8General requirements

8 General requirements

(1) FMT products must only be manufactured using stool that has been collected from an accepted donor. (2) The procedures and controls used in the manufacture of FMT products must: (a) be clearly defined and documented in a systematic way in the form of written policies and standard operating procedures; and (b) ensure that the FMT products are safe for use; and (c) ensure the FMT products are manufactured consistently and comply with the specifications for the products; and (d) be systematically reviewed and, if appropriate, modified. (3) The procedures must ensure the traceability of stool used in the manufacture of FMT products from the collection of the stool to the supply of the products. (4) The critical materials used in the manufacture of FMT products must not adversely affect the quality or safety of the products. (5) The personnel involved in the manufacture of FMT products must be appropriately qualified and competent to manufacture FMT products. (6) The test methods used in the manufacture of FMT products must be validated or verified. (7) The equipment and reagents used in the manufacture of FMT products must be qualified. (8) A system must be established and maintained to: (a) handle complaints made or concerns raised by any person in relation to the manufacture of FMT products; and (b) ensure process and quality improvement functions and activities are carried out regularly.