THE UNIVERSITY OF NEWCASTLE- DISCIPLINE OF MEDICAL BIOCHEMISTRY

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1 Page: 1 of 4 1. Purpose: 1.1 To detail the requirements to be met when dealing with any imported biological products, or those marked 'AQIS' (Australian Quarantine Inspection Service). 2. Equipment: 2.1 N/A 3. Materials: 3.1 Incoming Goods Register (Stored in LS3-26). 3.2 AQIS Approved Biological Register (LS3-26). 3.3 GDP 004 Procedure for Registering Incoming Goods. (LS3-02). 4. Set Up: N/A 5. Method: 5.1 It is the users responsibility to comply with AQIS requirements. As listed in the CCH laboratory Safety Manual, all imported biological substances are grouped into two categories as follows: LOW RISK Human tissues, human genetic material and fluids (other than faeces), human cell lines and material known to be infected with a pathogenic microorganism synthetic laboratory reagents not derived from animal, plant, human or microbial sources organic chemicals and other substances such as purified acacia gums, pure agar, alcohols, cellulose, fish oils, gelatine, organic acids, paraffins, plant NAME (signed) DATE WRITTEN BY CHECKED BY AUTHORISED BY Distributed To: GDP Master File / GDP Lab File

2 Page: 2 of 4 colours, starches, sugars, vitamins (not including animal products or liver extracts) and wool fats non-biological buffers such as Tris and EDTA oligonucleotides and primers synthetic culture media HIGH RISK animal tissue extracts and fluids animal blood, sera and plasma products animal serum containing antibodies animal or microbiologically derived enzymes, hormones and proteins genetic material other than human microorganisms cell lines (including human) and their derived products culture media containing animal, plant, human or microbial material experimental, non-released vaccines human faeces known to be infected with a pathogenic microorganism. 5.2 For all products marked AQIS: Work must be limited to in-vitro use or in-vivo use in laboratory animals only; unless approved by AQIS for specific in-vivo use. Material may only be imported by, or on behalf of a scientific institution/laboratory registered by AQIS for the handling of imported biological material. On completion of work, all materials and derivatives thereof must be disposed of by incineration, autoclaving or another approved method. Material is for use only at the institution/laboratory for which it is imported and shall not be removed from these premises, except for disposal, without prior approval from the Director of Animal/Plant Quarantine. 5.3 There are extra requirements regarding the use of AQIS products in nonlaboratory animals. Non-laboratory animals include: birds, cattle, camels, dogs, goats, deer, horses, cats, marsupials, monotremes. sheep and pigs.

3 Page: 3 of 4 For details on the additional requirements associated with this work see the CCH Laboratory Safety Manual chapter on Biological Safety. 5.4 On the Incoming Goods Register, place 'AQIS' in the appropriate column to indicate that the good is an AQIS product. The following details must then be included in the separate 'AQIS Approved Biological Register'. (Both registers are kept in LS3-26): the date received the AQIS number the name of the supplier a description of the materials (name) the batch number purpose (the proposed research and analysis details) details of any special treatments (testing) the methods of disposal Quarantine officers may inspect all AQIS records, either by appointment or unannounced. They are to be retained for 18 months after receiving the goods. 5.5 For additional information visit the AQIS website: 6. Maintenance: 6.1 If any part of this procedure or requirements change, consult the professional officer so that corrections can be made and a new version issued. 7. Shutdown: 7.1 If you were required to read this GDP, sign the Requested Reading Record Sheet (Illustration 5.2) of GDP 001 Induction Procedure. 8. Safety Precautions: N/A 9. Attachments: 9.1 AQIS Approved Biologicals Register. 10. Check List: 10.1 Necessary records have been signed.

4 Page: 4 of References: 11.1 CCH Laboratory Safety Manual (Stored in LS3-26). 12. Change History: 12.1 Issue Number: 1st Issue Date Issued: 12.2 Issue Number: Date Issued: Reason for Change:

5 UNIVERSITY OF NEWCASTLE - DISCIPLINE OF MEDICAL BIOCHEMISTRY AQIS APPROVED BIOLOGICALS REGISTER DATE RECEIVED REAGENT SPECIFICATION No. PRODUCT NAME/DESCRIPTION QTY: Cat #: Lot #: NAME OF SUPPLIER QUARANTINE ENTRY NUMBER IMPORT PERMIT No. (if applicable) PROPOSED RESEARCH AND ANALYSIS DETAILS DETAILS OF ANY SPECIAL TREATMENTS DATE RESEARCH COMPLETED METHODS OF DISPOSAL DATES OF DISPOSAL REGISTER COMPLETED BY