5.2 Is each piece of equipment in contact with the product made of suitable materials (e.g. not reactive, additive, or absorptive and will not adversely affect the product)?

5.3 Is the entire equipment in contact with products drained and capped after the operation, according to written procedures?

5.4 Is each piece of equipment (specifically auxiliary equipment) designed and used in a manner that minimizes the potential for contamination of the product with lubricants, coolants, metal fragments, or other extraneous materials e.g. from pressurised air?

5.5 Is defective equipment taken out of service, (e.g. either removed, disposed of or status labelled)?

5.6 Is the entire equipment in contact with products located in clean areas?

5.7 Are there procedures in place to ensure compatibility of equipment with the products?

5.8 Is pipe work (including devices) in contact with product labelled with direction of flow, where applicable (including name of material)?

5.9 Is the entire equipment in contact with products clearly labelled?

5.10 Are there a sufficient number of balances and measuring devices available which are necessary for the operation carried out?

5.11 Is there evidence (records) of regular (quality-critical) equipment calibration?

5.12 Is there a process in place to consider if deviations of calibration of quality critical equipment have had an impact on the quality of product since the last successful calibration?

5.13 Do operation procedures detail how each piece of equipment critical to the processes should be used?

5.14 Is the maintenance policy covered by written procedures?

5.15 Is there a Preventative Maintenance Plan?

5.16 Are maintenance records available?

5.17 Is there a process in place for monitoring and approving the quality of maintenance?

5.18 Is each piece of equipment in contact with the product cleaned and maintained according to written procedures?

5.19 If product exposure to, or contamination with, lubricants or coolants is possible, are these materials suitable for use in food applications?

5.20 Is appropriate cleaning equipment selected to avoid contamination of products?

5.21 Is each piece of equipment in contact with the product dedicated to the product or effectively cleaned according to a written procedure?

5.22 Are all pieces of equipment coming in contact with the product, compatible with the product and in compliance with legal requirements?

5.23 (If equipment is not dedicated) is the equipment only used for Food, Cosmetic, and/or Pharma grade products?

5.24 Is there an effective cleaning procedure in place, whenever product change is necessary?

5.25 Is controlled testing equipment available?

5.26 Is all the equipment in contact with products dedicated or are validated cleaning procedures applied in case of product changes?

5.27 Is cleaning efficiency of non-dedicated equipment verified?