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1、Basic Principles of GMP,Equipment,13,Equipment,Objectives To review the requirements for equipment selection design use maintenance To discuss problems related to issues around selected items of equipment,Equipment,Principle Equipment must be located designed constructed adapted maintained to suit t
2、he operations to be carried out,13.1,Basic Principles of GMP,What does location design construction adaptation maintenance cleaning calibration mean in practice?,Equipment,Principles Equipment layout and design must aim: to minimize risks of error to permit effective cleaning and maintenance To avoi
3、d: 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, 13.2,13.3, 13.4,Equipment,Pipes Fixed pipework clearly labelled indicate contents and direction of flow Service p
4、ipings and devices adequately marked non-interchangeable connections or adaptors for dangerous gases and liquids,Basic Principles of GMP,Contents and direction of flow indicated e.g. water lines, equipment components, air-handling systems,13.5,Equipment,Balances and Measuring Equipment Appropriate r
5、ange and precision available In production and quality control Calibrated scheduled basis checks records maintained,Equipment,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-reac
6、tive materials non additive and not absorptive Defective equipment removed, or labelled to prevent use,13.9, 13.10,13.11 13.13,Equipment,Production equipment Closed equipment used when possible Open equipment, or when equipment opened, precautions taken to prevent contamination Non-dedicated equipme
7、nt cleaned according to validated cleaning procedures between different products Current drawings of critical equipment and support systems maintained,Basic Principles of GMP,Current drawings of critical equipment Verify against qualification protocol and report, as well as suppliers manual Check if
8、 in accordance with drawing, or changes (change control) Verify critical components installed, e.g. filters, control and monitoring devices,Basic Principles of GMP,What are the questions you can ask about this piece of equipment?,Basic Principles of GMP,And for this one?,Basic Principles of GMP,What
9、 do these labels indicate for this piece of equipment? Do you notice any GMP non-compliance?,Basic Principles of GMP,Basic Principles of GMP,What are some of the key questions you can ask about the blender?,Basic Principles of GMP,Transfer of material to the compression machine through a closed syst
10、em is preferred to prevent possible contamination,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?,Basic Principles of
11、GMP,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?,Basic Principles of GMP,Dont forget the packaging lines!,Equipment,Control laboratory equipment Equipment and instruments suita
12、ble for the tests to be performed Defective equipment removed labelled,13.7, 13.10,13.6, 13.8,Equipment,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
13、 Washing and cleaning manual automated (Clean in place (CIP), Steam in place (SIP),Equipment,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?,Basic Principles of GMP,Equipment,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,
