TGA use only

This form, when completed, will be classified as 'For official use only'.
For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <

Certified product details (CPD)

Biological prescription medicines and vaccines

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  • This form and all attachments should be supplied electronically as a single PDF document with bookmarks/hyperlinked index
  • Email this form to:
–r Biological Medicines and;
– for Vaccine products

Part 1 - Product details

Trade name:
Drug substance(s):
Dosage form(s):
Strength(s):
Presentation:
Name of Australian sponsor:
Address of sponsor:
ARTG number(s):
Date and version of this CPD:

Formulation

Ingredient / Amount
(mg unless stated) / Concentration
(mg/mL unless stated) / Reference

Part 2 - Previous CPD details

Date and version of CPD / Superseded / Current
Summary of differences between current and superseded CPD

Part 3 - Manufacturing and specifications

Working seed testing procedures and specifications (for vaccines only)

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  • Working seed testing SOPs should be supplied only for those assays that are crucial, such as potency, identity and purity, and that are not repeated for the drug product. This may include inactivation, splitting and other parameters for vaccines.
  • All SOPs should be supplied with either bookmarks or a hyperlinked index
  • SOPs should be copies of the SOPs used by the quality control laboratory, or contain as much detail as is required to reproduce the method in another laboratory

Drug substance manufacturing flow chart

insert drug substance manufacturing flowchart here, extend as necessary

Drug substance testing procedures and specifications

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  • Drug substance SOPs should be supplied only for those assays that are crucial, such as potency, identity and purity, and that are not repeated for the drug product. This may include inactivation, splitting and other parameters for vaccines.
  • All SOPs should be supplied with either bookmarks or a hyperlinked index
  • SOPs should be copies of the SOPs used by the quality control laboratory, or contain as much detail as is required to reproduce the method in another laboratory

Test / Method / Method reference / Specification at release
Appearance
Identity
Potency and Content
Purity
Contaminants
Physicochemical
Safety

Shelf life and storage conditions for the drug substance

Drug product manufacturing flow chart

insert drug product manufacturing flowchart here, extend as necessary

Drug product testing procedures and specifications

/
  • All SOPs should be supplied with either bookmarks or a hyperlinked index
  • SOPs should be copies of the SOPs used by the quality control laboratory, or contain as much detail as is required to reproduce the method in another laboratory
  • For vaccines, this should include both formulated bulk and final container procedures, specifications, hold time, shelf life and SOPs

Test* / Method / Method reference / Specification at release / Specification at expiry
Appearance
Identity
Potency and Content
Purity
Contaminants
Physicochemical
Safety

*- The approved release specifications for vaccine products may include additional test parameters, please add as necessary

Current and previous reference materials

Reference type / Use / ID No. / Derived from / Current / superseded / TGA approved
Submission No.

Method ofsterilisation of drug product and/or container

Method of sterilisation of drug product:
Method of sterilisation of container:

Shelf life and storage conditions

Unopened:
Reconstituted:
Warnings:
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  • All allowable temperature excursions that deviate from the approved shelf life temperature range MUST have prior TGA approval
  • If the sponsor does not have approval for temperature excursions beyond the approved shelf life temperature range, the sponsor must submit temperature data to the TGA to gain approval to release the affected batch.

Permitted temperature excursions

Temperature interval / Time allowed in deviated temperature range / TGA approved? / TGA submission No.

Current exemptions

Section 14 of the Therapeutic Goods Act 1989
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  • If the company has been granted any exemptions from compliance with a standard e.g. specification of a pharmacopoeial monograph, labels not in compliance with Therapeutic Goods Order No. 69- General requirements for labels for medicines, please enter them in the table below.

Standard / Exemption / Date / Period / TGA File No.

Part 4 - Declaration

  • I confirm that the contents of this version of the CPD are accurate and complete.
  • I confirm that all details in this version of the CPD are unchanged as compared with those in the previous version, with the exception of those summarised in Part 2 of this form.
  • Where submitted immediately following evaluation of a full quality and manufacturing data package, I take responsibility that the information in this document accurately reflects the contents of the application and any subsequent correspondence.

Name of authorised officer:
Position/relationship to sponsor:
Telephone No.: / Fax No.:
Email address:
Date:
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Appendices

  • SOPs for all requested assays for both drug substance (where applicable) and drug product should be supplied as appendices in a single PDF document, preferably with bookmarks and a hyperlinked index.
  • SOPs should be copies of the SOPs used by the quality control testing laboratory, or contain as much detail as is required to reproduce the method in another laboratory.

Certified product details (CPD) - Biological prescription medicines - Biological prescription medicines and vaccines
(October 2016)

For official use onlyPage 1 of 6