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Testing of biological medicines

Applicable to biological medicines, excluding vaccines, anti-venoms and toxins

19 July 2019

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Test methods and handling of results

We inform you of our test results in a test report letter.

We publish a summary of all TGA test results twice a year on our database of TGA Laboratory testing results.

TGA test methods

For testing biological medicines, we are increasingly using validated TGA in-house orthogonal screening techniques. We apply internal acceptance criteria based on either:

  • the most stringent
  • OR
  • the mean or median

from approved specifications of the tested group of biological medicines

Results of testing

Products whose results are:

  • within screening acceptance criteria are reported as passing
  • outside, or close to, the screening acceptance criteria are retested

Retesting methods

In re-testing samples, which do not meet TGA in-house screening acceptance criteria, we use:

  • pharmacopoeial methodologies where available, however we will apply the approved specifications if they differ from the pharmacopoeial standards
  • OR
  • methodologies and specifications detailed in the Certified Product Details (CPD), where pharmacopoeial methods aren't available

Retest results

If non-compliance is confirmed using compendial or CPD methods, we will inform you and negotiate an appropriate course of action:

  • for marginal failures or for failures in non-critical quality attributes, this may be:
    • a simple information letter,
    • a warning
    • a possible request for further samples (for testing)
  • for significant failures to critical quality attributes or failures which may have safety implications:
    • the batch may be recalled
    • you may be required to send 'Dear Doctor' letters
  • if you disagree with our test results, you may nominate a third party to carry out additional testing

Validating or verifying a method for TGA use

Before we use any method, we validate or verify their use according to the following standards:

Screening and CPD methods may require standards and internal controls, which only the manufacturer can supply. Such reagents may need to be verified before use in batch release. In such cases, after completion of the second round of evaluation, we may request:

  • a CPD document
  • pre-registration samples
  • standards
  • consumables

Certified Product Details (CPD)

The Certified Product Details (CPD) of a biological medicine specifies its:

  • formulation
  • manufacturing process
  • test methods
  • specifications

When a new biological medicine is registered, ensure you provide us with an electronic draft of the CPD, as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines.

A template to prepare a CPD is available on our website.

Once drafted, send your CPD as a single pdf document to us. You can also use this address as a first point-of-contact on any testing issue.

Approved changes to existing ARTG entries

When we have approved a change to an existing ARTG entry, either through a category 3 application or a self-assessable change, ensure you provide an updated CPD to the:

  • active substance
  • product specifications and/or test methods

Treatment of confidential information

As laboratory protocols and reference standards may be subject to intellectual property protection, we treat all information supplied in the CPD as official information as detailed in Treatment of information provided to the TGA.

Temperature excursions

Deviations from approved storage conditions may cause a biological medicine to be of unacceptable quality and therefore not suitable for supply.

There are ways you can gain permanent approval of temperature excursions (of specified and validated magnitude and duration) to allow you to manage them under GMP. See Temperature excursions of biological medicines.

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