This content is current only at the time of printing. This document was printed on 10 September 2020. A current copy is located at http://www.xlg888.com/node/15516
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Criteria for Appointment as Approved Analyst
Claims against the following criteria will guide the APVMA in any decision to appoint a person to be an approved analyst and must be complied with for the duration of appointment.
- ability to prepare a Certificate of Analysis in the required format
- ability to comply with the Guidelines for Approved Analysts at (Appendix 1)
- demonstrated experience, professional and technical skills in the fields of calibration and/or chemical testing and/or biological testing
- relevant formal qualifications and current employment, including as a sub-contractor, in a NATA accredited or other APVMA approved facility. Examples of acceptable qualifications include:
- Degree in applied science
- Degree in life science
- Degree in chemistry (applied or analytical)
- Degree in microbiology; or
- Diploma/Certificate in chemistry, microbiology or laboratory techniques
- ability to perform all requested analytical services at National Association of Testing Authorities (NATA) or International Accreditation New Zealand (IANZ) (for New Zealand based appointed analysts) accredited facilities (laboratories)1or other laboratories approved by the APVMA
- ability to maintain copies of all records and other documentation relating to services, including:
- the results
- quality assurance procedures
- analytical and testing methods
for a period of seven years.
Please note that appointment or accreditation does not guarantee engagement or procurement of services from any analyst or accredited laboratory by the APVMA. Procurement of services is a separate exercise conducted in accordance with the Commonwealth Procurement Guidelines, however appointment and accreditation is the prerequisite for the APVMA to seek such services.
Analytical services may be commissioned by either applicants, approval holders or registrants, or by the APVMA for the purpose of compliance and enforcement or specific requests under Section 99 of the Agvet Code.
Guidelines for Provision of Services by Approved Analysts
These guidelines set out the expected behaviour and protocols for approved analysts when acting on behalf of the APVMA or other parties for the purposes of the Agricultural and Veterinary Chemicals Administration Act 1992 and Agricultural and Veterinary Chemicals Code Act 1994.
1. Nomination of contact person
1.1 The approved analyst must nominate a contact person or official representative (eg laboratory manager). Details of the nominated contact will be published on the APVMA website (and in the APVMA Gazette at the time of appointment).
1.2 The approved analyst must notify any change in contact details to the APVMA in writing, as soon as practicable.
2.1 The approved analyst must comply with the criteria, as outlined previously in this document.
2.2 Any inability to meet the criteria must be notified to the APVMA within a reasonable period as soon as practicable using the ‘Required information for approved analysts’ form.
3. NATA accreditation (for analysis at laboratories that are NATA accredited)
3.1 The approved analyst must only provide services via a laboratory maintaining the NATA scope of accreditation for the class of test and testing methodology (eg chemical testing, biological testing etc.).
3.2 Testing by the approved analyst for the purposes of agricultural and veterinary chemicals legislation must be undertaken using methods appropriate to the class of test for which the laboratory has NATA accreditation, unless otherwise approved in writing by the APVMA.
3.3 The approved analyst must maintain current awareness of their host laboratory accreditation and must advise the APVMA of any detrimental change to the accreditation within seven days of their becoming aware of the change. (A detrimental change would include reduced accreditation with respect to the details provided in support of approval as approved analyst.)
4. Sample integrity, receipt and notification (certificate of analysis), chain of custody and optimising recovery/detection
4.1 Once the test sample is received, the approved analyst is responsible for ensuring the integrity of the sample is maintained commensurate with the testing required. This includes the handling, storage and processing of the test sample. The approved analyst will ensure the samples are secure and free of contamination. Where Australian Standards apply, these must be followed.
4.2 Compositing of samples is strictly prohibited and all laboratory method limits of reporting are to be for single sample analysis only.
4.3 The approved analyst must register and acknowledge the receipt of a sample submitted for testing for purposes of national agricultural and veterinary chemicals law. Acknowledgement via email (to the APVMA contact officer or firstname.lastname@example.org) as soon as practicable and within 72 hours (three business days) of receipt of the sample is recommended.
4.4 The approved analyst is required to store all unused samples until advised in writing by the APVMA that the samples may be disposed, noting 4.1.
4.5 The APVMA may request for samples to be returned once testing is completed. The process for returning samples will be described in the contract. Under no circumstance are the samples to be simply posted to the APVMA.
4.6 All unused and partially processed samples should be disposed of in a manner that ensures the destruction of infectious agent where detected (noting 4.4). Where laboratories are handling quarantine material, they must be a Quarantine Approved Premise (QAP) as appropriate for that material (Class 5) and adhere to requirements for disposal of quarantine waste.
4.7 Documented traceability of the sample from receipt to destruction is to be maintained by the approved analyst at all times. All records are to be kept on file and made available to the APVMA or other relevant authorities upon request.
5. Sample analysis
5.1 The approved analyst must analyse the sample in accordance with the contract for testing. Testing of the sample for additional parameters must not be performed without prior agreement of the APVMA.
5.2 The approved analyst must perform or have oversight of the laboratory testing services to ensure they are completed with due care and professional skill and in accordance with the industry best practice, the scope of NATA accreditation and the APVMA contract for testing.
5.3 The equipment and materials used by the approved analyst for the purpose of providing services must be fit for purpose.
5.4 The approved analyst must test only a portion of the original sample with the remaining portion stored so as to ensure its integrity (see 4.1 and 4.4).
5.5 The approved analyst must be able to provide a detailed method summary to the APVMA on request.
5.6 The approved analyst must provide all details of analytical results (eg validation, chromatograms, sample preparation etc.) to the APVMA on request.
6. Invalid results and re-testing
6.1 Once the validity of a test result is confirmed, the approved analyst must immediately inform the APVMA contact officer upon suspicion that an incorrect, invalid or unusual test result has been reported, clearly stating the nature of the issue.
6.2 Where available information indicates that a test result is incorrect or invalid, the APVMA reserves the right to investigate the matter with the responsible approved analyst.
7. Confirmatory testing
7.1 Chemical testing: Where a test result fails to meet the standard or specified limits for the test (ie out of specification), this should be confirmed by a repeat analysis of part of the remaining portion of the original sample.
7.2 Microbiological testing: Where the test result means the sample will fail to meet the relevant standard or specified limits, the approved analyst must conduct an investigation to confirm that failures are not the result of contamination at the laboratory. The initial test results may be confirmed when the investigation has ruled out contamination or cross-contamination within the laboratory.
7.3 Pathogens: All presumptive positive results must be confirmed by a reference laboratory for serotyping where speciation is requested.
8. Reporting of results
8.1 The results must be provided to the APVMA in the form of a Certificate of Analysis (See Appendix 2).
8.2 The results should be provided within five days of completion of the testing or, if confirmatory testing is required, five days of conclusion of the confirmatory testing. The results may be provided electronically (scanned certificate) to email@example.com or by regular mail to the following address:
Compliance & Monitoring?
GPO Box 3262
SYDNEY NSW 2001
9. APVMA service procurement process
9.1 The Commonwealth Procurement Rules (CPR) apply to the procurement of analytical testing services by the APVMA.
10. Invoicing for tests where the APVMA is the client
10.1 The details for inclusion on any invoices to the APVMA will be included in the details of any contract offered by the APVMA. These would normally include details of substance tested, detail of tests performed, costs for each test, total cost including GST details, and dates the service was provided.
11. Sub-contract testing (will be subject to express permission in any APVMA contract)
11.1 The ability to sub-contract services will be subject to the express written permission of the APVMA and will normally be referred to in any contract for services.?
11.2 The approved analyst must ensure that any sub-contracting testing performed for the purposes of national agricultural and veterinary chemicals legislation is conducted by approved analysts in NATA accredited or APVMA approved laboratories, as per Section 56 of the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Regulations).
12. Record Keeping
12.1 The approved analyst must keep a copy of all records and other documentation (hard-copy or electronic) relating to the results, quality assurance procedures and analytical and testing methods for a period of not less than seven years.
13. Handling of Official Information
13.1 The approved analyst must comply with any reasonable requirements specified by the APVMA with regard to handling of official information.
13.2 For the purposes of establishing compliance with agricultural and veterinary chemicals laws the APVMA may need to disclose information that may be considered Commercial Confidential Information (CCI) to an approved analyst. The APVMA will clearly distinguish any CCI information. Persons who receive CCI information disclosed by the APVMA will be bound by provisions of the Agricultural and Veterinary Chemicals Code Act?1994.
13.3 If an approved analyst mistakenly receives information or a sample from the APVMA that is considered to be commercially confidential information, the analyst must immediately provide notice to the APVMA including a description of the information received in error. The analyst must document the receipt of the information and then return/destroy the information.?
14. Knowledge of Sections 97–99 of the Agricultural and Veterinary Chemicals Code Act 1994
14.1 The approved analyst should maintain current awareness of Sections 97–99 of the Agricultural and Veterinary Chemicals Code Act 1994.
15. Consultation on matters concerning the appointment as approved analyst and service conditions
15.1 The APVMA may revoke the approval of an approved analyst if the APVMA becomes aware of factors detrimentally affecting the analyst’s ability to meet the criteria for appointment (see 2.2).
15.2 An approved analyst will enable the APVMA to inspect the laboratory and/or record keeping facilities at a mutually agreed time.
15.3 The APVMA may review these guidelines and may amend them from time to time. Appointed analysts will be notified in writing of any changes made and should be able to demonstrate compliance with the revised guidelines within six months of such notification.
1Any future reference to NATA accreditation throughout this document is considered to include IANZ accreditation under the Mutual Recognition Arrangement whereby each national laboratory accreditation body recognizes the equivalence of accreditations granted by its overseas counterparts.