TGA News Issue 38 (July 2002) - Manufacturing
Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.
Addition to GMP Standard of Overseas Manufacturers (12th Edition)
The following amendment has been made to the GMP Standard of Overseas Manufacturers (12th Edition).
Where an overseas manufacturer changes its name, evidence of the name change can be in the form of:
An original letter from the health authority in the manufacturer's country (being a country that Australia recognises as having a standard of GMP inspections at least equivalent to that of Australia) to certify that the manufacturer's name has changed from XXX to YYY; OR
An original declaration from the manufacturer that its name has changed from XXX to YYY, authenticated by the health authority of that country (being a country that Australia recognises as having a standard of GMP inspections at least equivalent to that of Australia).
Where GMP evidence is not current or is about to expire, new GMP evidence should also be submitted.
Adoption of PIC/S GMP Guide as a manufacturing principle
On 16 April 2002, the Therapeutic Goods Committee (TGC) recommended that the current Australian Code of Good Manufacturing Practice (GMP) for Medicinal Products (August 1990 edition) be replaced with the current Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP Guide for Medicinal Products (15 January 2002 edition).
The PIC/S GMP Guide is virtually identical to the European Community (EC) GMP Guide. The main difference being the use of the term "authorised person" in the PIC/S Guide and "Qualified Person" in the EC GMP Guide.
Gazettal of the PIC/S GMP Guide as a Manufacturing Principle is expected to take place on 1 July 2002. A transition period of 12 months will apply from the date of gazettal of the PIC/S document.
Copies of the January 2002 PIC/S GMP Guide for Medicinal Products may be obtained from the PIC/S website <http://www.picscheme.org>.
The TGC also recommended that educational seminars on the adoption of the PIC/S document should be held for industry. The first of these seminars will be held in Sydney on 28 August 2002 (jointly arranged by the Royal Australian Chemical Institute (RACI), Australian Pharmaceutical Manufacturers Association (APMA) and the Australian Self Medication Industry (ASMI). A second seminar will be held in Brisbane on 2 September 2002 (jointly arranged by the Australian Society of Cosmetic Chemists (ASCC) and the International Society for Pharmaceutical Engineering (ISPE). A third seminar will be held in Melbourne on 5 September 2002 (jointly arranged by the International Association for Pharmaceutical Science and Technology (PDA) and ISPE). The TGA is looking into the possibility of holding further seminars in Adelaide and Perth.
Details of the venues and programs for these seminars will be published by the relevant organisations during June-July 2002.
Form to request GMP certificates
The TGA has been issuing GMP certificates to manufacturers for many years, with the number of requests increasing steadily as a result of increasing exports of therapeutic goods.
The Good Manufacturing Practice Audit and Licensing Section (GMPALS) recently introduced a standard form for use by sponsors/manufacturers when requesting GMP certificates. The form is designed to streamline the process of requesting GMP certificates by providing the sponsor/manufacturer with a selection of certificates to request and their cost, as well as the option to pay by cheque or credit card.
The form requires the applicant to complete details on manufacturer name and site address, product type and dosage form and steps of manufacture. This information is necessary for GMPALS to issue the certificate expeditiously.
As each GMP certificate relates to a specific manufacturing site audited by the TGA, it is important that the manufacturer is aware of the expiry date indicated on the certificate to ensure that a re-audit is undertaken prior to this expiry date.
- Request form for GMP or Quality Systems certificates <http://www.tga.gov.au/docs/html/forms/gmpcert.htm>
New list of licensed Australian manufacturers
The April 2002 edition of the Australian Manufacturers Licensed to Manufacture Therapeutic Goods has been published. The document contains details of licensed manufacturers grouped under four main sections:
- medicine manufacturers
- specialised contract single step/product manufacturers
- medical device manufacturers
- manufacturers not elsewhere classified.
As the information contained within the document is subject to frequent change, the TGA urges sponsors and manufacturers to contact the GMP Section on 02 6232 8629 prior to making decisions based on the information in the document.