5.1 Equipment must be located, designed, constructed, adapted, used and maintained to suit the operations to be carried out. Defective equipment should not be used, and should either be removed or labelled as defective. Equipment should be disposed of in such a way as to prevent any misuse.
5.2 The layout, design and use of equipment must aim to minimize the risk of errors and to permit effective cleaning and maintenance to avoid cross-contamination, build-up of dust or dirt and any adverse effect on the quality of materials.
5.3 Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow.
5.4 All services, piping and devices should be adequately marked and special attention paid to the provision of non-interchangeable connections or adaptors for dangerous gases, liquids and other materials.
5.5 Balances and other measuring equipment of an appropriate range and precision should be available and should be calibrated on a scheduled basis.
5.6 Procedures should be in place for the operation and maintenance of equipment. Lubricants and other materials used on surfaces that come into direct contact with the materials should be of the appropriate grade, e.g. food-grade oil.
5.7 Washing and cleaning equipment should be chosen and used such that it cannot be a source of contamination.
5.8 Dedicated equipment should be used where possible when handling and/or processing pharmaceutical starting materials. Where non-dedicated equipment is used, cleaning validation should be performed.