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Quality guidelines

22 July 2014

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Please note: Where European Union (EU) guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of prescription medicines by the TGA. The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation.

Active substance

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CPMP/QWP/227/02 Rev 1 (pdf,181kb)
EMEA/CVMP/134/02 Rev 1
Guideline on active substance master file procedure

Effective: 1 June 2013

TGA annotation:
EU-specific procedural requirements stated in this Guideline do not apply in Australia.

CHMP/QWP/297/97 Rev 1 corr (pdf,200kb)
Guideline on summary of requirements for Active Substances in the quality part of the dossier

Replaces: CHMP/QWP/297/97 (Adopted by TGA 12 February 2003)
Effective: 4 January 2006

TGA annotation:
The pharmacopoeias of EU member states, other than the British and European Pharmacopoeias (BP and Ph Eur), have no standing in Australia. The official standards in Australia are the British Pharmacopoeia (BP), the European Pharmacopoeia (Ph Eur) and the United States Pharmacopeia-National Formulary (USP).

Additional TGA requirements for active substances, Drug Master Files and Certificates of Suitability are set out in the Australian Regulatory Guidelines for Prescription Medicines.

CPMP/QWP/130/96 Rev 1 (pdf,208kb)
Guideline on the Chemistry of New Active Substances
Replaces: 3AQ5a (Adopted by TGA February 2002)
Effective: 12 February 2002

3CC29a (pdf,52kb)
Investigation of Chiral Active Substances
Replaces: III/3501/91 (Adopted by TGA 1 January 1995)
Effective: 12 February 2002

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CPMP/ICH/4106/00 (pdf296,kb)
ICH Topic Q 7
Note for Guidance on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Effective: 29 May 2002

TGA annotation:
This guideline has been adopted as a Manufacturing principle in Australia. Sponsors should refer to the Determination and the associated notation located on the Manufacturing pages of the TGA website.

CPMP/QWP/848/96 (pdf,65kb)
Note for Guidance on Process Validation

Effective: 27 March 2002

TGA annotation:
Although the guideline refers (in Section 6: Change Control) to Type I and II Variations and EC Regulations 541/95/EC and 542/95/EC, it should be noted that these legislative requirements are not applicable in Australia. Australian sponsors should refer to Australian guidance on Minor variations to registered prescription medicines: Chemical entities.

CPMP/QWP/2054/03 (pdf,159kb)
Annex II to Note for Guidance on Process Validation CHMP/QWP/848/96 and EMEA/CVMP/598/99 Non Standard Processes

Effective: 13 January 2005

CPMP/QWP/159/01 (pdf,26kb)
Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products

Replaces: 3AQ3a
Effective: 22 May 2002

TGA annotation:
Sponsors should note that the British Pharmacopoeia (BP 2014) states under Herbal Drugs (Ph Eur monograph 1433) that "the use of ethylene oxide for the decontamination of herbal products is prohibited."

CPMP/QWP/486/95 (pdf,56kb)
Note for Guidance on Manufacture of the Finished Dosage Form
Effective: 1 May 2000

CPMP/QWP/072/96 (pdf,21kb)
Note for Guidance on Start of Shelf-life of the Finished Dosage Form (Annex to Note for Guidance on the Manufacture of the Finished Dosage Form

Effective: 27 March 2002

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EMA/CHMP/CVMP/QWP/199250/2009 corr (pdf,417kb)
Guideline on setting specifications for related impurities in antibiotics
Effective: 1 June 2013

EMEA/CHPM/SWP/4446/2000 (pdf,155kb)
Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents
Effective: 1 May 2009

CPMP/SWP/5199/02 (pdf,56kb)
Guideline on the Limits of Genotoxic Impurities

Effective: November 2006

EMA/CHMP/SWP/431994/2007 Rev. 3 (pdf,167kb)
Questions and answers on the 'Guideline on the limits of genotoxic impurities'
Replaces: EMA/CHMP/SWP/431994/2007 Revision 2.
For information: 24 February 2014

CPMP/QWP/1529/04 (pdf,150kb)
Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeia General Monograph "Substances for Pharmaceutical Use" and General Chapter "Control of Impurities in Substances for Pharmaceutical Use"
Effective: 7 October 2004

CPMP/ICH/2738/99 (pdf,151kb)
ICH Topic Q 3 B (R2)
Note for Guidance on Impurities in New Drug Products

Status: Replaces ICH Q3 B (R) (Adopted by TGA 16 August 2004)
Effective: 1 May 2009

CPMP/ICH/2737/99 (pdf,63kb)
ICH Topic Q 3 A (R2)
Note for Guidance on Impurities Testing: Impurities in New Drug Substances

Replaces: CPMP/ICH/2737/99. ICH Topic Q 3 A (R) (Adopted by TGA 12 March 2003)
Effective: 1 June 2014

CPMP/ICH/283/95 (pdf,132kb)
ICH Topic Q3C (R4)
Impurities: Guideline for Residual Solvents

Replaces: CPMP/ICH/283/95. ICH Topic Q 3 C (R3) (Adopted by TGA 1 May 2009)
Effective: 1 June 2014

EMA/CHMP/ICH/82260/2006 (pdf,237kb)
ICH guideline Q 3 C (R5) on impurities: guideline for residual solvents
Effective: 1 June 2013

CPMP/QWP/450/03 - Rev 1 (pdf,109kb)
EMEA/CVMP/511/03 -Rev .1
Annexes to: CPMP/ICH/283/95 Impurities: Guideline for residual solvents & CVMP/VICH/502/99 Guideline on impurities: residual solvents

Annex I: specifications for class 1 and class 2 residual solvents in active substances
Annex II: residues of solvents used in the manufacture of finished products
Replaces: CPMP/QWP/450/03, EMEA/CVMP/511/03 (Adopted by TGA 13 January 2005)
Effective: 1 June 2014

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Specifications, analytical procedures and analytical validation

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EMA/CHMP/ICH/265145/2009 (pdf,173kb)
ICH guideline Q8, Q9 and Q10 - questions and answers volume 4
Replaces May 2009 version (provided for information May 2010)
For information: 1 April 2014

EMA/CHMP/ICH/379801/2009 (pdf,100kb)
ICH guideline Q4B annex 9 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on tablet friability - general chapter
Effective: 28 May 2010

EMEA/CHMP/ICH/381133/2009 (pdf,99kb)
ICH guideline Q4B annex 10 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on polyacrylamide gel electrophoresis - general chapter
Effective: 28 May 2010

EMA/CHMP/ICH/645592/2008 (pdf,100kb)
ICH guideline Q4B annex 8 to note for evaluation and recommendation of pharmacopoeial texts for use in region on sterility test - general chapter
Effective: 28 May 2010

EMA/CHMP/ICH/645469/2008 (pdf,100kb)
ICH guideline Q4B annex 7 (R2) to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test. General chapter
Replaces: EMEA/CHMP/ICH/645469/2008 (November 2009 version)
Effective: 24 February 2014

EMA/CHMP/ICH/308895/2008 (pdf,106kb)
ICH guideline Q4B annex 5 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test - general chapter
Effective: 28 May 2010

CPMP/QWP/3309/01 (pdf,196kb)
Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations

Effective: 15 November 2004

TGA annotation:
This Guideline provides useful guidance on the scientific principles and practical use of Near-Infrared (NIR) spectroscopy, and it supplements the technical information provided in the European Pharmacopoeia monograph on NIR spectrophotometry.

CPMP/QWP/3015/99 (pdf,59kb)
Note for Guidance on Parametric Release
Effective: 22 May 2002

CPMP/ICH/367/96 (pdf,426kb)
ICH Topic Q 6 A
Note for Guidance Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

Effective: 29 June 2001

CPMP/ICH/381/95 (pdf,186kb)
ICH Topic Q 2 (R1)
Note for Guidance on Validation of Analytical Procedures: Text and Methodology

Effective: 12 February 2002

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EMEA/CHMP/QWP/396951/2006 (pdf,127kb)
Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product
Replaces: 3AQ9a and CPMP/CVMP/QWP/115/95
Effective: 28 May 2010

CPMP/QWP/158/01 Revision (pdf,137kb)
EMEA/CVMP/115/01 Revision
Note for Guidance on Quality of Water for Pharmaceutical Use

Effective: 30 October 2002

TGA annotation:
In conformity with the Note for Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients - CPMP/ICH/4106/00 (which is adopted by the TGA effective from 29th May 2002), the TGA recommends that for the purposes of compliance with this guideline on water quality, potable water should comply with the latest WHO guidelines for drinking water quality.

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CPMP/QWP/4359/03 (pdf,181kb)
Guideline on Plastic Immediate Packaging Materials

Replaces: pp.75-82 of Rules 1998 (3A) - 3AQ10a
Effective: 1 December 2005


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CPMP/ICH/2736/99 (pdf,248kb)
ICH Topic Q 1 A (R2)
Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products

Effective: 24 August 2004

CPMP/QWP/122/02, rev 1 corr (pdf,161kb)
Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products
Replaces: CPMP/QWP/122/02 and CPMP/QWP/556/96
Effective: 16 June 2004

CPMP/ICH/420/02 (pdf,267kb)
ICH Topic Q 1 E
Note for Guidance on Evaluation of Stability Data

Effective: 24 August 2004

CPMP/ICH/421/02 (pdf,155kb)
ICH Topic Q 1 F
Note for Guidance on Stability Data Package for Registration in Climatic Zones III and IV

Effective: 17 September 2004

TGA annotation:
The TGA acknowledges this Guideline has been withdrawn by the ICH, as set out in Explanatory Note on the Withdrawal of ICH Q1F from the ICH Website.

This guideline remains adopted by the TGA because a significant portion of Australia lies in climatic zones III and IV. The guideline requires at least 12 months stability testing at 30°C/65% rh, 6 months testing at 40°C/75% rh, 3 months testing at 50°C (in certain circumstances) and 3 months testing at 25°C/80% rh (for solid dosage forms in water-vapour permeable packaging). However, the TGA allows some alternatives to these requirements, as follows:

  1. Testing at 50°C is not required.
  2. Testing at 25°C/80% rh is not required if the product shows satisfactory stability during long term testing at 30°C/65% rh.
  3. If a product does not show satisfactory stability for at least 3 months at 40°C/75% rh, there are several acceptable options:
    • argue that, as the container is designed to provide a barrier to water vapour, further investigation of stability under conditions of high humidity is not necessary; or
    • demonstrate, by testing at least 3 batches, that the product is stable for 3-6 months at 30°C/75% rh; or
    • package the product in a container/closure system that is less permeable to water vapour; or
    • label the product "Store below 25°C".
  4. If a product is labelled "Store below 25°C", the TGA will accept:
    • long term stability testing at 25°C/60% rh in place of 30°C/65% rh; and
    • 6 months testing at 25°C/80% rh or 30°C/65% rh (at least 3 batches) in place of 40°C/75% rh. Nevertheless, initial testing of the product should be conducted in accordance with the guideline, ie, at 30°C/65% rh and 40°C/75% rh. If stability is inadequate under these conditions (and, if tested, the alternative condition of 30°C/75% rh) the use of more protective packaging should be considered before the option of labelling the product "Store below 25°C".

Generally, if a product shows satisfactory stability for at least 3 months at a high humidity test condition (40°C/75% rh, 30°C/75% rh, 30°C/65% rh or 25°C/80% rh, as appropriate), then the TGA will consider a shelf life of up to 2 years, subject to satisfactory long term stability data. If a product is stable for 6 months under these conditions then a shelf life in excess of 2 years will be considered. [Any of these four storage conditions would be acceptable for high humidity testing of a product labelled "Store below 25°C", but only 40°C/75% rh or 30°C/75% rh would be acceptable for a product labelled "Store below 30°C".]

CPMP/ICH/4104/00 (pdf,184kb)
ICH Topic Q 1 D
Note for Guidance on Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products

Effective: 7 May 2003

CPMP/QWP/2934/99 (pdf,45kb)
Note for Guidance on In-Use Stability Testing of Human Medicinal Products
Effective: 27 March 2002

CPMP/QWP/159/96 Corr (pdf,30kb)
Note for Guidance on Maximum Shelf Life for Sterile Products After First Opening or Following Reconstitution (Annex to the Note for Guidance on Stability Testing of New Active substances & Medicinal Products (CPMP/ICH/380/95))
Effective: 23 February 2001

TGA annotation:
The allowance ".....unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions" detailed in the section: 'Unpreserved Sterile Products - Specific Text for Preparations for Infusion or Injection.' will only be permitted for products prepared in TGA licensed compounding facilities and in those hospital pharmacies that have been formally audited to the NCCTG standard and SHPA guidelines and have demonstrated that they can provide the appropriate level of sterility assurance.

CPMP/ICH/279/95 (pdf,150kb)
ICH Topic Q 1 B
Photostability Testing of New Active Substances and Medicinal Products

Effective: 1 October 1999

CPMP/ICH/280/95 (pdf,109kb)
ICH Topic Q 1 C
Note for Guidance on Stability Testing: Requirements for New Dosage Forms

Effective: 1 October 1999

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Pharmaceutical development

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EMEA/CHMP/167068/2004 (pdf,368kb)
ICH Topic Q 8 (R2)
Note for Guidance on Pharmaceutical Development

Effective: 15 June 2006

CPMP/QWP/054/98 Corr (pdf,43kb)
Decision Trees for the Selection of Sterilisation Methods (Annex to CPMP/QWP/155/96)
Effective: 15 December 2000

CPMP/QWP/155/96 (pdf,58kb)
Note for Guidance on Development Pharmaceutics
Effective: 1 May 2000

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Specific types of products

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EMEA/CHMP/CVMP/362268/2009 (pdf,43kb)
Concept Paper on the Revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies
For information: 26 March 2010

EMEA/CHMP/QWP/306970/2007 (pdf,113kb)
Guideline for Radiopharmaceuticals
Effective: 22 June 2009

CPMP/QWP/1719/00 Rev 1 (pdf,102kb)
Guideline on Medicinal Gases: Pharmaceutical Documentation (Including Recommendation on Non-Clinical Safety Requirements for Well Established Medicinal Gases)
Replaces: CPMP/QWP/1719/00 (Adopted by TGA 12 March 2003)
Effective: 26 June 2009

EMEA/CHMP/QWP/49313/2005 Corr (pdf,238kb)
Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products
Effective: 1 October 2006

CPMP/QWP/604/96 (pdf,84kb)
Note for Guidance on Quality of Modified Release Products:
A: Oral Dosage Forms
B: Transdermal Dosage Forms
Section I (Quality)

Effective: 19 April 2001

3AQ21a (pdf,50kb)
Radiopharmaceuticals Based on Monoclonal Antibodies
Effective: 12 February 2002

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Web page last updated: Tuesday, 22 July 2014