Transcript Inspection of Blood Establishments

Inspection of Blood
Establishments
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.
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
1. How to Perform an Inspection
of Blood Establishment
Preparation for an inspection
Conducting an inspection
Inspection report
Follow up of an inspection
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)
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
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.
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
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
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)
Observation
Processing and preparation of blood
components, storage:
•
•
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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)
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
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)
3. Lesson learned &needs
identified in the region
1. 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
2. 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
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
weakness
• Organization
• NRA
• Collection- VNRBD
• Software data base
• Training and training facilities
However we realize that this a long term
process
Needs
Accordingly, we need to look at:
1. Centralization of the services were it is needed
2. Review and Promote existing GMP standards
to in accordance with WHO guidelines
3. Establish NRA and train inspectors in the
blood establishments to enforce adherence to
international GMP standards in the region
4. To promote the sharing of experience and
cooperation regionally and globally in GMP in
blood establishments
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
THANKS VERY MUCH TO
IBTO
THANKS FOR WHO
THANKS FOR ALL