Target timeframes for manufacturing inspections

Version 1.0, August 2017

4 August 2017

Where required, the TGA will inspect manufacturing sites that are required to manufacture goods in accordance with Good Manufacturing Practice (GMP). Our target timeframes for these inspections are outlined in the tables below.

All timeframes are variable depending on the cooperation of manufacturers, sponsors and sometimes international regulatory agencies. We may not grant a licence or issue a certification until all deficiencies identified during an inspection have been resolved.

Target timeframes for manufacturing inspections

Our timeframes differ depending on whether the manufacturer is in Australia or overseas.

Australian licence timeframes
Application type Time period Target timeframe
New Australian licence application Effective application to inspection scheduling ≤ 2 months
Inspection scheduling to conducting inspection ≤ 1 month
Inspection to PIL (post inspection letter) ≤ 1 month
Inspection close out Between 10 and 30 weeks *
Variation to scope, premises or conditions of Australian licence not requiring on-site inspection Effective application to grant of licence ≤ 3 months
Re-inspection of licensed premises Inspection due date to inspection ≤ 6 months
Issue of certificate: GMP certificate or notarised copy of licence Effective application to certificate issue ≤ 15 working days
  • ♣: Time periods do not start until the application is 'effective' (i.e. application fees have been paid and all required documentation has been supplied);
  • * Depends on inspection compliance rating
GMP certification timeframes (overseas manufacturers)
Application type Time period Target timeframe
New GMP certification application Effective application to inspection scheduling ≤ 5 months
Inspection scheduling to conducting inspection ≤ 1 month
Inspection to issuing PIL ≤ 1 month
Inspection close out Between 10 and 30 weeks *
GMP re-certification: re-inspection of compliant premises Inspection due date to inspection ≤ 6 months
  • ♣: Time periods do not start until the application is 'effective' (i.e. application fees have been paid and all required documentation has been supplied);
  • * Depends on inspection compliance rating

Overview: GMP certification timeframes

GMP certification timeframes

Text version of Flowchart

  1. Application lodged
  2. Application free payment processed - within 2-3 days
  3. Application reviewed - within 4 weeks

    Note: Time periods do not start until the application has been deemed effective by TGA (ie: all fees have been paid and all required evidence has been supplied)

  4. Inspection scheduling - within 12-24 weeks
    • For certification: 8-16 weeks
    • For licences: 2-4 weeks
  5. Onsite inspection conducted - within 4 weeks
  6. PIL issued
  7. Inspection closeout
  8. Inspection fee reconciliation - between 10-30 weeks
  9. Licence granted / GMP certificate or clearances issued

Version history

Version Description of change Author Effective date
V1.0 Original publication Manufacturing Quality Branch August 2017