This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.

1. Therapeutic Goods (Standard for Tablets,
Capsules and Pills) (TGO 101) Order 2019
Post-market compliance monitoring of listed
medicines
Dr Adam Cook
Director – Listing Compliance Section
Complementary & OTC Medicines Branch
13 May 2019

2. Part 2 -Tablets and capsules
Division 1 - Requirements for tablets and capsules
8 General requirements
(1) When there is an applicable monograph:
(a) those requirements specified in that monograph, subject to the matters specified in
Division 2; or
(b) those requirements specified in Division 3 (the Australian specific requirements)
together with the requirements relevant to the tablet or capsule that are specified in one of the
following:
(i) the general monographs in the EP;
(ii) the general monographs in the BP;
(iii) the general chapters of the USP-NF.
(2) When there is no applicable monograph are:
(a) the Australian specific requirements; and
(b) the requirements relevant to the tablet or capsule that are specified in one of the
following:
(i) the general monographs in the EP;
(ii) the general monographs in the BP;
(iii) the general chapters of the USP-NF.
TGO 101 – Listed medicines compliance 1

3. What are some of the monographs that may be relevant
to listed medicines?
This includes*:
- BP (EP) general monographs for capsules and tablets
- BP (EP) individual monographs (for formulated preparations)
- BP (EP) monographs for medicinal and pharmaceutical substances
- BP (EP) Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal
Products
- USP-NF <2> Oral Drug Products - Product Quality Tests
- USP-NF <2021> to <2750> Dietary Supplements chapters
- USP-NF individual monographs
- USP-NF Dietary Supplements monographs
* Not exhaustive
TGO 101 – Listed medicines compliance 2

4. Australian specific requirements (Division 3)
• Same as TGO 78
– Assay of each active ingredient; limits specified in Schedule 1
and Schedule 2
– Tablets or capsules containing 100 mcg or more folic acid
– Dissolution
– Disintegration
– Fineness of dispersion for dispersible tablets
– Uniformity of dosage units and uniformity of weight
• New in TGO 101
– Elemental impurities and residual solvents
TGO 101 – Listed medicines compliance 3

5. Post-market assessment of compliance
• TGO 101: tool to control risks that impact safety and efficacy:
– Improper dissolution leading to incorrect dosage being delivered;
– Solvent residues and elemental impurities leading to toxicity or allergic
reactions;
– Non-uniform dosage units leading to incorrect dosage being delivered; etc
• The design of the medicine (including initial stability data), together with its
overall risk control strategy and validation (including ongoing stability data) can
be used to demonstrate compliance with TGO 101
• Control of risks in the finished good must be demonstrated, but this may be via
– testing of the finished good or testing of raw materials, or
– By some other means so long as control of the risk in the finished good
can be demonstrated.
TGO 101 – Listed medicines compliance 4

6. Post-market assessment of compliance
• Example: elemental impurities
– If testing is conducted at the raw material stage only
 Evidence must be held to demonstrate that introduction of elemental
impurities into the finished goods subsequent to raw material
qualification will not occur to ensure compliance with Permitted Daily
Exposures (PDEs).
 Introduction during manufacturing? Testing of solvents; Validation of
filtering or purification steps
TGO 101 – Listed medicines compliance 5

7. Post-market assessment of compliance
• It is not expected that all of the tests set out in the TGO 101 must be
performed on all medicines, or on all batches of a medicine.
• It is up to the sponsor to demonstrate how the risks have been controlled
and therefore, compliance with TGO 101.
• Applicable monographs must be followed in full
• Sponsors cannot select tests and limits from different default standards to
create a unique testing protocol (i.e. no ‘cherry picking’)
TGO 101 – Listed medicines compliance 6