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1、Module 10 | Slide 1 of 26 January 2006 Basic Principles of GMPEquipment13Module 10 | Slide 2 of 26 January 2006 EquipmentObjectiveslTo review the requirements for equipment selection design use maintenancelTo discuss problems related to issues around selected items of equipment Module 10 | Slide 3 o
2、f 26 January 2006 EquipmentPrinciple lEquipment must be locateddesignedconstructedadaptedmaintainedto suit the operations to be carried out13.1Module 10 | Slide 4 of 26 January 2006 Basic Principles of GMPlWhat doeslocationdesignconstructionadaptationmaintenancecleaningcalibration mean in practice?M
3、odule 10 | Slide 5 of 26 January 2006 EquipmentPrincipleslEquipment layout and design must aim:to minimize risks of errorto permit effective cleaning and maintenancelTo avoid:cross-contamination, dust and dirt build-upany adverse effect on the quality of productslEquipment must be installed to:minim
4、ize risks of errorminimize risks of contamination13.1, 13.2Module 10 | Slide 6 of 26 January 2006 13.3, 13.4EquipmentPipeslFixed pipeworkclearly labelledindicate contents and direction of flowlService pipings and devicesadequately markednon-interchangeable connections or adaptors for dangerous gases
5、 and liquidsModule 10 | Slide 7 of 26 January 2006 Basic Principles of GMPContents and direction of flow indicatedle.g. water lines, equipment components, air-handling systemsModule 10 | Slide 8 of 26 January 2006 13.5EquipmentBalances and Measuring EquipmentlAppropriate range and precision availabl
6、e lIn production and quality controllCalibratedscheduled basischecks records maintainedModule 10 | Slide 9 of 26 January 2006 EquipmentProduction equipmentlAppropriate designeasily and thoroughly cleaned on a scheduled basisprocedures and recordsNo hazard to the productscontact parts of suitable non
7、-reactive materialsnon additive and not absorptiveDefective equipmentremoved, orlabelled to prevent use13.9, 13.10Module 10 | Slide 10 of 26 January 2006 13.11 13.13EquipmentProduction equipmentlClosed equipment used when possiblelOpen equipment, or when equipment opened, precautions taken to preven
8、t contaminationlNon-dedicated equipment cleaned according to validated cleaning procedures between different productslCurrent drawings of critical equipment and support systems maintained Module 10 | Slide 11 of 26 January 2006 Basic Principles of GMPCurrent drawings of critical equipmentlVerify aga
9、inst qualification protocol and report, as well as suppliers manuallCheck if in accordance with drawing, or changes (change control)lVerify critical components installed, e.g. filters, control and monitoring devicesModule 10 | Slide 12 of 26 January 2006 Basic Principles of GMPlWhat are the question
10、s you can ask about this piece of equipment?Module 10 | Slide 13 of 26 January 2006 Basic Principles of GMPlAnd for this one?Module 10 | Slide 14 of 26 January 2006 Basic Principles of GMPlWhat do these labels indicate for this piece of equipment?lDo you notice any GMP non-compliance?Module 10 | Sli
11、de 15 of 26 January 2006 Basic Principles of GMPModule 10 | Slide 16 of 26 January 2006 Basic Principles of GMPlWhat are some of the key questions you can ask about the blender?Module 10 | Slide 17 of 26 January 2006 Basic Principles of GMPlTransfer of material to the compression machine through a c
12、losed system is preferred to prevent possible contaminationModule 10 | Slide 18 of 26 January 2006 Basic Principles of GMPlRemember to look at punches and dieslAre there specifications for these?lHow are they cleaned, stored, issued for use and returned to storage?lAre they in a good condition and c
13、hecked at regular intervals?Module 10 | Slide 19 of 26 January 2006 Basic Principles of GMPModule 10 | Slide 20 of 26 January 2006 Basic Principles of GMPCoating of tabletslIs qualification of a coating machine necessary?lIf so, what has to be done?lWhat about maintenance?lAnd cleaning validation?Mo
14、dule 10 | Slide 21 of 26 January 2006 Basic Principles of GMPlDont forget the packaging lines!Module 10 | Slide 22 of 26 January 2006 EquipmentControl laboratory equipmentlEquipment and instrumentssuitable for the tests to be performedlDefective equipment removedlabelled13.7, 13.10Module 10 | Slide
15、23 of 26 January 2006 13.6, 13.8EquipmentWashing, cleaning and dryinglEquipment used for washing and drying not the source of contaminationlEquipment design should promote easy cleaninglCleaning on scheduled basis, procedures and recordslWashing and cleaningmanualautomated (Clean in place (CIP), Ste
16、am in place (SIP)Module 10 | Slide 24 of 26 January 2006 EquipmentGroup SessionlFor 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 ma
17、intenance? Module 10 | Slide 25 of 26 January 2006 Basic Principles of GMPModule 10 | Slide 26 of 26 January 2006 EquipmentPossible IssueslPoor designlLack of safetylPoor quality finisheslLack of cleaninglLack of maintenancelNo usage log or recordlUse of inappropriate weighing equipmentlOpen-plan location of compressing machines
