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Australian regulatory guidelines for sunscreens (ARGS)

Version 1.2

30 August 2019

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8. Manufacture and quality control

This guideline is currently under review.

8.1 Manufacture

In accordance with Part 3-3 of the Act and Part 4 of the Regulations, manufacturers of 'listed' or 'registered' therapeutic goods destined for the Australian market or for export from Australia to an overseas market must be licensed or approved by the TGA and must also comply with manufacturing principles as determined by the Minister. These manufacturing principles are set out in the TGA's requirements for good manufacturing practice (GMP).

Where an Australian manufacturer is nominated in an application to list or register a sunscreen, that manufacturer must be licensed by the TGA to manufacture such products and must comply with the TGA's GMP requirements as relevant to sunscreens. Where the product is imported, each nominated overseas manufacturer is expected to comply with a code of GMP equivalent to that applying to Australian manufacturers and the TGA must have issued a GMP clearance for that manufacturer.

Further information on licensing or approval of manufacturers is available on the TGA Internet site.

8.2 Quality control

It is the responsibility of the manufacturer of the finished therapeutic product to ensure the quality of the product and also that of the active ingredients and excipients used in its manufacture.

Section 40(4)(a)(i) of the Act requires the manufacturer to ensure that the product complies with any standard applicable to the product.

In accordance with the definitions in section 3 of the Act, the default standards applying to therapeutic goods registered or listed in the ARTG are the British Pharmacopoeia (BP), European Pharmacopoeia (Ph Eur) and United States Pharmacopeia-National Formulary (USP-NF). Other standards in addition to the pharmacopoeia that apply to sunscreens include relevant Therapeutic Goods Orders made under section 10 of the Act (for example, TGO No. 69 for labelling and TGO No. 77 for microbiological quality).

This means that if there is a monograph for a finished product in one (or more) of the BP, Ph Eur and USP-NF, then the sponsor must ensure that the product will comply with the specifications in that monograph (or at least one of those monographs).

Sunscreen finished products are not the subject of a monograph in the BP, Ph Eur or USP-NF and therefore must to be controlled, instead, by appropriate "in house" quality control specifications that control and ensure their identity and relevant physical, chemical and microbiological properties. Test methods must be validated, as appropriate.

Therapeutic sunscreen products in all categories are required to comply with the relevant requirements of sections 8 and 9 of Therapeutic Goods Order No. 77 Microbiological Standards for Medicines.

Sunscreen manufacturers are responsible to ensure that batches of product released to the market comply with their specifications.

Subsection 13(5) of the Act requires that, when a finished product is not the subject of a monograph in the BP, Ph Eur or USP-NF, but any of its ingredients is the subject of a monograph in one or more of those pharmacopoeia, that ingredient must comply with at least one of the monographs concerned, unless the Minister has issued an order determining that this requirement does not apply to the goods concerned. Note that, as at the date these Guidelines were published, no such order exempting sunscreens had been issued by the Minister.

Many of the organic chemicals used as active ingredients in sunscreens are the subjects of monographs in the USP-NF (generally under their International Non-proprietary Names [INNs]) while the inorganic substances titanium dioxide and zinc oxide are the subject of monographs in each of the BP, Ph Eur and USP-NF.

Many of the excipients (including solvents) used in sunscreen products are the subjects of monographs in one or more of the BP, Ph Eur and USP-NF.

Ingredients that are not the subject of a monograph in the BP, Ph Eur or USP-NF must be controlled by appropriate quality control specifications that control and ensure their identity, relevant physical and chemical properties, and purity. Test methods must be validated, as appropriate.

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