Guidance on quality requirements for biocides: Overview

On this page

• Purpose
• General
• Application requirements
• Quality control
• Investigation of complaints
• Contact us

Purpose

You are required to provide information in your biocide application so that the Minister of Health (the Minister) can determine if the biocide's benefits outweigh its risks taking into account any uncertainties relating to those benefits and risks. This requirement is set out in both the Food and Drugs Act (act) and Biocides Regulations (regulations).

This guidance document outlines the tools and approaches you can use to meet the quality requirements set out in the regulations so that biocides made available for sale in Canada are of good quality. Using these tools and approaches may reduce the number of times we need to clarify an item in an application. It will make a decision on your biocide more quickly.

This guidance is for people who work with biocides as:

• manufacturers
• packagers
• labellers
• testers
• importers
• distributors
• warehousing

You are responsible for ensuring that:

• you have information to support your biocide's quality (including stability)
• specifications and master formula for your biocide are established, followed and maintained (as defined in subsection 1(1) of the regulations)

You should contact us if you wish to deviate from the approaches in this guidance. If you do deviate from this guidance, you should include the following in your application, as applicable:

• scientific rationale
• scientific evidence or data to support your rationale
  • for example, an analysis of benefits and risks

When deviating from the described methods, standards and/or limits, you should provide:

• a description of the proposed limit, standard or method and
• a description of how you developed your proposed alternate limit or method
  • for example, sample analysis or quantitative estimate

General

If the Minister does not have sufficient information to conclude that the benefits of your biocide outweigh its risks, taking into consideration any uncertainties, we will either:

• request additional information or
• refuse to issue you a market authorization

Examples of situations where we may request additional quality information include:

• when we are aware of a quality concern related to the biocide
• if you have submitted the minimum application requirements, but there is insufficient information in your application for the Minister to make a decision
• when information in your quality summary shows there is a specific concern that should be investigated

Examples of additional quality information that could be requested to better characterize the benefits and risks of your biocide include:

• data
• description of methods (for example, if you're using in-house methods)
• literature
• written scientific rationale

For guidance on navigating the biocide application process, consult:

• Guidance on management of biocide applications
• Biocide application form user guide

The guidance on management of biocide applications outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application.

Application requirements

Information to support the risks and any related uncertainties of your biocide includes:

• quality information (when applicable)
• a quality summary (when applicable)

Certain applications must contain quality information and/or a summary of the information included in your application about the risks and any related uncertainties of your biocide. Find information below and in the guidance on biocide application pathways and general requirements on when quality data and/or a summary are required, and specific application requirements.

You do not need to include information on your biocide's quality if:

• you rely on the quality information of another authorized biocide and
• the quality information for your product is the same as the comparison product
  • such as product specifications, shelf life, stability and master formula

This applies to applications using the:

• comparison - administrative application pathway
• use of foreign decisions (UFD) pathway (except package description)
• comparison - labelling only pathway (except package description)

In all other application pathways, you must include the:

• shelf life
• product specifications (as defined in subsection 1(1) of the regulations)
• package description
• summary of quality information

As indicated in the summary of information on benefits, risk and related uncertainties section of the guidance on biocide application pathways and general requirements, the summary helps us screen and review your application. It may also reduce the number of clarification requests we issue, a mechanism outlined in the guidance on management of biocide applications.

Your summary should explain your biocide's quality, including a copy of your biocide's specifications, master formula and stability and shelf life results. It should include a summary of your quality data and other related information (such as rationales) for your proposed biocide.

If possible, you should put the quality summary in a table:

• a sample quality summary template is available

To support the shelf life of the biocide, you may need to provide stability information, including stability studies, in your application. This information may also be required for applications involving a different packaging from a comparison product (comparison - labelling only application) or foreign biocide (UFD application).

Refer to the stability and shelf life page for when stability data is required.

Certain biocides require additional quality information in their application for a market authorization. The Minister needs this information to determine if your biocide's benefits outweigh its risks, taking into account any related uncertainties.

Additional quality information is required for:

• novel biocides
• sterile biocides

Quality control

Relevant section of the regulations: sections 51, 52, 53 and 54

You are responsible for ensuring the quality control of your biocide, including:

• following the master formula (as defined in subsection 1(1) of the regulations)
• maintaining records that demonstrate compliance with the master formula
• specific manufacturing and packaging requirements for sterile biocides
• investigation of complaints in respect of the quality of the biocide

The quality of a biocide is an important factor in maintaining the effectiveness of a biocide, as failures in effectiveness can pose risks to health. Quality control is important to help mitigate these risks. The quality control requirements in the regulations provide a modern approach to ensure a final marketed biocide complies with the master formula, without the need for prescriptive regulations governing the manufacturing process.

Similar to the regulation of surface disinfectants under the Food and Drug Regulations, biocides are not required to obtain a drug establishment licence or meet good manufacturing practices (GMP) compliance. However, they are still expected to meet section 8 of the Food and Drugs Act (the act), which prohibits selling drugs manufactured under unsanitary conditions or that are adulterated.

To support compliance with quality control requirements in the regulations and the act, you should consult the information below. The updated recommendations build on the voluntary Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices (GUI-0049), published by the Regulatory Operations and Enforcement Branch of Health Canada and applicable for disinfectants regulated under the Food and Drug Regulations.

Master formula

Ensure both the manufacturing and the packaging operations are:

• covered by a master formula (as defined in subsection 1(1) of the regulations)
• prepared by a responsible individual trained in quality control/assurance and subject to independent checks.

We recommend that you maintain your master formula as a single continuous document or record.

The manufacturing master formula should include:

• a list of all raw materials to be used, and in what amounts, and any processing aids that may not be present in the final product (such as, solvents, catalyst, reagents) including their sources and preparation
• a statement of the expected final yield (along with the acceptable tolerance limits for all ingredients) and relevant intermediate yields (where applicable)
• specifications for all the materials as defined in subsection 1(1) of the regulations), including tests for identity and purity (such as, controls on impurities)
  • if applicable, the specifications should also include:
    • reagents
    • residual solvents and their upper limits
    • elemental impurities and their upper limits
    • mutagenic and carcinogenic impurities and their upper limits
    • tolerance limits for all ingredients
    • specified, unspecified and total impurities
    • impurities that can affect your final product, such as contaminants and potential isomeric impurities in the starting material
• detailed stepwise processing instructions (such as, checks on materials, pre-treatment, sequence for adding materials, mixing times, mixing speeds or temperatures, methods of calculation)
• description of critical manufacturing steps and the instructions for any in-process controls, along with their limits
• with regards to the equipment, the manufacturing master formula should identify the principal equipment to be used and provide the procedures (or reference to the procedures) to be used for preparing the critical equipment (such as, cleaning, assembling, calibrating, sterilizing)

The packaging master formula should include the following for each product, package size and type:

• packaging materials required for a standard batch size (including quantities, sizes and types of containers, closure systems and labels) and
• code or reference number relating to the specifications for each packaging material
• special precautions to be observed, such as a careful examination of the packaging area and equipment, including transfer lines and hoses
• description of the packaging operations, including any significant subsequent secondary operations and the equipment to be used
• detailed description of the methods used to test and examine the packaging material
• details of in-process controls, with instructions for sampling and acceptance limits
• statement of tolerances for the properties and qualities of the packaging material

Consult the section on product specifications and package description for more information on specifications.

Batch production record

Your master formula should also include blank spaces to record data during the biocide's production run to show that each manufacturing step has been completed. These blank spaces will capture:

• dates
• operators
• signatures
• lot numbers

Once you have filled out the master formula and attached supporting data, it becomes the batch production record. You should attach to the master formula supporting data, such as:

• cleaning records
• calibration dates
• list of equipment
• quality control results
• in-process test results
• test results confirming product is within authorized specifications

Records

If you're a market authorization holder, importer, manufacturer, packager, labeller or provide storage for a biocide, you must maintain records.

These records:

• must show that each lot or batch of the biocide that you sell has been manufactured, packaged, labelled and stored in accordance with the master formula for the biocide depending on your activity
• are not required to be submitted with your biocide market authorization application

If you are a market authorization holder or importer, you must maintain records that show that each lot or batch of the biocide that you sell has been manufactured, packaged, labelled and stored in accordance with the master formula for the biocide depending on your activity.

If you are a manufacturer, or a packager or labeller, you must maintain records that show that each lot or batch of the biocide that you sell has been manufactured, or packaged and labelled, depending on your activity, and stored in accordance with the master formula of the biocide.

You should have the following documentation:

• master formula with the written specifications of the raw material and/or the packaging material and evidence that all materials have been tested or examined according to those specifications (as defined in subsection 1(1) of the regulations)
• evidence that each batch or lot was manufactured, packaged, labelled, tested and stored according to the master formula and market authorization
  • manufacturers and packagers must have complete records of all manufacturing and packaging activities
• testing establishing the shelf life of biocide
• finished product testing
  • evidence of compliance with finished product
  • specifications for each lot of the biocide
• records of equipment calibration and
• certificate of analysis

For records of testing, these should indicate the actual results, methods used and laboratory where testing was done.

Records for packaging material testing should be maintained for packaging components that are:

• used for biocide delivery or application
• necessary to ensure biocide quality during transportation, excluding shipping cartons
• used as a protective barrier to help ensure stability or sterility of the biocide and
• in direct contact with the biocide
  • for example, container, closure, liner, desiccant

Documentation may be paper-based, electronic or photographic media.

For information on electronic records, consult PIC/S Annex 11: Computerised systems (adopted by Health Canada). This guidance explains Part C, Division 2 of the Food and Drug Regulations and is not mandatory for biocides.

Records:

• must be reliable, complete, consistent and accurate
• should be legible, with no parts of the data obscured or removed
• if archived, they must be retrievable in a timely way
• If changed, these changes should also be documented and traceable

Retention period

If you are the market authorization holder, importer or seller (even if you stop engaging in these activities), you must keep records and evidence for at least:

• 1 year after the last day of the month in which the shelf life of the biocide expires or
• 6 years after the day on which they sold the biocide (if shelf life unknown)

Requirement to provide information

Quality records are not required to be submitted with your biocide market authorization application.

If you are the market authorization holder, importer or seller, you must provide us with quality records when we request them within 5 business days or less as specified.

Documentation must be in English or French.

Personnel

The appropriate personnel with sufficient training are necessary to manufacture, package, import or store biocides of high quality. You should employ qualified personnel to supervise the manufacturing, packaging, labelling, importing and storage of biocides.

These recommendations can help maintain the quality of your biocides, as inadequate qualification or training of personnel may lead to the failure of a biocide to meet its specifications and its quality requirements.

Personnel qualifications are not required to be submitted with your biocide market authorization application.

Qualifications

Individuals in charge of manufacturing and quality control should have adequate education, training and/or practical experience to control and/or supervise activities. This can include:

• graduation from a university of recognized standing, with a science degree or
• an appropriate combination of scientific and technical qualifications, with at least 2 years of relevant practical experience in formulating or testing biocides or other types of drugs

Individuals in charge of manufacturing and quality control may also delegate their duties to other persons with proper education, training and/or experience.

To ensure that operations involved in the handling of biocides are properly performed, all personnel should have adequate qualifications, including training and/or experience. This includes individuals responsible for:

• packaging operations, including control over printed packaging materials and withdrawal of bulk substances
• quality control in distribution and import operations and
• all equipment and machinery

A variety of documents can provide evidence of sufficient training and/or experience necessary to perform assigned duties, including:

• resume or C.V.
• copy of educational degrees
• job descriptions
• certificates of completion
• employee training schedule and/or attendance records

Premises

Buildings where a biocide will be manufactured, packaged, labelled, imported and/or stored should be designed and constructed in a manner that permits cleanliness and orderliness, while preventing contamination. Regular maintenance will also help to prevent deterioration of the premises.

The objective is to ensure products do not become contaminated through unsanitary conditions.

These recommendations can help prevent the contamination of biocides by other products, dust, cleaning agents or foreign materials.

Specific information on premises is not required to be submitted with your biocide market authorization application.

Building design

You should design, construct and maintain your premises to prevent the introduction or migration of extraneous materials, insects or other animals into biocides. An appropriate building design can help you ensure activities related to biocides are being conducted in a sanitary way. This includes:

• establishing water systems that prevent contamination (for example, use of traps)
• adequate light and ventilation to prevent accidents in working areas
• sufficient space between walls and equipment to facilitate cleaning
• properly installed outlets for liquids and gases and
• adequate rest, change, washing up and toilet facilities that are separate from production areas

Designated spaces

Clearly designated spaces can prevent cross-contamination where different activities are being conducted in the same building. Production and non-production areas should:

• be separated by intact doors that are adequately sealed
• be segregated by activity
• be clearly marked to quickly identify location and
• limit access to authorized personnel, if necessary

Regular maintenance, verification and monitoring of the facility and equipment can reduce the likelihood of contaminants introduced into the environment being transferred to products. This includes:

• removing dust, powder or other contaminants on equipment regularly
• replacing old parts (such as air filters and traps)
• testing water quality regularly
• monitoring pressure differentials performed, when applicable
• monitoring daily temperature, relative humidity and light (as required)
• avoiding temporary means for repair (for example, tape or cardboard)
• ensuring that floor drains are screened and trapped and
• minimizing uncleanable surfaces

Equipment

Contamination issues may arise from inadequate cleaning practices, poor maintenance, misusing equipment, exceeding the capacity of equipment and using worn-out equipment. These recommendations can help prevent the contamination of biocides by other products, dust, cleaning agents or foreign materials coming from the equipment.

Specific information on equipment is not required to be submitted with your biocide market authorization application.

Equipment that's arranged in an orderly manner allows for effective cleaning and prevents interference with other processing operations. It also minimizes the circulation of personnel and optimizes the flow of materials.

All processing, packaging and testing equipment should be designed and located in a way that permits ready and thorough cleaning, sanitizing and inspection. This includes:

• being made of materials and construction that will not contaminate or add extraneous materials to biocides
• ensuring proper design to avoid the possibility of lubricant or other maintenance materials contaminating the biocides
• being designed to withstand repeated cleaning
• ensuring production equipment and utensils with direct contact with materials and biocides are constructed of smooth, non-reactive and non-toxic materials and
• installing or placing analytical instruments and associated control systems in areas away from vibration, electrical interference and contact with excessive moisture or other external factors

Establishing and following procedures for cleaning and maintaining equipment can help you ensure the equipment remains in a good state of repair when in use to prevent contamination of the biocide. Procedures should include:

• calibrating scales and other measuring equipment used in production and control on a scheduled basis
• checking and calibrating automated, mechanical, electronic or any other types of equipment used in production at defined intervals
• maintaining records of equipment cleaning and calibration
• avoiding temporary repairs and
• clearly labelling defective equipment as such

Investigation of complaints

Relevant section of the regulations: sections 48, 49, 50, 51, 52, 53 and 54

As part of its regulatory responsibilities, the Regulatory Operations and Enforcement Branch of Health Canada monitors compliance, undertakes enforcement actions, and works towards preventing non-compliance through compliance promotion activities. The interpretation of the scope of the compliance and enforcement policy for health products (POL-0001) has been expanded to include biocides.

If you receive a complaint about the quality of the biocide, you must document and investigate it and, if necessary, take corrective action. This applies to authorization holders or importers, as well as manufacturers, packagers or labellers of a biocide.

When investigating complaints, suspected product defects and other problems related to the quality of the biocide should:

• apply an appropriate level of root cause analysis
• include the following in the investigation of complaints that indicate a potential product quality defect:
  • a description of the reported quality defect
  • a determination of the extent of the quality defect and potential for other batches or products to be impacted
  • an evaluation of samples of the defective product from the complainant or the use of other appropriate strategies if samples are not available
  • distribution information for the batch in question
  • an assessment of the risks posed by the quality defect
  • a defined decision-making process to implement risk mitigation strategies, where appropriate
  • a description of the internal and external communications that should be made about a quality defect and its investigation and
  • the identification of the potential root cause of the quality defect
• identify and carry out, in a timely and effective way, the appropriate corrective actions and/or preventive actions (CAPAs) to address the product quality issues
• monitor and assess the effectiveness of your actions

When a decision is made to recall a product, you must notify Health Canada as per section 49 of the regulations. For additional information on recall requirements, refer to the Drug, natural health product and biocide recall guide (GUI-0039).

Where required, you should have an agreement in place between the various parties involved in investigations and corrective actions (importer, market authorization holder, manufacturer, packager or labeller). This agreement should define each party's responsibilities in assessing quality and taking any corrective and preventative actions.

Such agreements cannot be used to transfer your obligations under the regulations. If an agreement is in place, the person responsible for the activity should be clearly spelled out.

Records - complaints, investigations and corrective actions

If you are the authorization holder, importer, manufacturer, packager or labeller of a biocide, you must maintain a record of each complaint, investigation and any corrective action taken.

You must maintain records of:

• complaints or any information about the quality of a biocide or its deficiencies or hazards (should include all original details)
• follow-up investigations, including corrective actions taken and
• decisions and measures taken as a result, with reference to the corresponding batch records

You should review complaint records regularly to check if specific or recurring problems are occurring and need attention.

Retention period - records of complaints, investigations and corrective actions

If you are the authorization holder, importer, manufacturer, packager or labeller of a biocide, you must retain and maintain each record of each complaint, investigation and any corrective action taken. This applies even if you no longer hold the market authorization or no longer import the biocide.

Records must be maintained for at least 1 year after whichever is later:

• last day of the month in which the shelf life of the lot or batch of the biocide to which the complaint relates expires or
• day when the investigation is completed if no corrective action is taken or
• day when the action is completed if corrective action is taken

If ownership has been transferred, the new market authorization holder must retain records of investigations and corrective actions that were sent to them.

Requirement to provide information - records of complaints, investigations and corrective actions

If you are the holder of the market authorization, importer, manufacturer, packager or labeller of a biocide, you must provide records of complaints, investigations or corrective actions upon request. They must be provided within 5 business days or less.

We will ask for records sooner if we have reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

Contact us

Contact the Natural and Non-prescription Health Products Directorate to:

• request pre-submission advice or set up a pre-submission meeting
• discuss the appropriate quality information you may need to support your biocide
  • for example, the additional quality information for a novel biocide
• discuss alternative quality test methods or modifications for your biocide

Email: nnhpd-dpsnso@hc-sc.gc.ca