Approval of overseas manufacturers (GMP preclearance) - dosage form codes and description

Sponsors who have recently submitted an application for an assessment of GMP evidence for an overseas manufacturer will have noticed a change to the assessment letter of GMP compliance for overseas manufacturers issued by the GMP Audit & Licensing Section. Alongside the Dosage Forms, an abbreviated code and full description of that Code are now specified in the letter. The current database has been modified to now report the Dosage Form Codes/description.

To ensure that your assessment application is not further delayed, sponsors are asked to ensure that Section 4 - Product Details, of the Overseas Manufacturer GMP Preclearance Request Form, is filled out according to the Dosage Form Code/s and corresponding description. A list of the Dosage Form Codes can now be found on the TGA's SIME website <https://www.ebs.tga.gov.au>. Click on the Code Tables icon then on Dosage Forms.

The Overseas Manufacturer GMP Preclearance Request form has been revised to reflect this change.

Manufacture of herbal therapeutic goods - starting materials

Manufacturers of herbal starting materials are advised of the importance of effective and specific identification testing of herbal materials using authenticated herbal reference materials as comparisons.

Under Australian GMP requirements, manufacturers are advised that it is their responsibility to carry out effective and specific identification testing of herbal starting materials, against authenticated herbal reference materials or equivalent, prior to their use in manufacture. The Therapeutic Goods Administration considers that this will be most effectively done using chromatographic techniques such as TLC or HPLC.

TGA GMP auditors will be focussing on this issue in upcoming audits. Lack of specific identification testing of herbal starting materials together with the absence of authenticated reference materials could constitute a critical nonconformity and may result in further action being taken in relation to the manufacturing licence issued to the company.

New manufacturing principle - Australian Code of Good Manufacturing Practice for Medicinal Products

A new Manufacturing Principle was gazetted on 28 August 2002. The Australian Code of Good Manufacturing Practice for Medicinal Products <http://www.tga.gov.au/docs/html/gmpcodau.htm> (16 August 2002), replaces the Australian Code of Good Manufacturing Practice for Therapeutic Goods - Medicinal Products (August 1990), the Australian Code of Good Manufacturing Practice for Therapeutic Goods - Medicinal Gases (July 1992) and the Investigational Medicinal Products Code of GMP (Annex 13, EC GMP Guide, 1997).

The new Code is based entirely on the international standard Guide to Good Manufacturing Practice for Medicinal Products, version PH 1/97 (Rev. 3), 15 January 2002, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

There will be a transition period of twelve months, during which time either the 16 August 2002 version or the August 1990 version of the Australian Code of Good Manufacturing Practice for Medicinal Products may be used.

It is intended that by the end of August 2003 the Therapeutic Goods Administration will use only the new Australian Code of Good Manufacturing Practice for Medicinal Products as the basis for the licensing of all Australian manufacturers of medicinal products.