Drug Standards and Best Practice

Links to information about drug manufacturing standards, benchmarking and best practice, including codes of conduct, and international agreements.

 

Updated April 2008

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40 Resources Found
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Title:   Consolidated advisory statement requirements for medicine labels - Consultation document
Publisher:   Australian Government Department of Health and Ageing
Description:   The consultation document Consolidated Advisory Statement Requirements for Medicine Labels (CASRML) consolidates all Australian label advisory statement requirements for medicines in one place.
Date:   May 2006
Title:   Expert Committee on Complementary Medicines in the Health System
Publisher:   Australian Government Department of Health and Ageing
Description:   In May 2003, to reassure the public and maintain confidence in Australia's reputation as a supplier of high quality and safe medicines, the Australian Government established the Expert Committee on Complementary Medicines in the Health System.
Date:   Oct 2003
Title:   Chemicals and public health - an information brochure on the assessment of toxicity
Publisher:   Australian Government Department of Health and Ageing
Description:   This brochure explains how public health is protected through the study of the toxicity of chemicals and their potential to cause adverse effects on humans; and how this information is used in the development of exposure standards to ensure that health risks are minimised.
Date:   Dec 2004
Title:   A guide to labelling drugs and poisons
Publisher:   Australian Government Department of Health and Ageing
Description:   This guide has been prepared to assist manufacturers and packers of poisons to draft labels which comply with the harmonised requirements as they exist on 1 July 2000.
Date:   Oct 2007
Title:   Medicine label advisory statements consultation document
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA's Review of the Labelling Requirements for Medicines recommended that warning and advisory statements from various sources be consolidated into a single document. This consultation document proposes a method for implementing that recommendation and a process for ensuring the resulting document is maintained in an efficient and effective manner. The closing date for responses was Friday 13 December 2002.
Date:   Oct 2002
Title:   Australian Code of Good Manufacturing Practice for Medicinal Products
Publisher:   Australian Government Department of Health and Ageing
Description:   The new Australian Code of GMP for Medicinal Products, dated 16 August 2002, replaces the Australian Code of GMP for Medicinal Products dated August 1990.
Date:   Oct 2002
Title:   Classification of Deficiencies (medicinal product manufacturers)
Publisher:   Australian Government Department of Health and Ageing
Description:   The GMP Audit and Licensing Section now classifies deficiencies (previously referred to as nonconformities) observed during GMP audits of medicinal product manufacturers as critical, major and other.
Date:   Aug 2007
Title:   Audit of medicine manufacturers
Publisher:   Australian Government Department of Health and Ageing
Description:   With certain exceptions, manufacturers of therapeutic goods in Australia are required under the Therapeutic Goods Act 1989 to hold a licence. To obtain a licence to manufacture therapeutic goods, a manufacturer must demonstrate compliance with manufacturing principles.
Date:   Oct 2003
Title:   Office of Chemical Safety
Publisher:   Australian Government Department of Health and Ageing
Description:   The Office of Chemical Safety provides advice on potential public health risks posed by chemicals used in the community.
Date:   Jan 2008
Title:   TGA - Therapeutic Goods Administration
Publisher:   Australian Government Department of Health and Ageing
Description:   Home page of Therapeutic Goods Administration (TGA). TGA is Australia's regulatory agency for medical drugs and devices.
Date:   Dec 2008
Title:   The use of antibiotics in food-producing animals: antibiotic-resistant bacteria in animals and humans
Publisher:   Commonwealth Department of Health and Aged Care
Description:   Antibiotics are used to treat and prevent infectious bacterial diseases in humans and in domestic and food-producing animals. If bacteria become resistant, the antibiotics become ineffective.
Date:   Oct 1999
Title:   Australia-Singapore MRA on conformity assessment
Publisher:   Australian Government Department of Health and Ageing
Description:   A mutual recognition agreement (MRA) on conformity assessment between Australia and Singapore was signed in Canberra on 26 February 2001.
Date:   Jul 2006
Title:   Australia - European Free Trade Association mutual recognition agreement (EFTA-MRA)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Australia-EFTA Mutual Recognition Agreement (MRA) is an Agreement of treaty status, which has been negotiated on terms, which are almost identical to the Australia-European Community MRA on conformity assessment (EC-MRA) with some minor variations.
Date:   Jul 2006
Title:   Australia - European Community mutual recognition agreement (EC-MRA)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Mutual Recognition Agreement (MRA) on standards and conformity assessment between Australia and the European Community (EC) was signed in Canberra on 24 June 1998 and came into effect on 1 January 1999.
Date:   Jul 2006
Title:   International activities, agreements and information
Publisher:   Australian Government Department of Health and Ageing
Description:   Links to information on international activities, agreements and international regulatory agencies
Date:   Jan 2008
Title:   Educational outreach visits: effects on professional practice and health care outcomes
Publisher:   John Wiley and Sons, Ltd. for The Cochrane Collaboration
Description:   This review found 69 studies that evaluated educational outreach visits. Educational outreach visits appear to improve the care delivered to patients. When trying to change how health care professionals prescribe medications, outreach visits consisten...
Date:   Aug 2007
Title:   Mutual Recognition Agreement on Conformity Assessment in relation to Medicines Good Manufacturing Practice Inspection and Certification between the Government of Australia and the Government of Canada
Publisher:   Australian Government Department of Health and Ageing
Description:   On 16 March 2004, the governments of Australia and Canada signed a Mutual Recognition Agreement (MRA) on Conformity Assessment in relation to medicines, Good Manufacturing Practice Inspection and Certification.
Date:   Mar 2004
Title:   Colourings permitted in medicines for oral use
Publisher:   Australian Government Department of Health and Ageing
Description:   This document includes a list of colourings permitted in complementary, OTC and prescription medicines for oral use and provides indicative data requirements for the evaluation of new colours for inclusion in medicines for oral use.
Date:   Jun 2004
Title:   Tamper-evident packaging
Publisher:   Australian Government Department of Health and Ageing
Description:   The Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (Edition 1, June 2003) has been developed under the direction of the Industry Government Crisis Management Committee (IGCMC), through its Subcommittee on Tamper-Evident Packaging.
Date:   Dec 2008
Title:   Common technical document (CTD)
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA currently accepts applications to register prescription medicines in both the old European Union (EU) format and the new Common Technical Document (CTD) format.
Date:   Nov 2008
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