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Half yearly performance report - January to June 2015

16 December 2015

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10. Laboratory testing

The Laboratories Branch conducts post-market monitoring and compliance testing, investigations and reviews, as well as market authorisation assessment of therapeutic goods.

Information on the Laboratories Branch activities and Laboratory Testing Plan can be found on the TGA website.

Table 54: Samples and products tested by type of therapeutic good and percentage which failed
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Prescription medicines Total 540 377 483
% fail 1% 1% 0.2%

OTC medicines

Total 15 20 24
% fail 0% 40% 21%

Complementary medicines

Total 200 77 79
% fail 27% 30% 13%

Medical devices

Total 69 75 42
% fail 30% 19% 7%

Contracta

Total 47 23 60
% fail 0% 22% 3%

Unregisteredb

Total 186 166 111
% fail 82% 54% 84%
Total samples per half yearc 1289 1013 980
Total samples per half year
(excluding AHQ samples)
1057 738 799
Percentage fail per half year 22% 19.6% 14.3%
Total number of products tested per half yeard 507 403 405
  1. Performed on request for overseas regulators or aid agencies and encompasses medicines and medical devices.
  2. Unregistered refers to products that meet the definition of therapeutic goods but are not included on the ARTG or otherwise specifically exempted from this requirement in the legislation. This often includes adulterated complementary medicines or counterfeit products.
  3. Includes accreditation, harmonisation and quality control (AHQ) samples.
  4. The TGA may test a number of samples of each product per reporting period.
Table 55: Samples that failed laboratory testing by reason for failed between January and June 2015
Medical devices OTC medicines Prescription medicines Unregistered products Complementary medicines Total
Contamination 0 0 0 3 7 10
Formulation 0 2 1 86 1 90
Label and packaging deficiencies 0 0 0 0 1 1
Performance 2 0 0 4 1 7
Physical or mechanical properties 1 3 0 0 0 4
Total 3 5 1 93 10 112
Table 56: Batch release and export certification
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Batch releasea 225 152 242
Export certification 36 5 9
  1. Vaccines, biotechnology and blood products: evaluation of batch release documentation.
Table 57: Target timeframes in working days for laboratory testing by priority and testing type
Priority of testing Biochemical/chemical testing Microbiological testing Medical device testing
Urgent 20 (95% of target times to be met) 40 (95% of target times to be met) 20 (95% of target times to be met)
Priority 40 (80% of target times to be met) 50 (80% of target times to be met) 40 (80% of target times to be met)
Routine 50 50 50

Compliance against these timeframes are outlined in table 58.

Samples involving complex biological assays are excluded from the target turnaround timeframes.

Table 58: Compliance with testing timeframes between January and June 2015
Priority Total Percentage
Medical devices Routine 64 56%
Priority 6 100%
Urgent 1 100%
OTC medicines Routine 26 96%
Priority 0 N/A
Urgent 0 N/A
Prescription medicines Routine 125 70%
Priority 3 100%
Urgent 31 94%
Complementary medicines Routine 87 81%
Priority 3 67%
Urgent 2 100%
Unregistered products Routine 2 0%
Priority 78 94%
Urgent 24 100%

Low numbers of samples within categories may affect compliance percentages. Urgent testing may impact on the timeframes for priority and routine testing.

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