Pest Management Regulatory Agency Statement of Product Specification Form

With described video

Transcript

Transcript

Narrator:

Text on screen says, What is the Statement of Product Specification Form (SPSF)?

Narrator:

This form lists all of the ingredients and their levels in a pest control product. It must be submitted to PMRA when you want to register or amend a pest control product.

A statement of product specification form appears on screen, zooming from top to bottom.

It is designed for reporting the composition of all four types of products:

Various chemicals in bottles, flasks and test tubes appear on screen

Text on screen says, Technical Grade of Active Ingredient, Integrated System Product, Manufacturing Concentrate and End-use product with various chemical and product icons.

Narrator:

Let's take a look at some specific areas for completing the SPSF for technical-grade products.

The statement of product specification form appears on screen. Text to the right of form slides in that says SPSF.

For the manufacturing site, enter the name and address. This must be the physical address, not a P.O. Box or corporate headquarters.

The form zooms in on the name and address section (box O). Text populates a placeholder address on the form.

But remember, each manufacturing site requires a separate SPSF, even if specifications are identical. So, make sure you do not check this box for TGAIs or ISPs.

Several SPSF forms appear on screen. Text appears overtop of the forms that says, each manufacturing site needs a separate SPSF.

The extra forms disappear, and the form zooms back onto the name address section. Text appears overtop that says, do not check this box for TGAIs or ISPs.

Narrator:

Next, enter the formulation type code, formulation and version numbers. The formulation type is taken from the SPSF guidance. The formulation number increases every time a new site of manufacture (source) is added. The version number increases when the specifications of the source are updated.

The form zooms in on the formulation type code, formulation number and version number sections of the form. The sections are highlighted and outlined in red indicating they are being referred to.

Now, let's take a look at how to identify the active ingredient. Its common name usually appears on the product label.

Text appears that says, how to identify the active ingredient. A product in the form of an aerosol can with the word genuconazole written on it appears to the left.

The text disappears and the product becomes full screen.

Enter the common name of the active.

The SPSF form appears, zoomed in on the Common Name section. The box is outlined in red and populated with the name Genuconazole.

Enter the CAS or IUPAC systematic chemical name.

The Chemical name field is now highlighted and populated with a chemical name.

Then, enter the CAS Number associated with the active.

The CAS Number field is now highlighted and is populated with a number.

Add 'active ingredient' as the purpose.

The purpose field is highlighted and is populated with text that says active ingredient.

Narrator:

Now, let's look at product guarantee.

You'll need to enter the nominal specification associated with the manufacturing site in Boxes 9 and 12.

Box 9 and 12 on the form are highlighted. The number 98 populates both fields.

Then the lower certified limit or LCL.

And the upper certified limit or UCL. These should be the standard certified limits as you'll see in the guidance.

The lower certified limit field and upper certified limit fields are highlighted and populated with a number. Text on screen appears over the form that says, common deficiency.

Finally, enter the overall label guarantee and certified limits If there are several sites, the guarantee may be slightly different from the specifications for this site but must be the same for all sites under this registration number, and all sites must fit within this label guarantee.

The label guarantee field is highlighted and populated with text that reads genuconazole. Four fields below indicating certified limits are highlighted and populated with numbers.

Various chemicals in bottles, flasks and test tubes appear on screen. Text appears that says, each site under the same registration number must have the same label guarantee of the active ingredients.

Narrator:

Sometimes, an active ingredient can be present in another form, such as a salt or ester. In this case, the label guarantee will show just the active portion.

All of the chemicals disappear except for a round flask holding a green liquid. Text at the top of the screen says different forms of active ingredients. Lines appear connecting words to the flask that read salt, amine and ester.

To enter the specifications, enter the name of chemical form actually present.

The SPSF form appears on screen. The common name and chemical name fields are highlighted and outlined in red. They are populated with chemical names.

Then enter the weight % associated with this chemical.

Box 9 is highlighted on the form and populated with a number.

Next, enter the specifications of this chemical.

Boxes 11, 12 and 13 are highlighted and populated with numbers.

And the label guarantee that refers to the active portion only.

The label guarantee section is highlighted and populated with text and numbers.

Take a look at a few more examples of active ingredients present in various forms.

A wider view of the form appears with the chemical name field and label guarantee field highlighted and outlined in red.

A second form appears with the same highlighted fields, displaying different populated information as an example.

Narrator:

Next, we will look at how to enter information about TGAI impurities.

Text on screen appears that says, how to identify and enter information about TGAI impurities.

But first, it is important to remember that all impurities of toxicological concern must be specified if they are detected, even if below 0.1%.

The SPSF form appears. Text appears over top of the form that says common deficiency.

If possible, always give the impurity "code name".

And a valid CAS or IUPAC chemical name.

The form zooms in on the "components" area of the form. Boxes 10, 2 and 3 are highlighted and populated with text and chemical names.

Here, you need to enter a valid CAS number. But impurities without an associated CAS number will be blank.

Box 7 is highlighted. Text appears over top of the form that says if there is no CAS number, leave it blank.

Then enter the weight %. This is calculated by taking the average level from the 5-batch data for the manufacturing site. Here, the mean of these 5 values were taken to get the weight %.

Box 9 is highlighted and populated with a number. A table appears to the left. The table has measured concentration values and sample ID values.

Narrator:

Also, make sure the UCL reflects either a manufacturing specification or the highest level expected in production.

Box 13 of the form is highlighted.

This level can be calculated by taking the average value of the batch data plus 3 times the standard deviation.

A pencil and calculator appear on screen. In between, text appears that says UCL calculation formula. UCL equals zero point five plus three times the standard deviation.

This is best done using software such as Excel.

An Excel form appears on screen with an example of a calculation.

If you set the UCL of an impurity to the maximum from the 5-batch analysis, that leaves no leeway for manufacturing variation.

Box 13 is highlighted and populated with the number 0.15. Text appears over top of the form that says common deficiency.

Narrator:

Remember the sum doesn't need to be 100% for a TGAI but must be at least 98.5.

The sum section of the form is highlighted and is populated with the number 98.5.

And last but not least, sign the SPSF and date it. Digital signatures are allowed.

The certification of approving official section is highlighted.

Narrator:

For more information and to request the SPSF and associated guidance, contact the Pest Management Information Service.

The Health Canada logo appears on screen and text says, for more information and to request the SPSF and guidance, contact the Pest Management Information Service.

E-mail: hc.pmra.info-arla.sc@canada.ca

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