WHO - PSM Equipment P harmaceutical Quality, Good manufacturing Practice & Bioequivalence Kiev, Ukraine October 2005 Maija Hietava M.Sci.Pharm Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: Fax: World Health Organization Basic Principles of GMP Part One, 13
WHO - PSM Equipment Objectives l To review the requirements for equipment selection, design, use and maintenance l To discuss problems related to issues around selected items of equipment
WHO - PSM Equipment Principle l Equipment must be ä located ä designed ä constructed ä adapted ä maintained to suit their intended use Part One, 13.1
WHO - PSM Equipment Principle l Equipment layout and design must aim: ä to minimize risks of error ä to permit effective cleaning ä to permit effective maintenance l And to avoid: ä cross-contamination ä 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 Part One, 13.1 – 13.2
WHO - PSM Part One,13.3–13.4 Equipment Pipes and pipings l Fixed pipework: ä clearly labelled ä indicate contents ä direction of flow l Service pipings ä adequately marked ä non-interchangeable connections or adaptors l Dangerous gases and liquids
WHO - PSM Part One, 13.5 Equipment Balances and Measuring Equipment l Appropriate range l Precision l Available to: ä production ä quality control l Calibrated ä scheduled basis ä checks ä records maintained
WHO - PSM Part One, 13.6, 13.9–13.10 Equipment Production equipment l Design ä easily and thoroughly cleaned ä scheduled basis l Location l Maintenance l No hazard to the products ä suitable non-reactive materials ä non additive ä not absorptive l Defective equipment ä removed ä labelled
WHO - PSM Equipment Control laboratory equipment l Equipment and instruments: ä suitable for the tests to be performed l Defective equipment ä removed ä labelled Part One, 13.7 and 13.10
WHO - PSM Part One, 13.6, 13.8 and Equipment Washing and Cleaning l Design promotes easy cleaning l On scheduled basis l Prevent cross-contamination: Validated cleaning methods l Washing and cleaning equipment: ä Manual ä Automated (Clean in place (CIP), Steam in place (SIP)) ä Not the source of contamination
WHO - PSM Equipment Possible Issues l Poor design l Lack of safety l Poor quality finishes l Lack of cleaning l Lack of maintenance l Lack of calibration l No usage log or record l Use of inappropriate oil during maintenance l Open-plan location of compressing machines l Numbering, cleaning and maintenance of punches