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1. Basic Principles of GMP
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Module10 Slide1of26 2012
Equipment
13

2. Equipment
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Objectives
 To review the requirements for equipment
 selection
 design
 use
 maintenance
 To discuss problems related to issues around selected items of
equipment

3. Equipment
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Principle
 Equipment must be
 located
 designed
 constructed
 adapted
 maintained
to suit the operations to be carried out
13.1

4. Basic Principles of GMP
 What does
 location
 design
 construction
 adaptation
 maintenance
 cleaning
 calibration
… mean in practice?
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5. Equipment
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Principles
 Equipment layout and design must aim:
 to minimize risks of error
 to permit effective cleaning and maintenance
 To avoid:
 cross-contamination, dust and dirt build-up
 any adverse effect on the quality of products
 Equipment must be installed to:
 minimize risks of error
 minimize risks of contamination
13.1, 13.2

6. 13.3, 13.4
Equipment
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Pipes
 Fixed pipework
 clearly labelled
 indicate contents and direction of flow
 Service pipings and devices
 adequately marked
 non-interchangeable connections or adaptors for
dangerous gases and liquids

7. Basic Principles of GMP
Contents and direction of flow
indicated
 e.g. water lines, equipment
components, air-handling
systems
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8. 13.5
Equipment
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Balances and Measuring Equipment
 Appropriate range and precision available
 In production and quality control
 Calibrated
 scheduled basis
 checks
 records maintained

9. Equipment
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Production equipment
 Appropriate design
easily and thoroughly cleaned on a scheduled
basis
procedures and records
 No hazard to the products
contact parts of suitable non-reactive materials
non additive and
not absorptive
13.9, 13.10

10. 13.11 – 13.13
Equipment
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Production equipment
 Closed equipment used when possible
 Open equipment, or when equipment opened, precautions
taken to prevent contamination
 Non-dedicated equipment cleaned according to validated
cleaning procedures between different products
 Current drawings of critical equipment and support systems
maintained

11. Basic Principles of GMP
Current drawings of critical
equipment
 Verify against qualification
protocol and report, as well
as supplier's manual
 Check if in accordance with
drawing, or changes (change
control)
 Verify critical components
installed, e.g. filters, control
and monitoring devices
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12. Basic Principles of GMP
 What are the questions you
can ask about this piece of
equipment?
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13. Basic Principles of GMP
 And for this one?
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14. Basic Principles of GMP
 What do these labels
indicate for this piece of
equipment?
 Do you notice any GMP
non-compliances here?
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15. Basic Principles of GMP
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16. Basic Principles of GMP
 What are some of the key
questions you can ask about
the blender?
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17. Basic Principles of GMP
 Transfer of material to the
compression machine
through a closed system is
preferred to prevent possible
contamination
 It also helps to contain dust
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18. Basic Principles of GMP
 Remember to look at
punches and dies
 Are there specifications for
these?
 How are they cleaned,
stored, issued for use and
returned to storage?
 Are they in a good
condition and checked at
regular intervals?
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19. Basic Principles of GMP
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20. Basic Principles of GMP
Coating of tablets
 Is qualification of a coating
machine necessary?
 If so, what has to be done?
 What about maintenance?
 And cleaning validation?
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21. Basic Principles of GMP
 Don't forget the packaging
lines!
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22. Equipment
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 Quality control equipment and instruments
 suitable for the tests to be performed
 Defective equipment in production and quality control should be
 Removed; or
 Labelled (to prevent use)
13.7, 13.10

23. 13.6, 13.8
Equipment
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Washing, cleaning and drying
 Equipment used for washing and drying – not the source of
contamination
 Equipment design should promote easy cleaning
 Cleaning on scheduled basis, procedures and records
 Washing and cleaning
 manual
 automated (Clean in place (CIP), Steam in place (SIP))

24. Equipment
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Group Session
 For the given type of equipment
 What would your concerns be in relation to the manufacture
of products, when inspecting this particular piece of
equipment?
 What are the signs of poor practice in cleaning, operation
and maintenance?

25. Basic Principles of GMP
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26. Equipment
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Possible Issues
 Poor design
 Lack of safety
 Poor quality finishes
 Lack of cleaning
 Lack of maintenance
 No usage log or record
 Use of inappropriate weighing equipment
 Open-plan location of compressing machines