Change table: Manufacturing changes - finished product

Version 2.4, 4 December 2017

Last updated

4 December 2017

Manufacturing changes to the finished product, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codes	Manufacturing changes - finished product	Status codes	Assurance codes	Application level	Applicable section of the Act
MMA	Addition of a manufacturer (includes site of manufacture), other than for sterile products where MSS or MST applies	N See notifications guidance	5	CN	9D(2C)
MMD	Deletion of a manufacturer (includes site of manufacture).	N See notifications guidance	5	CN	9D(2C)
AMS	Addition of steps of manufacture, other than for sterile products where MSS or MST applies	N See notifications guidance	5	CN	9D(2C)
MSD	Deletion of steps of manufacture.	N See notifications guidance	5	CN	9D(2C)
MPT	Manufacturing process: tightening of in-process limits and/or introduction of an additional in-process control	O
MPR	Manufacturing process other than for 'higher risk' OTC products (see MPH or MPD) or for sterile products (see MSS or MST). See also MPT	SAR	5, 13	C1	9D(3)
MPH	Manufacturing process for the following 'higher risk' OTC products: microdose products (solid oral dosage forms where the active ingredient is present in an amount of less than 2mg or 2% w/w of the dosage form) products with a sustained release characteristic (not including enteric coated products) metered dose inhalers nasal corticosteroids where the changes have been demonstrated, for the product, to be equivalent to or superior to the approved manufacturing process	SAR	5, 13	C1	9D(3)
MPD	Manufacturing process for the following 'higher risk' OTC products: microdose products (solid oral dosage forms where the active ingredient is present in an amount of less than 2mg or 2% w/w of the dosage form) products with a sustained release characteristic (not including enteric coated products) metered dose inhalers nasal corticosteroids except where MPH applies. See also 'Manufacturing process validation' in ARGOM Appendix 2, section 5.2.1	A	5, 13	C2	9D(3)
MUP	GMP clearance number update only. Involves no other change to the product	SAR (fee exempt)	5	C1	9D(3)
MSS	For a sterile product: Addition of a manufacturer (includes site of manufacture) involving only one or more of the following steps: release for supply, secondary packaging or testing [chemical and physical or microbial] Addition of steps of manufacture involving only one or more of the following steps: release for supply, secondary packaging or testing [chemical and physical or microbial]	N See notifications guidance	5, 9	CN	9D(2C)
MST	For a sterile product: Addition of a manufacturer (includes site of manufacture) other than where MSS applies Addition of steps of manufacture other than where MSS applies Change in the manufacturing process (see also 'Manufacturing process validation' in ARGOM Appendix 2, section 5.2.1)	A	5	C2	9D(3)