Record Monitoring
The APVMA Officer will check to determine if the product has:
- been supplied,
- at the time of supply the active constituent, or other constituent if relevant, contained in the product complied with the APVMA Standard Conditions of Registration, and
- the manufacturer of the active constituent, is listed on the Record of Approved Active Constituents.
During the review, some or all of the following information will be assessed:
- Name of the active constituent.
- Name of the manufacturer of the active constituent.
- Address of the manufacturer of the active constituent.
The APVMA Officer will check the details in 1 to 3 against the Record of Approved Active Constituents
- Batch number of the active constituent.
- Date of manufacture of the batch of the active constituent.
- Date of analysis of the batch of the active constituent.
- Results of analysis.
The APVMA Officer will check these results for compliance with the APVMA standard for the active constituent.
- Method of analysis or a reference to the method.
- Validation data for the method of analysis or a reference to that data.
The APVMA Officer will check the details in 8 and 9 to determine if the results of analysis are reliable.
- The AC batch analysis results are being retained for a period of 2 years.
- The full name of the Chemical Product.
- The APVMA product number for the Chemical Product.
- The name and address of the importer or the Australian manufacturer for the Chemical Product.
- The date of importation or manufacture for the Chemical Product.
- The batch number for the Chemical Product from which the supply was made.
- The batch number and name and address of the manufacturer of the active constituent contained in the product
This information will be checked to determine if the active constituent contained in the product complies with the APVMA Standard and was manufactured at a site listed on the record of Approved Active Constituents).
- The product records are being retained for a period of 2 years.
Verbal explanations or interpretations for record discrepancies cannot be accepted in place of written records. Monitoring will only be based on objective evidence that speaks for itself.
If more than one document is relied on to establish information a link between the documents must also be established. (for example if an analysis certificate does not have the date of manufacture of a batch but the manufacturing records do then a link such as a batch number on both documents will be needed to establish the link.) Failure to establish a clear trail for validity of information will result in the failure of the records to comply with the conditions of registration.