Australian regulatory guidelines for prescription medicines Appendix 7: Certified product details

June 2004

Therapeutic Goods Administration

About the Therapeutic Goods Administration (TGA) The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. To report a problem with a medicine or medical device, please see the information on the TGA website.

Copyright© Commonwealth of Australia 2004This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney General’s Department, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca Australian regulatory guidelines for prescription medicines – Appendix 7June 2004 Page 2 of 5

Therapeutic Goods Administration

Appendix 7: Certified product detailsCertified 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.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).1http://www.tga.gov.au

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Therapeutic Goods Administration

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)

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Therapeutic Goods AdministrationPO Box 100 Woden ACT 2606 AustraliaEmail: info@tga.gov.au Phone: 02 6232 8444 Fax: 02 6232 8605www.tga.gov.auReference/Publication #