  national blood programs by reviewing all aspects
  of GMP with the goal of assuring the quality and
  safety of our blood supply.
• Strength
• Commitment from gov.
• Infrastructure
• Paid donation stopped
• Organization

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weakness

• Organization
• NRA
• Collection- VNRBD
• Software data base
• Training and training facilities
• However we realize that this a long term process

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Needs

• Accordingly, we need to look at
• Centralization of the services were it is needed
• Review and Promote existing GMP standards to in
  accordance with WHO guidelines
• Establish NRA and train inspectors in the blood
  establishments to enforce adherence to
  international GMP standards in the region
• To promote the sharing of experience and
  cooperation regionally and globally in GMP in
  blood establishments

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Needs

• 5. Establish same ethical standards in GMP
  guidelines for all kinds in blood establishments
• 6. Software data base and country BTS network
• 7. Training of staff and promoting the training
  of expertise in GMP
• 8. Afganistan needs more support in the field of
  BTS

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• THANKS VERY MUCH TO IBTO
• THANKS FOR WHO
• THANKS FOR ALL