Australian Regulatory Guidelines for

Prescription Medicines

June 2004
Australian Regulatory Guidelines for Prescription Medicines

APPENDIX 7: CERTIFIED PRODUCT DETAILS

Certified Product Details (CPD) are a summary of the formulation, quality control and
shelf life for a product. They specify test methods and limits for results. The CPD
are used by the TGA Laboratories (TGAL) when testing products and avoid the need
to search through voluminous dossiers and files for the information concerned.

The CPD are prepared by sponsors at the request of the Therapeutic Goods
Administration (TGA).

The CPD consist of a covering page (which contains information that will be used by
TGA for indexing purposes), and details of packaging, formulation, release and
expiry specifications, testing methodology, the method of sterilisation, shelf life and
storage conditions.

Testing methodology should be in sufficient detail to allow duplication of the tests in

TGA Laboratories. A list of specialised instrumentation should be included such as
an unusual HPLC column or a non-British Pharmacopoeia (BP)/United States
Pharmacopeia (USP) dissolution apparatus. In descriptions of sterility test methods,
details should be included of how antimicrobial activity is neutralised.

A proforma for the CPD is available on the TGA web site1.

The CPD should be signed by a senior representative of the Australian product

sponsor. The signature signifies that the individual takes responsibility for the
accuracy of the contents.

Where quality data have been evaluated by, or for the DSEB, the CPD must
accurately reflect the submitted data as modified by any changes subsequently
agreed with the sponsor.

Each dosage form should have a separate CPD. Different strengths and packaging
may appear in the same CPD but any differences should be made clear, for
example, different formulations and/or different tablet weight for different strengths.
A separate set of specifications should be provided for each strength.

The CPD is not a means of introducing changes to the quality data. Because the
CPD are not necessarily evaluated on receipt, sponsors should not assume that
information submitted in the CPD has been approved. Similarly use of the CPD
methodology by TGAL does not imply approval of the method for registration
purposes because other considerations may be relevant to approval, such as
correlation of a dissolution or particle size test and limit with in vivo data.

The CPD will normally be sought towards the end of the evaluation of the quality
data (Module 3) for Category 1 and 2 applications. Submission of the CPD is
normally upon request by TGA, rather than in the initial submission, because there
are usually changes to make following the evaluation, but sponsors sometimes
submit draft CPD of their own volition.

1
http://www.tga.gov.au

Appendix 7 - page 1 of 2
Australian Regulatory Guidelines for Prescription Medicines - Certified Product Details

Once the CPD have been requested, it is in the sponsor’s interests to provide them
in a timely manner for checking by TGA evaluators so that an agreed version is
available for any TGAL testing that is deemed necessary.

Updated CPD will normally be sought following approval of a Category 3 application

to change finished product specifications (including a change to test methods and/or
limits for results), and/or a self-assessable change is made that affects the finished
product specifications (see also N8 of Appendix 12).

Updated CPD will not normally be sought for changes to formulation, particle size of
the active ingredient(s), pack size, container type, sterilisation method, shelf life or
storage conditions, even though these items are normally included in the CPD.

When updated CPD are supplied, the sponsor need not provide a new copy of
testing methodology if these details have not changed. The first copy of the CPD
must include the testing methodology. When there are several strengths of a
product, a single CPD document is preferred.

The CPD may be sought in other circumstances at the discretion of the DSEB or
TGAL, for example, when a grandfathered product that has not previously been
evaluated comes to the TGA’s attention for some reason, perhaps because a
complaint has been made.

TGAL may request the CPD when a sample is to be tested if they do not already
hold a copy. When received or requested in conjunction with the evaluation of an
application to register a product, the CPD will normally be checked by the evaluator
of the quality data.

When received in response to a request from the TGA Laboratory, the CPD will not
normally be checked immediately. However, insofar as the TGA Laboratory uses
company test procedures, a laboratory assessment may occur and questions may
arise.

DSEB and TGAL reserve the right to check or recheck the CPD at any stage at their
discretion. Any deficiencies may lead to questions to the sponsor.

Note that an exemption under Section 14 of the Therapeutic Goods Act 1989 may be
required where specified test procedures or requirements do not conform to an
applicable standard (for example, a departure from British Pharmacopoeial
requirements or an applicable Therapeutic Goods Order)

Appendix 7 - page 2 of 2