(2003; 148 pages)
13.1 Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the quality of products.
13.2 Equipment should be installed in such a way as to minimize any risk of error or of contamination.
13.3 Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow.
13.4 All service pipings and devices should be adequately marked and special attention paid to the provision of non-interchangeable connections or adaptors for dangerous gases and liquids.
13.5 Balances and other measuring equipment of an appropriate range and precision should be available for production and control operations and should be calibrated on a scheduled basis.
13.6 Production equipment should be thoroughly cleaned on a scheduled basis.
13.7 Laboratory equipment and instruments should be suited to the testing procedures undertaken.
13.8 Washing, cleaning and drying equipment should be chosen and used so as not to be a source of contamination.
13.9 Production equipment should not present any hazard to the products. The parts of the production equipment that come into contact with the product must not be reactive, additive, or absorptive to an extent that would affect the quality of the product.
13.10 Defective equipment should be removed from production and quality control areas. If this is not possible, it should be clearly labelled as defective to prevent use.
13.11 Closed equipment should be used whenever appropriate. Where open equipment is used or equipment is opened, precautions should be taken to minimize contamination.
13.12 Non-dedicated equipment should be cleaned according to validated cleaning procedures between production of different pharmaceutical products to prevent cross-contamination.
13.13 Current drawings of critical equipment and support systems should be maintained.