Authorised person responsibilities

The authorised person certifies:

'that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, control and release of medicinal products' (PIC/S Guide to GMP, clause 1.4 xv).

The authorised person taking responsibility for release for supply is to:

1. have full access to, and detailed knowledge of all the following authorisations and standards:
   1. marketing authorisation, including details in the ARTG and other matters agreed on in writing between TGA and the Australian sponsor
   2. PIC/S Guide to GMP as defined in the manufacturing principles (for domestic sites), or at least equivalent for overseas sites
   3. default standards, where they apply
   4. all applicable Therapeutic Goods Orders
2. complete all duties of an authorised person
3. provide a legally valid signature for every batch released
4. have detailed knowledge of the steps in manufacture for which responsibility is taken
5. keep their knowledge up to date, in accordance with the PQS, in light of both:
   1. technical and scientific progress
   2. changes in quality management relevant to the products they release
6. have access to appropriate information to consider the release for supply results within the context of both:
   1. product quality review (PQRs) findings
   2. ongoing stability program data

Duties of an authorised person performing RFS

Before release of a production batch for supply, the authorised person is responsible for ensuring:

1. each batch has been produced and controlled in accordance with all the requirements of:
   1. any marketing authorisations (item 7, clause 1.9, Part 1 of the PIC/S Guide to GMP), including:
      1. all details in the ARTG
      2. all other details agreed in writing between the TGA and the Australian sponsor in relation to the marketing authorisation
   2. any other regulations relevant to the production, control and release of the therapeutic good manufactured under GMP (item xv, clause 1.4, Part 1of the PIC/S Guide to GMP)
   3. the PIC/S Guide to GMP for domestic manufacture or if manufactured overseas, in accordance with good manufacturing practice standards, at least equivalent to the PIC/S Guide to GMP
2. all manufacturers involved in producing the batch are to:
   1. hold a TGA licence or be covered by a current GMP clearance for all of the manufacturing steps they have performed
   2. be included in the ARTG entry for the manufacturing steps performed
   3. have the services of at least one authorised person available at each site
   4. have any partial manufacturers or outsourced activities covered by valid GMP agreements in accordance with chapter 7 of the PIC/S Guide to GMP
3. all processes have been fully validated, taking into account the actual production conditions, manufacturing and test records for the:
   1. principal manufacturing processes
   2. release testing processes (as per finished medicinal product specifications)
4. all necessary production and quality control documentation is complete and approved by authorised staff, including out-of-specification (OOS) investigations
5. all the necessary checks and tests have been performed; including any additional sampling, inspection, tests or checks initiated due to deviations or planned changes
6. product quality reviews have been performed in a timely manner and are accurate
7. any significant deviations or planned changes in production or quality control have been:
   1. authorised by the persons responsible in accordance with a defined system.
   2. notified to and authorised by TGA if any changes require variation to the marketing authorisation, manufacturing licence or GMP clearance
8. all necessary steps have been completed in accordance with the pharmaceutical quality system (PQS), regardless of how many sites are involved
9. GMP internal audits and supplier audit systems are operational
10. check that the shelf life is supported by the available ongoing stability data, as described in Releasing medicines manufactured at multiple sites
11. any other factors of which the authorised person is aware, which are relevant to the quality of the intermediate product, bulk and finished product batch, have been considered, such as:
    1. significant deviations
    2. out-of-specification results
    3. non-compliance with GMP
    4. investigations
    5. complaints
    6. other related matters throughout production from all manufacturing sites
12. The authorised person may delegate tasks to appropriately trained personnel or third parties to verify the RFS requirements have been met. We recognise that the authorised person will need to rely on a pharmaceutical quality system (PQS), so the authorised person should have on-going assurance that this reliance is well founded.
13. Where release for supply involves multiple manufacturing sites, be aware of your additional responsibilities