Guidance on quality requirements for biocides: Quality summary
On this page
- About the quality summary
- Section A: Quality information for all biocides
- Section B: Additional information that may be requested
About the quality summary
Certain applications must contain a summary of the information included in your application about the risks and any related uncertainties of your biocide, including for quality information. Find information in the guidance on biocide application pathways and general requirements on when a quality data summary is required.
Your quality summary should summarize your biocide's specifications and stability and shelf life results.
Your quality summary should contain a copy of your specifications (as defined in subsection 1(1) of the regulations), which includes a:
- reference number, version and date for version control purposes
- signature and date from a responsible individual trained in quality control and assurance
Do not include detailed information on quality data reporting in your summary. The quality summary should include a summary of the quality reports submitted in support of your biocide.
If you're using in-house methods, your quality summary should include:
- a description of the method
-
literature reference to the origin of the method, if applicable
- for example, HPLC method; Hoffmann, J.L. (1986) Biochemistry 25: 4444-4449
If you do not know the chemical identity or chemical composition of an ingredient because it's proprietary or trade secret information, you must ensure the supplier or producer of the ingredient provides this information.
Example of a summary template for quality information
To summarize your quality information for a biocide, use:
- the following template or
- a different format that contains the same information
Section A contains information that all quality summaries for biocides should include.
- Information provided within the biocide application form should not be repeated within your summary, unless you are providing additional information for our awareness.
Section B contains additional information we may ask to be included in the quality summary (for example, for novel biocides and sterile products).
Section A: Quality information for all biocides
Biocide information
| Aspect | Description |
|---|---|
| Company (applicant) name and address | |
| Primary brand name | |
| Method of application | |
| Settings for use | |
| Single or multiple formulation |
Product specifications
Biocide formulation information
Active ingredients:
Provide the following information for each active ingredient within the biocide.
| Aspect | Description |
|---|---|
| Chemical and common name (if any) and trade name, if applicable | |
| Chemical Abstracts Service (CAS) registry number | |
| Nominal concentration (%w/w) of the biocide (potency) | |
| Upper and lower tolerance limits (%w/w) within the biocide | |
| w/w: weight per weight | |
Biocide potency and pH testing:
Provide the following information for your finished biocide.
- Guidance on batch replication requirements is provided in the ingredient tolerance limits and nominal concentrations section.
| Batches tested | Method used | Concentration of active ingredient in the tested batches |
|---|---|---|
| Batches tested | Method used | Measured pH |
|---|---|---|
Formulants:
Provide the following information for each formulant within the biocide.
| Aspect | Description |
|---|---|
| Chemical and common name (if any) and trade name, if applicable and known | |
| CAS registry number | |
| Nominal concentration (%w/w) in the biocide (potency) | |
| Upper and lower tolerance limits (%w/w) within the biocide | |
| w/w: weight per weight | |
Impurities:
List all potential impurities.
For each impurity associated with the biocide and its active ingredients and formulants that are toxicologically significant, provide:
- an upper tolerance limit and
- a scientific justification describing how the proposed limit was determined, based on the:
- toxicological profile of the impurity and
- exposure of the user (consider all relevant routes of exposure and intended uses)
| Impurity identification | Chemical name of impurity | Nominal concentration of impurity | Tolerance upper limit or rationale if not included in the product specification for routine testing |
|---|---|---|---|
Stability information
Summary of stability protocol
| Protocol parameter | Description |
|---|---|
| Real time, accelerated or in-use? | |
| Storage conditions (for example, temperature, humidity) | |
| Testing frequency | |
| Number of batches | |
| Tests and acceptance criteria | |
| Other (for example, physical changes) | |
| Summary of results obtained |
Stability factors
List any factors that would affect the efficacy and stability of the biocide (for example, the presence of certain formulants, impurities, temperature, pH, UV light)
- factor 1
- factor 2
- factor 3
Section B: Additional information that may be requested
Biocide formulation information
Active ingredients
Include:
- a detailed description of the active ingredients, such as:
- particle size
- molecular mass
- molecular formula
- chemical structure
- including relative and absolute stereochemistry
- a description of how the active ingredients exhibit antimicrobial properties
- additional physical properties, such as:
- solubility
- thermal stability
- evaporation rate at room temperature
- dissociation constants
Impurities not routinely tested
Describe the impurities that may be present in the biocide and why they may be present. Your description should include:
- potential impurities that you're not proposing for routine testing
- impurities tested during development but the testing was sufficient to support that routine control is not necessary (rationale required)
- impurity associated with the active ingredient that you determined to be toxicologically significant or present in any sample at a level less than or equal to 0.1% by weight of the technical grade active ingredient
You should base this description on:
- established chemical theory and
- what you know about the starting materials, technical grade of active ingredient, formulants and production or formulation process
| Impurity identification | Nominal concentration | Upper tolerance limit | Rationale |
|---|---|---|---|
Degradation products and substances of concern
List all degradation products (including CAS numbers) associated with the end-use formulation or any substances of concern (such as, analysis of N-nitroso contaminants).
| Chemical and common name (if any) and trade name, if applicable | Quantity | Chemical Abstracts Service (CAS) registry number |
|---|---|---|
Manufacturing information
Batch formula (name, physical form)
List of all components of the physical form you will use in the manufacturing process and their amounts on a per batch basis (including overages, if any).
| Aspect | Description |
|---|---|
| Strength (label claim) | |
| Master formula (as defined in subsection 1(1) of the regulations) Reference number (and version, if applicable) |
|
| Batch size (number of dosage units, if applicable) | |
| Component and quality standard (and grade, if applicable) | Quantity per batch |
| Total |
Batch analyses
You should provide certificates of analyses or a tabulated summary for:
- at least 2 batches from each proposed commercial manufacturing site
- batches used in pivotal studies
Description of manufacturing process and process controls (name, manufacturer)
Your description should include a:
- flow diagram of the manufacturing process showing reactants, solvents and reagents
- narrative description of the manufacturing process, including equipment type and working capacity, process parameters
- the description should be based on the details listed in the master production documents for the commercial batch size
- summary of controls performed at the critical steps of the manufacturing process and on isolated intermediates
- list all in-process controls routinely monitored for production batches
- identify the critical equipment and process parameters that can affect the quality of the biocide
- define testing parameters, sampling plans, analytical procedures and acceptance criteria
Methods information
| Aspect | Description (type of method, range, LOD, LOQ, precision, accuracy) |
|---|---|
| Method used to test active ingredient | |
| Method used to test impurities | |
| Other methods discussed in your submission | |
| LOD: Limit of detection LOQ: Limit of quantification |
|
Special considerations
Also include any additional quality documentation that we requested during pre-submission consultation.