Release for Supply
Packaging - In house and Contract
Jenny Hantzinikolas
Director Inspections and Compliance,
Manufacturing Quality Branch, TGA,
Dept. of Health
RACI
30/04/2015
Release for Supply
Overview
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Definition
Guidance document
Duties of an Authorised Person
Examples
Questions
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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
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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.
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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.
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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
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Release for Supply
Example 1- Release for Supply from a Secondary Packaging Site
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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.
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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.
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Release for Supply
Example 2 Re-release of a product after minor further steps of manufacture
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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.
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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.
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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.
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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 repackaging 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.
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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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