Data Assessment Report for
Vertebrate Toxic Agents
Chemistry and Manufacturing

For new applications, complete this entire form.

For variation applications, complete the relevant sections.
1
2
Identity
1.1
Applicant:
1.2
Trade name:
1.3
Registration number (if known):
1.4
Application type:
Chemistry
2.1
Formulation type:
2.2
Formulation of the trade name product:
List all ingredients (active ingredient(s) and non-active ingredients) by their CAS number and
chemical/common name with their concentrations and functions. For variations, specify existing and
proposed formulations.
Ingredient name
(common or chemical)
2.3
CAS number
Composition
(g/L, g/kg)
Manufacturer of active ingredient(s) provided:
Function
<yes/no>
Manufacturer details.
2.4
Specifications of active ingredient(s) provided:
<yes/no>
State the purity. If required, also state whether the active ingredient(s) conform to recognised
standard and discuss any other issues relating to specification.
AC-AFT-81-5C.1
January 2013
2.5
Batch analysis of active ingredient provided:
<yes/no>
2.6
Impurities associated with active ingredient(s) stated:
<yes/no>
List significant impurities and state if they are within prescribed limits.
2.7
Specifications of non-active ingredient(s) provided:
<yes/no>
Are recognised standards nominated or internal methods provided?
State purity and discuss any other issues relating to specification as required.
2.8
Release specifications of product:
List.
3
Manufacturing
3.1
Manufacturer(s) of the formulated product:
Manufacturer details.
3.2
Manufacturer(s) approved by ACVM (GMP Standard):
<yes/no>
List approved class of products. Indicate if the manufacturer is approved by authorities in other
countries.
3.3
Manufacturing process described:
<yes/no>
Describe process and note any issues.
3.4
Full details of the quality control procedure given:
<yes/no>
List tests conducted. Are the procedures adequately described in accordance with the Chemistry and
Manufacturing Information Requirements? State analytical methods used and comment on validation
either with recognised standards or company specified methods.
3.5
Batch analysis of product provided:
<yes/no>
Summarise results.
3.6
Packaging specifications provided:
<yes/no>
State pack sizes and packaging material. Are they adequately described in accordance with the
Chemistry and Manufacturing Information Requirements?
4
Stability
4.1
Proposed shelf life:
State the proposed shelf life.
4.2
Label storage statement:
Copy from the label.
4.3
Expiry specifications:
List.
4.4
Overage:
Is an overage used at manufacture? Discuss in relation to the known stability of the active ingredient.
4.5
Risk assessment:
AC-AFT-81-5C.1
January 2013
Describe the data and argument presented with reference to the Chemistry and Manufacturing
Information Requirements, including number of batches, test storage conditions, parameters
measured and length of stability trial. The argument may involve referencing other data packages. If
an information waiver was granted, indicate whether it was justified. Does the complete package
support the proposed shelf life? Estimate the likelihood of instability occurring, and discuss the
possible consequences with respect to risk areas managed under the ACVM Act.
5
Conformance
Identify and discuss any issues relating to lack of conformance with the Chemistry and Manufacturing
Information Requirements.
6
Recommendations of the data assessor
6.1
Confirmation:
Confirm that the data package is sufficient to identify the product and give an assurance of quality.
6.2
Shelf life:
State the shelf life you believe is supported.
6.3
Amendments and/or conditions:
State any label content amendments and/or additional conditions that you recommend.
Assessor's name:
Signature:
Date signed:
Time taken for assessment:
AC-AFT-81-5C.1
January 2013