Basic Principles of GMP Equipment 13 Module 10

Basic Principles of GMP Equipment 13 Module 10 | January 2006 Slide 1 of 26 STOP

Equipment Objectives l To review the requirements for equipment ä selection ä design ä use ä maintenance l To discuss problems related to issues around selected items of equipment Module 10 | January 2006 Slide 2 of 26 STOP

Equipment Principle l Equipment must be ä located ä designed ä constructed ä adapted ä maintained to suit the operations to be carried out 13. 1 Module 10 | January 2006 Slide 3 of 26 STOP

Basic Principles of GMP l What does ä location ä design ä construction ä adaptation ä maintenance ä cleaning ä calibration ä … mean in practice? Module 10 | January 2006 Slide 4 of 26 STOP

Equipment Principles l Equipment layout and design must aim: ä to minimize risks of error ä to permit effective cleaning and maintenance l To avoid: ä cross-contamination, dust and dirt build-up ä any adverse effect on the quality of products l Equipment must be installed to: ä minimize risks of error ä minimize risks of contamination Module 10 | January 2006 Slide 5 of 26 STOP 13. 1, 13. 2

Equipment Pipes l Fixed pipework ä clearly labelled ä indicate contents and direction of flow l Service pipings and devices ä adequately marked ä non-interchangeable connections or adaptors for dangerous gases and liquids 13. 3, 13. 4 Module 10 | January 2006 Slide 6 of 26 STOP

Basic Principles of GMP Contents and direction of flow indicated l e. g. water lines, equipment components, air-handling systems Module 10 | January 2006 Slide 7 of 26 STOP

Equipment Balances and Measuring Equipment l Appropriate range and precision available l In production and quality control l Calibrated ä scheduled basis ä checks ä records maintained 13. 5 Module 10 | January 2006 Slide 8 of 26 STOP

Equipment Production equipment l Appropriate design ä easily and thoroughly cleaned on a scheduled basis ä procedures and records l No hazard to the products ä contact parts of suitable non-reactive materials ä non additive and ä not absorptive l Defective equipment ä removed, or ä labelled to prevent use 13. 9, 13. 10 Module 10 | January 2006 Slide 9 of 26 STOP

Equipment Production equipment l Closed equipment used when possible l Open equipment, or when equipment opened, precautions taken to prevent contamination l Non-dedicated equipment cleaned according to validated cleaning procedures between different products l Current drawings of critical equipment and support systems maintained 13. 11 – 13. 13 Module 10 | January 2006 Slide 10 of 26 STOP

Basic Principles of GMP Current drawings of critical equipment l Verify against qualification protocol and report, as well as supplier's manual l Check if in accordance with drawing, or changes (change control) l Verify critical components installed, e. g. filters, control and monitoring devices Module 10 | January 2006 Slide 11 of 26 STOP

Basic Principles of GMP l What are the questions you can ask about this piece of equipment? Module 10 | January 2006 Slide 12 of 26 STOP

Basic Principles of GMP l And for this one? Module 10 | January 2006 Slide 13 of 26 STOP

Basic Principles of GMP l What do these labels indicate for this piece of equipment? l Do you notice any GMP non -compliance? Module 10 | January 2006 Slide 14 of 26 STOP

Basic Principles of GMP Module 10 | January 2006 Slide 15 of 26 STOP

Basic Principles of GMP l What are some of the key questions you can ask about the blender? Module 10 | January 2006 Slide 16 of 26 STOP

Basic Principles of GMP l Transfer of material to the compression machine through a closed system is preferred to prevent possible contamination Module 10 | January 2006 Slide 17 of 26 STOP

Basic Principles of GMP l Remember to look at punches and dies l Are there specifications for these? l How are they cleaned, stored, issued for use and returned to storage? l Are they in a good condition and checked at regular intervals? Module 10 | January 2006 Slide 18 of 26 STOP

Basic Principles of GMP Module 10 | January 2006 Slide 19 of 26 STOP

Basic Principles of GMP Coating of tablets l Is qualification of a coating machine necessary? l If so, what has to be done? l What about maintenance? l And cleaning validation? Module 10 | January 2006 Slide 20 of 26 STOP

Basic Principles of GMP l Don't forget the packaging lines! Module 10 | January 2006 Slide 21 of 26 STOP

Equipment Control laboratory equipment l Equipment and instruments ä suitable for the tests to be performed l Defective equipment ä removed ä labelled 13. 7, 13. 10 Module 10 | January 2006 Slide 22 of 26 STOP

Equipment Washing, cleaning and drying l Equipment used for washing and drying – not the source of contamination l Equipment design should promote easy cleaning l Cleaning on scheduled basis, procedures and records l Washing and cleaning ä manual ä automated (Clean in place (CIP), Steam in place (SIP)) 13. 6, 13. 8 Module 10 | January 2006 Slide 23 of 26 STOP

Equipment Group Session l For the given type of equipment ä What would your concerns be in relation to the manufacture of products, when inspecting this particular piece of equipment? ä What are the signs of poor practice in cleaning, operation and maintenance? Module 10 | January 2006 Slide 24 of 26 STOP

Basic Principles of GMP Module 10 | January 2006 Slide 25 of 26 STOP

Equipment Possible Issues l Poor design l Lack of safety l Poor quality finishes l Lack of cleaning l Lack of maintenance l No usage log or record l Use of inappropriate weighing equipment l Open-plan location of compressing machines Module 10 | January 2006 Slide 26 of 26 STOP