Instructions for Completing the Quality Assurance Report Form

Applicants must complete the Quality Assurance Report (QAR) Form to self-assess their operations against the requirements of Part 3 (Good Manufacturing Practices) of the Natural Health Products Regulations and relate to the Good Manufacturing Practices (GMPs) for Natural Health Products Guidance Document.

Applicants must complete one report per building or location at the same address, and the report must be completed by a person that has the necessary qualifications to assess the operations of the facility.

Please submit two copies of the QAR form, one original and one photocopy.

General Information

Box #

1 Define the type of submission by checking off one of the following boxes:

• Site licence Application. First-time applications
• Amendment. Submission for amendment
• Renewal. Submission for renewal

2a Date of the last inspection at the building identified in box # 3

2b Type of inspection:

• Self inspection - inspection was conducted internally
• Third party audit - inspection was conducted by an independent person(s) or organization
• Regulatory Agency - report from a governmental body, such as Health Canada or inspection reports from another country
• Other - any other type of audit

3 The registered name of the building

4 Building refers to one location, one address. When an applicant carries out activities in more than one building at different addresses, a QAR must be completed for each address. Designate each building in numerical order (e.g. 1, 2) and complete the respective sections of the form. When one site has more than two buildings, add the required information for the additional building as an attachment.

5 Indicate whether the building is a place of residence.

6 - 10 Street address, city/town, province/state/ postal/zip code, country where the building is located.

11 The activity that is being performed or will be performed in this particular building is: manufacturing, packaging, labelling and/or importing non-sterile natural health products.

12 The activity that is being performed or will be performed in this particular building is: manufacturing, packaging, labelling and/or importing sterile natural health products. A s terile dosage form is free from microbial contamination. Note: Manufacturers, packagers, labellers, importers and distributors must treat all sterile natural health products in the same manner as any other sterile health product. Follow the guidance provided in the guidelines published by Health Canada's Health Products and Food Branch Inspectorate and Therapeutics Products Directorate. The latest version of this document is available.

13a The activity that is being performed or will be performed in this particular building is: manufacturing, packaging, labelling and/or importing homeopathic medicines.

13b When manufacturing, packaging, labelling and/or importing homeopathic medicines a Supplementary QAR form should be completed and attached, in addition to the QAR. Please check off this box to indicate that the Supplementary QAR has been attached.

14 The final physical form of the natural health product that may be used by the consumer without requiring any further processing. Note: Applicants are not limited to using dosage forms on the list provided at the end of the instructions.

15 Identify product type from the following list:

• Plant, alga or fungus
• Non-human animal material
• Bacterium (non-living, e.g. tyndallized, spirulina)
• Extracts
• Isolates
• Enzymes
• Vitamins
• Minerals
• Amino acids
• Essential fatty acids
• Synthetic duplicates
• Probiotics
• Homeopathic medicines

16a Refers to Section 28 (f) of the Natural Health Products Regulations. The name of the Quality Assurance Person (QAP) who completed the QAR for the building listed in box #3 of this form.

16b The QAP identified in box #16a is an in-house * QAP or is a third party (auditor) who is independent of the company he/she is auditing and who is qualified by education, training, and technical knowledge to conduct a natural health product good manufacturing practices site audit. * In-house - Something that is done within an organization or business by its employees rather than by other people. The person identified in box #16a is the individual who is required to sign the Attestation of the QAR.

17a The name of QAP who is responsible for ensuring Section 51 of the Natural Health Products Regulations ( approving the materials , methods and procedures; approving product release for sale and resale; and investigating and recording complaints) is maintained. Note: the person identified box # 17a could be the same person as identified box # 16a.

17b The QAP identified in box #17a is an in-house QAP or is a third-party quality assurance person who is independent of the company he/she is conducting the QA activities for and who is qualified by education, training, and technical knowledge.

Detailed Report

Part 3 (sections 43 to 62) of the Natural Health Products Regulations sets out the good manufacturing practices (GMPs) that manufacturers, packagers, labellers and importers must meet before a site licence for each location will be issued in order to allow the sale of natural health products in Canada.

Statements/Questions: Yes/No

The statements/questions in this report are divided into the following four (4) sections in accordance with the Good Manufacturing Practices guidance document: Places (premises and equipment), People (personnel and quality assurance), Processes (sanitation program and operations) and Products (specifications, stability, samples, records, recall reporting and sterile products).

Check off the response to the statement/question as either YES that statement/question is correct or NO that the statement/question is not correct. If the statement/question is unclear, refer to the appropriate section(s) in the GMP guidance document for assistance.

If yes is answered to the statement/question, in the space provided clearly describe how the site complies with the referenced section of Natural Health Products Regulations.

If no is answered, in the space provided provide a clear rationale as to why the statement/question is not applicable to the activities conducted at the site.

Note: Additional pages may be attached if the space provided is not sufficient. Identify in the "list of attachments" under the Supporting Documentation the additional pages that have been attached.

Standard Operating Procedures (SOPs)

An SOP is an authorized written procedure giving instructions for performing operations, and are not necessarily specific to a given product or material but of a more general nature. SOPs can be defined as established methods to be followed routinely for the performance of designated operations or in designated situations. These are concise and specific step-by-step instructions that allow an individual with limited knowledge or experience on the procedure to successfully reproduce the activities. Certain SOPs may be used to supplement product-specific master production documents.

For each statement/question, the applicant is required to list the title(s) and the number(s) of the relevant standard operating procedure(s) that are in use at the site.

Example: FACIL-001 - Pest Control

Note: The actual SOP(s) does not need to be attached, unless the applicant feels that the SOP(s) will help in the assessment of the site licence application.

For each SOP listed, a copy of any record/log/checklist should be attached as supporting documentation to show that the SOPs that are listed are being followed on a daily/monthly/annual basis.

Records should be completed (not blank templates) and the records must have been or are currently in use within a six (6) months time period from the inspection date.

Examples:

The SOP listed is FACIL - 001 Pest Control, supporting documentation is required to show that the Pest Control program is in place and is used at the site. If the SOP states that a pest inspection should be conducted every month, the records are required to show that the inspection(s) has been done.

The SOP listed is PERS - 011 Employee Training, instructs to complete job descriptions and ongoing training records for employees at the site. Photocopies of selected job descriptions and training records can be used as supporting documentation.

Note: Any personal employee information may be blacked out.

Deviations and Corrective Actions

For each statement/question, the applicant is required to list any deviations to the Natural Health Products GMPs that were observed during the site inspection.

If the applicant indicates a deviation(s) they must describe in the space provided a description of the deviation(s), and the details of the corrective action(s) that were taken or will be taken.

For each listed deviation(s), a corrective action plan should be attached. Provide any plans, including time lines, for correcting the deviation(s).

The deviation(s) listed could be for minor correction(s) within the site (such as screening and trapping floor drains, or the removal of temporary repairs on equipment) or could be the plans for more major correction(s) (such as the installation of an air filtration system, or the development of SOPs for this section of the Regulations).

Supporting Documentation

List all supporting documentation as described above (SOP record(s), and corrective action plan(s)), and attach the document(s) directly behind the statement/question page.

Attestation

The Quality Assurance Person that completed the Quality Assurance Report needs to PRINT and SIGN his/her name and DATE this part of the QAR form.

Note: This Quality Assurance Person is identified in box # 16a of the QAR form - General Information.

Dosage Forms

(Information to complete QAR form - General Information box # 14)

Note: Applicants are not limited to using dosage forms on this list.

Dosage Form	Definition	Synonyms	Route of Administration
Aerosol	A pressurized pharmaceutical form that contains medicinal agents released upon activation of an appropriate valve system.	Aerosol (without propellant)	Inhalation, topical, nasal
Aerosol, metered dose	A pressurized pharmaceutical form that contains medicinal agents and consists of a metered dose valve that allows for the delivery of a uniform quantity of spray upon each activation.		Inhalation, topical, nasal
Bar, chewable	A solid pharmaceutical form that contains medicinal agents usually in the form of a rectangle. It is meant to be chewed.		Oral
Bulk/loose	Any plant material to be used as a final dosage form.		Oral, buccal, topical, rectal, sublingual, transdermal, vaginal, otic, nasal, ophthalmic
Capsule	A solid pharmaceutical form that contains medicinal agents within either a hard or soft soluble container or shell. The shells are made of gelatin or other substance.		Oral
Capsule, combined release	A capsule that consists of two or more medicinal agents with different delivery characteristics (e.g. immediate release and extended release).	Capsule, dual release	Oral
Capsule, delayed release	A capsule formulated to release the medicinal agents at any time other than promptly after administration.	Enteric coated, repeat action	Oral
Capsule, extended release	A capsule formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.	Sustained release, prolonged release, controlled release, timed release	Oral
Cream	A semi-solid pharmaceutical form that contains medicinal agents dissolved or dispersed in either an oil-in-water emulsion or in another type of water-washable base.		Topical, transdermal
Cream, liposomal	A semi-solid pharmaceutical form that contains medicinal agents and consists of solid particles dispersed in either an oil-in-water emulsion or in another type of water-washable base.		Topical, transdermal
Dentifrice, gel	A gel formulation that contains medicinal agents intended to clean and polish the teeth.	Toothpaste	Dental
Dentifrice, paste	A paste formulation that contains medicinal agents intended to clean and polish the teeth.	Toothpaste	Dental
Douche	A liquid pharmaceutical form containing medicinal agents dissolved in a suitable solvent or mutually miscible solvents that is prepared from powders, liquid solutions or liquid concentrates. It is intended for the irrigative cleansing of the vagina.		Vaginal
Dressing	An external application that contains medicinal agents, resembles an ointment, and is usually used as a covering or protection.		Topical, rectal, vaginal, ophthalmic, otic
Elixir	A clear, pleasantly flavoured and sweetened hydro-alcoholic liquid that contains dissolved medicinal agents. It is intended for oral use.		Oral
Emulsion	A two-phase system that contains medicinal agents, in which one liquid is dispersed through another liquid in the form of small droplets.		Topical
Enema	A solution introduced into the rectum to promote evacuation of feces or as a means of administering medicinal substances.		Rectal
Floss	A thread (waxed or unwaxed) that contains medicinal agents and is used for cleaning between the teeth.		Dental
Fluid extract	An alcoholic or hydro-alcoholic preparation generally providing a dry or fresh herb strength ratio of 1:1 or 1:2.	Liquid extract	Oral
Gel	A semi-solid pharmaceutical form that contains medicinal agents and consists of liquids gelled by means of suitable gelling agents.	Jelly	Topical, oral, vaginal, rectal
Gel, extended release	A gel formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.	Sustained release, prolonged release, controlled release, timed release	Topical, oral, vaginal, rectal
Globules	A small globular mass made of pure sucrose, lactose or other appropriate polysaccharides that are medicated through a drug attenuation process.	Pellets, pillules	For homeopathic products only
Granule	A small particle or grain that contains medicinal agents. They are intended for oral administration. Some are swallowed as such, some are chewed and some are dissolved or dispersed in water or another liquid before being administered.		Oral
Granule, effervescent	A granule in a dry mixture usually composed of sodium bicarbonate, citric acid and tartaric acid that, when in contact with water, has the capability to release gas, resulting in effervescence.		Oral
Granule, delayed release	A granule formulated to release the medicinal agents at any time other than promptly after administration.	Enteric coated	Oral
Gum, chewing	A solid, single-dose preparation that contains medicinal agents, with a base consisting mainly of gum. It is intended to be chewed but not swallowed.		Oral
Jam	A sweet, thick mixture of fruit and sugar that contains medicinal agents.		Oral
Kit	A package that contains a collection of two or more drug products having separate drug identification numbers. or A combination of one or more drug products and non-drug products (e.g. empty, pre-packaged syringes, swabs, tourniquet).		Drug/device combinations and drug/delivery system products are not considered kits
Lotion	A broad term to describe a liquid or semi-liquid preparation that contains medicinal agents, with solid materials suspended in an aqueous vehicle. Lotions are usually a suspension of solids in an aqueous medium, but may also be emulsions or solutions.		Topical, transdermal, vaginal, rectal, otic, ophthalmic
Lozenge	A disc-shaped, solid pharmaceutical form that contains medicinal agents and sometimes flavouring in a hard candy or sugar base. It is intended to be slowly dissolved in the oral cavity, usually for localized effects, although some may be formulated for systemic absorption.	Pastilles, troche	Oral, sublingual
Mouthwash/gargle	An aqueous solution that contains medicinal agents that are swished in the mouth or held in the throat and gargled and subsequently expectorated.		Buccal
Ointment	A semi-solid pharmaceutical form that contains medicinal agents consisting of a single-phase base in which solids or liquids may be dispersed.		Topical, vaginal, rectal, nasal, transdermal
Pad	A cushion-like mass of soft material that contains medicinal agents.	Pledglet	Topical, transdermal
Paste	A semi-solid pharmaceutical form of thick or stiff consistency that contains medicinal agents and large proportions of solids finely dispersed in the base.		Topical, transdermal Not to be used for toothpaste
Patch	A drug delivery system that contains an adhesive backing and that permits the medicinal agents to diffuse from some portion of it (e.g. the backing itself, a reservoir, the adhesive, or some other component) into the body from the site where it is applied.		Transdermal , topical
Patch, extended release	A patch formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.	Sustained release, prolonged release, controlled release, timed release	Transdermal , topical
Pellet	A small, sterile and solid mass consisting of a highly purified medicinal agent (with or without excipients) made by the formation of granules, or by compression and moulding.		For homeopathic products, use globule
Pencil	A solid paste containing medicinal agents, compacted into a tapered cylinder form imitating a common pencil in shape. It is intended for topical application on the skin or skin adnexa.		Topical
Piece, chewable	A solid or semi-solid pharmaceutical form of various shapes (e.g. cube ) that contains medicinal agents and is intended to be chewed and swallowed. It is smaller than a chewable bar, does not qualify as a chewable tablet and is not a gum.	Soft chew, gummy bear, candy	Oral
Plaster	A solid or semi-solid adhesive mass that contains medicinal agents and is spread on a backing material of paper, fabric, moleskin or plastic. Plasters are intended to afford protection and to support and furnish an occlusion and macerating action, and to bring medication into close contact with the skin.		Topical
Powder	An intimate mixture of dry, finely divided medicinal agents intended for internal or external use.		Oral, topical, inhalation, transdermal
Powder, effervescent	An intimate mixture of dry, finely divided medicinal agents in a dry mixture, usually composed of sodium bicarbonate, citric acid and tartaric acid, that when put in contact with water has the capability to release gas, resulting in effervescence.		Oral
Powder, delayed release	An intimate mixture of dry, finely divided medicinal agents formulated to release the medicinal agents at any time other than promptly after administration.		Oral, topical, transdermal
Powder for gel	An intimate mixture of dry, finely divided medicinal agents that upon the addition of suitable vehicles yields a gel.		Topical, oral
Powder for solution	An intimate mixture of dry, finely divided medicinal agents that upon the addition of suitable vehicles yields a solution.	Drops	Oral, topical, sublingual, rectal, vaginal, transdermal, nasal, otic, ophthalmic, irrigation
Powder for suspension, extended release	An intimate mixture of dry, finely divided medicinal agents that upon the addition of a suitable vehicle yields a suspension (a liquid preparation containing solid particles dispersed in the liquid vehicle). It is formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.	Sustained release, prolonged release, controlled release, timed release	Oral, topical
Powder for suspension	An intimate mixture of dry, finely divided medicinal agents that upon the addition of a suitable vehicle yields a suspension (a liquid preparation containing solid particles dispersed in the liquid vehicle).		Oral, topical, sublingual, rectal, vaginal, transdermal, nasal, otic, ophthalmic
Powder, metered dose	A powder containing medicinal agents that is situated inside a container that has a mechanism to deliver a specified quantity.		Oral, inhalation
Shampoo	A liquid soap or detergent that contains medicinal agents and is used to clean the hair and scalp.		Topical
Soap, bar	A solid dosage form in the shape of a bar that contains medicinal agents and is used to cleanse the skin.		Topical
Soap, liquid	A liquid dosage form that contains medicinal agents and is used to cleanse the skin.		Topical
Solution	A liquid preparation that contains one or more chemical substances dissolved (i.e. molecularly dispersed) in a suitable solvent or mixture of mutually miscible solvents.	Drops	Oral, topical, ophthalmic, nasal, rectal, vaginal, transdermal
Solution, extended release	A liquid preparation containing one or more chemical substances dissolved (i.e. molecularly dispersed) in a suitable solvent or mixture of mutually miscible solvents that is formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.	Sustained release, prolonged release, controlled release, timed release	Oral, topical
Sponge	An absorbent pad of folded gauze or cotton that contains medicinal agents.		Topical, vaginal
Spray	An aqueous or oleaginous solution, suspension or emulsion that contains medicinal agents in the form of coarse droplets or as finely divided solids to be applied topically, most usually to the nasal-pharyngeal tract or skin.	Aerosol (without propellant)	Inhalation, nasal, topical
Spray, metered dose	An aqueous or oleaginous solution that contains medicinal agents in the form of coarse droplets or as finely divided solids, and consists of a metered dose valve that allows for the delivery of a uniform quantity of spray upon each spray.		Inhalation, nasal, topical
Stick	A solid pharmaceutical form that contains medicinal agents dissolved or dispersed in a simple or compound excipient that may dissolve or melt at body temperature. It is intended for local application.		Topical
Strip	A long, narrow piece of medicated substance to be applied topically.		Topical
Succus	The expressed juice of a plant, for medicinal use.	Juice	Oral
Suppository	A solid body of varying weight and shape adapted for introduction into the rectal, vaginal or urethral orifice of the human body. It usually melts, softens or dissolves at body temperature.	Ovule	Rectal, vaginal
Suppository, extended release	A solid body of varying weight and shape adapted for introduction into the rectal, vaginal or urethral orifice of the human body that is formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.	Sustained release, prolonged release, controlled release, timed release	Rectal, vaginal
Suspension	A liquid pharmaceutical form that contains medicinal agents and consists of solid particles dispersed through a liquid phase in which the particles are not soluble.		Oral, topical, ophthalmic, otic
Suspension, liposomal	A liquid preparation consisting of an oil phase dispersed throughout an aqueous phase in such a manner that liposomes are formed.		Oral, topical, ophthalmic, otic
Syrup	An oral solution containing high concentrations of sucrose or other sugars.		Oral
Syrup, extended release	An oral solution containing high concentrations of sucrose or other sugars that is formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.	Sustained release, prolonged release, controlled release, timed release	Oral
Tablet	A solid pharmaceutical form that contains medicinal agents and is manufactured by compressing uniform volumes of particles.	Pill, caplet	Oral, sublingual, vaginal
Tablet, chewable	A tablet formulated and manufactured so that it may be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant aftertaste.		Oral
Tablet, combined release	A tablet that consists of two or more medicinal agents with different delivery characteristics (e.g. immediate release and extended release).	Tablet, dual release	Oral
Tablet, delayed release	A tablet formulated to release the medicinal agents at any time other than promptly after administration.	Enteric coated, repeat action	Oral
Tablet, effervescent	An uncoated tablet usually composed of sodium bicarbonate, citric acid and tartaric acid that, when in contact with water, has the capability to release gas, resulting in effervescence.		Oral
Tablet, extended release	A tablet formulated to release the medicinal agents in such a manner to allow a reduction in dosing frequency as compared to that of the medicinal agents presented as a conventional dosage form.	Sustained release, prolonged release, controlled release, timed release	Oral
Tablet, rapid dissolving	A tablet formulated to disintegrate or dissolve in approximately 15 to 30 seconds in the mouth.		Oral
Tea, herbal	Dried herb leaves used to prepare a beverage with therapeutic properties.		Oral
Tincture	An alcoholic or hydro-alcoholic solution prepared from vegetable materials or from chemical substances.		Oral, topical, otic, ophthalmic
Vapour from liquid	A liquid preparation containing medicinal agents converted into a vapour for administration to the lungs for either a local or systemic effect.		Inhalation, nasal
Vapour from solid	A solid preparation containing medicinal agents converted into a vapour for administration to the lungs for either a local or systemic effect.		Inhalation, nasal
Wafer	A thin slice of material that contains medicinal agents.		Topical
Wipe	A cloth that contains a medicinal agents.		Topical