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Titel van presentatie | datum van presentatie
Chapter 3 of GDP Requirements : Premises & Equipment COOL SUPPLY SYSTEM & SOLUTIONS
19th and 20th of March 2015
Riekert Bruinink
GMP/GDP inspector
Dutch Healthcare Inspectorate
1. Chapter 3 : Premises and Equipment
•Wholesale distributors should have suitable and adequate
premises, installations and equiment, as so to ensure proper
storage and distribution of medicinal products. In particular
the premises should be clean, dry and maintained within
acceptable temperature limits.
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1. Premises and equipment ( Chapter 3 )
• Premises : construction / separation of goods
• Temperature mapping
• Equipment : maintenance / repair /calibration
• Computerised Systems validation
• Qualification and validation key equipment
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Agenda
1. Premises
2. Temperature management
3. Qualification and validation
4. Cases
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1. Premises
• Suitable and adequate
• Sufficient capacity
• Receiving and dispatch bays should protect
• Adequate separation of goods
• Receiving / dispatch /storage area
• Narcotic drugs / hazardous goods
• Unauthorised acces should be prevented
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1. Premises : Construction / Capacity
•The premises should be suitable, structurally sound, provided
• with adequate lighting and of sufficient capacity..
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1. Premises : capacity / appropriate storage ( at the right)
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1. Premises : receiving / dispatch products
•Receiving bays and dispatch bays should protect products from
prevailing weather conditions
• Unloading and loading products can have influence on
temperature
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1. Chapter 3 : Separation of goods
• Separation either physically or through an equivalent validated
electronic system ( general rule with exceptions)
• Chapter 3/5 - stored separately from other
products likely to alter them
- stored physically apart and
based on validated system
for rejected , expired and
recalled products;
- for falsified medicinal products
and returns as well.
- dedicated on hold area
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1. Premises : Which area’s are necessary ?
• Receiving area
• Storage area
• On hold area
• Dispatch area
• Rest,wash refreshment rooms
• Offices
• Separation inbound /outbound
during the day
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1. Chapter 3 : Narcotics / Hazardous products
• Radioactive materials / hazardous products
• Narcotic drugs
• Part of National Laws and International Rules
• Differences between Member States
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2. Temperature management
• System for heating/cooling
• Temperature mapping : how long, where, when ?
• Temperature monitoring at the right places
• Control temperature periodically
• Appropriate alarm system
• Managing alarms / excursions
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2. Temperature mapping
• Why : temperature behavior varies
• What : freezers, refrigerators , storage area for
ambient products , trucks etc.
• How ? : Measuring temperature at several locations
on a three dimensional plain.
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2.Temperature mapping
• When : initial before using a storage facility
summer / winter (OQ/PQ)
after significant changes
risk based
• Start : identify places which a higher or lower
temperature : heaters, doors , windows etc.
• How long : At least 2 days/ one week
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2. Temperature mapping
• Results : temperature data
warmest/coldest places
• Conclusion : Temperature within specification ?
Warmest / coldest spots ?
Place monitoring devices
Storage may be not possible at certain places
• Rapport : Method/ findings/ conclusions
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2. Temperature management : Results of GDP inspections
• Results : Monitoring , registration, control : 94 % .
Weak system : 18%
Temperature mapping : 62 %
Temperature mapping (S and W) : 27%
Alarm system : 65 %
Follow-up alarm :50 %
• Remarks : Sometimes only one device
Sometimes temperature excursions
without actions ; alarms on temperature
monitoring device.
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3. Qualification and validation
• Identify what key equipment and/or key process
qualification / validation is necessary.
• The scope and extend should be determined
using a risk assessment approach.
• Efforts should be established in the validation
master plan.
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3. Qualification and Validation : examples
• Temperature behaviour building
• Temperature behaviour cool area
• Air handling units
• Access control
• Alarm systems
• Safety and security systems
• Processes : for example handling cool storage products
• Transportation (company)
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3. Qualification and validation
• Computerized systems should be validated accor-
ding to approved protocols prior to their use.
• Systems already in place should also be validated.
• The extend depends on the risk to or impact of
the software on product or service quality.
• It isn’t applied to software that has no impact
on quality.
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3. Qualification and validation
• A written description of the system should be in
place.
• The document should describe principles,
objectives, security measures , how it is used etc.
• Authorization
• Make a back up at regular intervals
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4. Case Facilities
Case : medium wholesaler with their own storage facilities
Deficiencies
• Some loading bays and one ‘ open door ‘
• Temperature too low during winter near this door
• Status of some products not clear
• On hold area not present ; storage only based on
the validated warehouse management system
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4. Case temperature mapping
Case : wholesaler with a report of a winter temperature
mapping (15-25 ); method and results described
Deficiencies
• Temperature mapping only in winter
• No conclusion at all
• No conclusion about places of continuous monitoring
• Lowest and highest temperatures not mentioned, only graphics
• No identification places with risk before mapping
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4. case : insufficient qualification of transportation companies
Case : Inspection parallel wholesale distributor 2014
- transportation national and international in EU by 5
companies
- cold chain and ambient products
- 600 products registrations
Result
• Major deficiency for qualification of transportation companies
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4.Case :insufficient qualification of transportation
Questions
• Audits performed ? : No only one visit
• Signed contracts available ? : 3 contracts / 1 sufficient
• Quality of the contracts ? : one contract without quality/GDP
appointments
use of sub-contractors ?
temperature mapping trucks?
• Do you have damaged goods ?: regularly with one company /
problems with financial claims
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