Change table: Quality control changes - starting material specifications

Version 2.4, 4 December 2017

Last updated

4 December 2017

Changes to the quality controls for the starting materials specifications, 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	Quality control changes - starting material specifications	Status codes	Assurance codes	Application level	Applicable section of the Act
QSX	Specification limits or requirements - more restrictive	O
QSE	Specification limits or requirements - less restrictive (except where QSA applies); where any supporting data provided consist only of module 3 (and not module 4) data.	A	5, 27	C2	9D(3)
QSF	Specification limits or requirements - less restrictive; where supporting module 4 data or a justification for not providing the supporting data is required. For example, a sponsor wishes to widen the limits for a related substance from the level normally applied of NMT 1% to NMT 3.5% and justifies the widening of the specification on the basis of a dossier which includes preclinical studies and published toxicology papers.	A	5, 27	C3	9D(3)
QST	Addition of an extra test	O
QSU	Deletion of an existing test where any supporting data provided consist only of module 3 data.	A	5, 27	C2	9D(3)
QSD	Deletion of an existing test where supporting module 4 data or a justification for not providing the supporting data is required. For example, a sponsor wishes to delete a particular test for a substance that would normally be required but provides supporting data in the form of preclinical studies which support the sponsor's case for removal of the test from the specifications.	A	5, 27	C3	9D(3)
QSA	Changes to the starting material specifications (test, test methods and limits/requirements) to comply with a standard as defined in the Therapeutic Goods Act 1989 (e.g. the BP or a Therapeutic Goods Order). No non-pharmacopoeial test/requirement is concurrently deleted from the specification e.g. a specification for particle size distribution.	O
QSB	Analytical method (does not include changes to test limits/requirements) - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity)	O
QSC	Analytical method - other than as specified in change QSA or QSB	A	5	C2	9D(3)
QSM	Manufacturer of starting material (specifications unchanged)	O
QSS	Supplier of starting material	O
QSP	Change from one 'default standard' (as defined in the Therapeutic Goods Act 1989) to another (e.g. BP to USP) or from a 'company' or 'in-house' specification to a pharmacopoeial specification. This includes deletion of the existing pharmacopoeial tests and limits This does not include deletion of, or a change to, any current additional non-pharmacopoeial specifications e.g. particle size distribution.	N See notifications guidance	5	CN	9D(2C)