Guidance for TGO 101: Standard for Tablets, Capsules and Pills v1.0, April 2019
This guidance is to help sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101, the Order) in ensuring that these types of therapeutic goods are of appropriate quality.
The information in this guidance may also assist other stakeholders to understand how sponsors and manufacturers assure that medicines that are tablets, capsules or pills are of good quality.
Compliance with TGO 101 is not necessarily sufficient to demonstrate quality, safety or efficacy for the purposes of registering or listing a medicine. Additional requirements may be applied, for example, as conditions of listing or conditions of registration.
In some instances, compliance with TGO 101 may not be sufficient to establish the safe use of medicines. Sponsors will need to further consider the intended patient population, size of the recommended daily dose, etc. to ensure that their medicines are safe for the purpose for which they are to be used.
Consideration must also be given to any other relevant standards.
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