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Changing an OTC medicine: using the Changes Tables

Version 2.4, 4 December 2017

4 December 2017

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Change table: Quality control changes - finished product specifications

Changes to the quality controls for finished product 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 - finished product specifications Status codes Assurance codes Application level Applicable section of the Act
QFX Specification limits or requirements - more restrictive O
QFE Specification limits or requirements - less restrictive (except where QFA applies); where any supporting data provided consist only of module 3 (and not module 4) data. A 5, 27 C2 9D(3)
QFF Specification limits or requirements - less restrictive; where supporting module 4 (preclinical / toxicological) 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)
QFT Addition of an extra test O
QFU Deletion of an existing test where any supporting data provided consist only of module 3 data A 5, 27 C2 9D(3)
QFD 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 product 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)
QFI Frequency of testing - increase O
QFR Frequency of testing - reduction A 5, 27 C2 9D(3)
QFA Changes to the finished product 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), other than as specified in change MST. No non-pharmacopoeial test / requirement is concurrently deleted from the specification. O
QFB Analytical method (does not include changes to tests and limits/requirements) - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and / or specificity), other than as specified in change MST O
QFC Analytical method - other than as specified in change QFA, QFB or MST A 5 C2 9D(3)
QFP

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 involve deletion of, or a change to, any current additional non-pharmacopoeial specifications e.g. residual solvents in the finished product or friability

N

See notifications guidance

5, 27 CN 9D(2C)

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