Paper , Order, or Assignment Requirements

How is this product made? GMP? How are you maintaining a consistent product?

What kind of testing/analysis?

Using what equipment? How is the equipment used?

Cleaning and validation of equipment

any changes to the formulation process and quality control steps

batch analysis data, stability data, full details of the analytical method(s) used

appropriate validation data for the analytical method(s).

Labelling criteria – A chemical product meets the labelling criteria if the label contains adequate instructions relating to the following as appropriate:

the circumstances in which the product should be used

how the product should be used

the times when the product should be used

the frequency of the use of the product

the withholding period after the use of the product

the re-entry period after the use of the product

the disposal of the product when it is no longer required

the disposal of containers of the product

the safe handling of the product and first aid in the event of an accident caused by the handling of the product

any matters prescribed by the Agvet Code Regulations, including:

for a chemical product that is a veterinary chemical product, the duration of any treatment using the product

the prevention of undue prejudice to trade or commerce between Australia and places outside Australia

the appropriate signal words (if any) required by the current Poisons Standard

for a chemical product that is a date-controlled chemical product, the storage of containers for the product

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The idea of all work of make you understand what work I would do on it

The Scenario

Growing evidence is demonstrating that many useful pesticides are producing unacceptable harm.

Your company has produced an engineered nanoparticle that greatly enhances pesticide effectiveness by:

• Reducing spray drift
• Enhancing toxicity to target organisms
• Protects against premature degradation
• Inhibits dispersal from the target site

This is a platform technology but your initial launch will partner with the manufacturer of diuron.

This is because:

• It has significant global sales
• Its effects are well studied
• Unwanted effects are threatening its future
• Its effects on World Heritage Sites such as the Great Barrier Reef give it a high profile

You must produce a strategic report to develop information and experimental results to support a timely and economic registration process by the APVMA. Delays will not only be expensive but may undermine market confidence in the superior safety of the nano-product.

Some point should cover in all work

What steps should you consider for establishing effects on human health?

How will you demonstrate effectiveness for purpose?

What issues are critical to demonstrate its superior environmental credentials?

How will you demonstrate its safety to animals?

What are the international trade implications?