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TGA presentation given at RACI Therapeutic Goods Packaging seminar, 30 April 2015

Release for supply: Packaging - in house and contract

13 July 2015

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Presentation

  • Presented by: Jenny Hantzinikolas, Director Inspections and Compliance, Manufacturing Quality Branch, TGA, Department of Health
  • Presented at: RACI, 30 April 2015
  • Presentation summary: This presentation discusses release for supply.

Transcript

Release for supply: Packaging - in house and contract

Jenny Hantzinikolas
Director Inspections and Compliance,
Manufacturing Quality Branch, TGA,
Dept. of Health

RACI, 30 April 2015

Slide 1 - Release for supply

Overview

  • Definition
  • Guidance document
  • Duties of an Authorised Person
  • Examples
  • Questions

Slide 2 - Release for supply

What is release for supply?

  • Release for Supply is a mandatory step in which the last manufacturer in the supply chain certifies each batch of medicines before it is released to the Australian market.
  • This is to ensure that the batch has been manufactured and quality controlled in accordance with all the requirements under the Therapeutic Goods Act 1989

Slide 3 - Release for supply

Guidance document

  • A guidance document, was developed in consultation with industry.
  • It is published by the TGA to provide industry with guidance on release for supply of medicines. The guidance document consists of two parts:
    • Part 1: Provides guidance on the general requirements applicable to all manufacturers and sponsors; and
    • Part 2: provides examples of how the general requirements described in Part 1 can be met for specific areas of manufacture (for example, complementary medicines or sunscreens, or for different supply chains).
    • Part 2 is a living document.

Slide 4 - Release for supply

Duties of an Authorised Person

  • The Authorised person must be satisfied that
    • The batch has been produced and controlled in accordance with the requirements of Marketing Authorisation
    • The batch has been produced and controlled in accordance with the Code of GMP as defined in the manufacturing principles
    • All manufacturers involved in producing the batch hold a TGA licence or GMP clearance and included on the ARTG ( except investigational medicinal products)
    • Any significant deviations or planned changes in production or quality control have been authorised by persons in accordance with a defined system.

Slide 5 - Release for supply

For the release for supply manufacturing step...

  • GMP agreement is in place that specifies that the AP ensures that each batch is manufactured and checked in accordance for marketing authorisation
  • GMP agreement specifies who is responsible for any significant deviations, OOS results, non compliance with GMP, investigations, complaints or other matters
  • The process should always be able to identify and recall product without delay.
  • Where the ARTG identifies more that one site for release for supply then the sponsor must know which site did perform the release for supply

Slide 6 - Release for supply

Example 1- Release for Supply from a Secondary Packaging Site

Flow diagram of release for supply from a secondary packaging site - First is bulk product manufacture and primary packaging (sites(s) 1) Second is the release for further processing (AP1) Third is labelling and/or secondary packaging (Site 2) Fourth is Release for supply (AP2)

Slide 7 - Release for supply

Example 1- Release for Supply from a Secondary Packaging Site

Description of specific issue

  • As the primary packaging will not be altered it is accepted that there will be no change to the stability profile.
  • AP1 at the manufacturing site(s) conducting bulk manufacture and/or primary packaging has certified that these steps have been conducted in accordance with the MA. This certification and supportive documentation will be provided to AP2 conducting release for supply.

Justification for requested interpretation:

  • The additional steps represent no further risk to the product and all applicable aspects of manufacture up to the step of release for further processing have been completed in accordance with cGMP requirements.

Slide 8 - Release for supply

Example 1- Release for Supply from a Secondary Packaging Site

Required items to address cGMP compliance:

  • AP1 conducting release for further processing will provide the following information.
  • A batch specific certification for compliance to the Australian MA for the steps of manufacture covered. The certification should include, for example: assurance that the batch has been manufactured in accordance with the MA, any deviations that may impact product quality, efficacy, safety and shelf life have been resolved and verification that product label storage requirements have been maintained.
  • A certificate of analysis for the batch.

Slide 9 - Release for supply

Example 2 Re-release of a product after minor further steps of manufacture

Flow diagram of Re-release of a product after minor further steps of manufacture - First is bulk product manufacture, primary and secondary packaging (Site(s) 1) Second is release for supply (AP1) Third is re-labelling and/or secondary re-packaging (site 2) Fourth is re-release for supply (AP2)

Slide 10 - Release for supply

Example 2 Re-release of a product after minor further steps of manufacture

Description of specific issue:

  • As the primary packaging will not be altered it is accepted that there will be no change to the stability profile.
  • AP1 at the manufacturing site(s) conducting bulk manufacture, primary packaging and secondary packaging has certified that these steps have been conducted in accordance with the MA.
  • This batch release certification and supportive documentation will be provided to AP2 conducting re-release for supply.

Slide 11 - Release for supply

Example 2 Re-release of a product after minor further steps of manufacture

Justification for requested interpretation:

  • The additional steps represent no further risk to the product,
  • Reasons are there are no changes made to the product expiry date at Site 2 and all applicable aspects of manufacture including the step of Release for Supply have been completed in accordance with cGMP requirements.

Slide 12 - Release for supply

Example 2 Re-release of a product after minor further steps of manufacture

Required items to address cGMP compliance:

  • AP1 conducting release for supply will provide the following information.
  • A batch specific certification for compliance to the Australian MA for the steps of manufacture covered.
  • The certification should include, for example: assurance that the batch has been manufactured in accordance with the MA, any deviations that may impact product quality, efficacy, safety and shelf life have been resolved and verification that product label storage requirements have been maintained.
  • A certificate of analysis for the batch.

Slide 13 - Release for supply

Example 2 Re-release of a product after minor further steps of manufacture

  • A mechanism must be established, by the relevant parties identified in the GMP agreement, to ensure that information becoming evident in the re-packaging step, relevant to compiling the Product Quality Review (PQR), is communicated to the site responsible for preparing the PQR.
  • A formal assessment concluding that the additional steps represent no further risk to the product should be completed prior to re-packaging.
  • This assessment should clearly demonstrate the modifications being performed have no impact on stability or will generate information suitable for verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements.

Slide 14 - Release for supply

Questions?

  • If you have any examples for Part 2, please make contact with one of the following
    • Accord
    • Australia New Zealand Industrial Gas Association
    • Australian Self Medication Industry
    • Complementary Medicines Australia
    • Generic Medicines Industry Australia
    • Medicines Australia

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