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1 Equipment must be located, designed, constructed, adapted and adapted to the operations. The layout and design of the equipment must aim to minimize the risk of malfunctions and allow effective cleaning and maintenance without creating cross-contamination, dust or dirt and, in general, without adversely affecting quality. product
2 Equipment should be installed in such a way as to minimize the risk of malfunction or contamination.
3 Specific pipework should be clearly labeled to indicate the contents and, where applicable, direction of flow.
4 All service piping and devices should be adequately marked and special attention should be paid to the provision of non-interchangeable connections or adapters for hazardous gases and liquids.
5 Balances and other measuring equipment of a suitable range and accuracy should be available for production and control operations and should be calibrated on a scheduled basis.
6 Production equipment should be thoroughly cleaned on a scheduled basis.
7 Laboratory equipment and instruments should be suitable for the test method adopted.
8 Washing, cleaning and drying equipment should be selected and used so as not to be a source of contamination.
9 Manufacturing equipment shall not present any hazard to the Products. Parts of production equipment that come into contact with the product should not be reactive, additive or absorbent to an extent that affects the quality of the product.
10 Defective equipment should be removed from production and quality control areas. If this is not possible, it should be clearly labeled as defective to prevent use.
11 Closed appliances should be used whenever appropriate. Where open equipment is used or equipment is opened, precautions should be taken to minimize contamination.
12 Non-dedicated equipment should be cleaned according to valid cleaning procedures between different pharmaceutical product manufactures to prevent cross-contamination.
13 Current drawings of critical equipment and support systems should be maintained.
