Document ID: chunk:federal_register_of_legislation:F2024C00464:schedule:1:p1
Version: federal_register_of_legislation:F2024C00464
Segment Type: schedule
Provision Reference: sch 1 (pt 1/4)
Character Range: 10138–13035

Schedule 1—Manufacturing Principles
Note: See sections 6 and 7.

Part 1—Therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.
 (1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the PIC/S Guide to GMP.
 (2) Where the PIC/S Guide to GMP provides that a procedure or requirement 'should' be followed, the manufacture of therapeutic goods must follow the procedure or requirement in order to comply with the PIC/S Guide to GMP unless, in relation to that particular procedure or requirement:
 (a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:
 (i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and
 (ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and
 (iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP; or
 (b) where an alternative to the procedure or requirement set out in the PIC/S Guide to GMP has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:
 (i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person or will, or could, potentially have the effect of causing or contributing to such harm or injury; and
 (ii) the alternative will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and
 (iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP.
 (3) The reference to "applicable procedures and requirements" in subsection (1) does not include a procedure or requirement specified in an Annex to the PIC/S Guide to GMP that is identified as voluntary.

Part 2—Therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs
 (1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the Australian Code of Good Manufacturing Practice.
 (2) Where the Australian Code of Good Manufacturing Practice provides that a procedure or requirement 'should' be followed, the manufacture of therapeutic goods in Australia must follow the procedure or requirement in order to comply with the Australian Code of Good Manufacturing Practice.
 (3) An application for a licence to carry out steps in the manufacture of blood,