Quality Assurance Report (QAR) Form

General Information

A. Submission

1. Type

• Site Licence Application
• Amendment
• Renewal

2a. Date of last inspection or QAR completion

2b. Type of inspection:

B. Building Information

3. Building Name

4. Building Number (if more than 1 QAR submitted) of (one QAR per building)

5. Dwelling House

6. Office

7. Address (Number/Street/Suite/Land Location)

8. City-Town

9. Province/State

10. Postal Code/Zip Code

11. Country
CANADA

C. Operation(s) at this Building

12a.

Add		Non-Sterile Dosage Form	Sterile Dosage Form	Homeopathic Medicine
	Manufacturing
	Packaging
	Labelling
	Importing* (Reduced testing program: Y / N)
	Storage only

12b. Supplementary QAR form (for homeopathic medicines only) attached?
Yes
No
*Not required for importing activities

13. Dosage Form(s):
(Please consult: Instructions for Completing the Quality Assurance Report Form)

• Capsule
• Tablet
• Pellet
• Liquid
• Lotion
• Extract
• Tincture
• Powder
• Other (specify)

14. Product Type(s):

• Plant, alga or fungus
• Extracts
• Vitamins
• Essential fatty acids
• Homeopathic medicines
• Non-human animal material
• Isolates
• Minerals
• Synthetic duplicates
• Traditional medicines
• Bacterium
• Enzymes
• Amino acids
• Probiotics

D. Quality Assurance Person(s) (QAP)

15a. Print the Name of Quality Assurance Person (in Section 28 (f)) who completed the QAR for the building listed in box #3 of this form:

15b.

• In-House
• Third Party

16a. Print the Name of Quality Assurance Person who is responsible for ensuring that 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 met:

16b.

• In-House
• Third Party

Attestation

I attest that the building(s), practice(s), and procedure(s) used for conducting activities in our facility comply with the good manufacturing practices set out in Part 3 of the Natural Health Products Regulations.

Name of Quality Assurance Person (Please print)

Signature of QA Person

Date yyyy-mm-dd

Detailed quality assurance report

Places

Premises [Section 45]

(1) Building is designed to prevent cross-contamination and mix-up of the natural health product(s) by way of:

1. appropriate space to carry out the operations of the facility; Yes No
2. separated production and non-production areas; and Yes No
3. sealed building surfaces (e.g., windows, floors, ceilings and production surfaces) made of materials that facilitate maintenance and sanitation. Yes No

If yes, describe for (a), (b) and (c) how the premise's design complies with NHP GMPs. If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

(2) Building is designed to prevent cross-contamination and adulteration of the natural health product(s) by way of:

1. adequate ventilation, filtration and airflow; Yes No
2. appropriate plumbing; and Yes No
3. appropriate water supply for the intended purposes (e.g., production, cleaning or utility functions). yes No

If yes, describe for (a), (b) and (c) how the premise's design complies with NHP GMPs. If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

(3) Raw material(s) and finished product(s) are stored under conditions that maintain quality and safety (such as temperature, humidity and light controls). Yes No

If yes, describe the conditions and how they are controlled and monitored. If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

(4) Building is designed and maintained to prevent the entry and harbouring of insects, rodents, birds and other animals. Yes No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Equipment [Section 46]

(5) Equipment is

1. designed, constructed and maintained to prevent contamination of the natural health product(s). Yes No
2. functioning in accordance with its intended use through routine maintenance and calibration. Yes No

If yes, describe for (a) and (b) how the equipment complies with NHP GMPs.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

People

Personnel [Section 47]

(6) In meeting the company's requirements, individuals in charge of manufacturing, packaging, labelling and/or storage activities have appropriate education, training or experience, including appropriate initial and ongoing good manufacturing practices (GMP) training necessary to perform their assigned duties. Yes No

If yes, describe how individual(s) meet the requirements to perform their duties relating to the activities, types of natural health product(s) and dosage form(s).
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Quality Assurance [Section 51]

(7) In meeting the company's requirements, the Quality Assurance Person(s) has the appropriate training, experience and technical knowledge. Yes No

If yes, describe how the Quality Assurance person(s) meet the requirements, and has the qualifications to perform their duties relating to the activities, types of natural health product(s) and dosage form(s).
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• A Quality Assurance Person Qualification Form is required to be completed.
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Quality Assurance [Section 51]

(8) Does this site have a Quality Assurance Person(s) responsible for:

1. approving the raw, packaging and labelling materials; Yes No
2. methods and procedures; Yes No
3. approving product release for sale and resale; and Yes No
4. investigating and recording complaints Yes No

If yes, describe for (a), (b), (c) and (d) how the quality assurance person complies with NHP GMPs.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Provide a copy of the SOPs for (1) quality assurance release and (2) complaint handling.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Processes

Sanitation Program [Section 48]

(9)

1. A sanitation program has been established at the site (whole site/ facility). Yes No
2. Written procedures are established and followed for effectively cleaning the premises. Yes No
3. Written procedures are established and followed for the cleaning of the equipment and utensils. Yes No

If yes, describe the cleaning procedures including schedules and frequencies.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Page 11 of 25 Sanitation Program [Section 48]

(10) An employee health and hygiene program has been established at the site to protect the natural health product(s) against adulteration and contamination. Yes No

If yes, describe
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Operations [Section 49]

(11) Material control procedures are in place from the receipt to the release of raw, inprocess, packaging, labelling, and reprocessed material(s). Yes No

If yes, describe how materials (raw, in-process, packaging and labeling) are quarantined, approved, returned and designated for disposal.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Operations [Section 49]

(12) Critical process controls are in place, where applicable, at the site for:

1. manufacturing activities; Yes No
2. packaging activities; Yes No
3. labelling activities; Yes No
4. importing and storage activities. Yes No

If yes, describe for (a), (b), (c) and (d) where applicable, the critical process controls.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

(13) A self inspection program against Part 3 of the Natural Health Products Regulations has been established at the site. Yes No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

(14) An inspection program has been established for any work contracted out, (e.g., contract testing laboratories, domestic suppliers, foreign suppliers, etc.) have been established. Yes No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Operations [Sections 50 and 62]

(15)

1. Written procedures are in place at the site to ensure the effective recall of a product. Yes No
2. Written procedures are in place to ensure that the required information is submitted to Health Canada (Health Products and Food Branch Inspectorate (HPFBI) Regional Operational Centre) when a recall is initiated. Yes No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• If a product recall has not been done at the site, attach a blank template of the product recall form.
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

Attach a recall template/ record

List of attachments:

Product

Specifications [Section 44]

(16)

1. Written procedures are in place and followed to assess finished natural health products against written specifications. Yes No
2. Written procedures are in place to ensure that any change(s) in specifications are reflected in the operations and that every change is approved by the quality assurance person. Yes No
   
   (Note: any changes to product specifications require a product licence notification and/or amendment)

If yes, describe and provide evidence for at least two product types manufactured, packaged, labelled and stored on site.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions for more details).
• Provide certificates of analysis
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

(17) Written procedures are in place and followed to assess raw and/or packaging materials against written specifications. Yes No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Provide records of raw material testing if a part of the finished product specifications
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Stability [Section 52]

(18)

1. Data from accelerated or real-time stability studies or from similar product formulations are used in the initial determination of the expiration date. Yes No
2. An on-going stability program is in place at the site. Yes No

If yes, describe how expiry dates are determined and demonstrate that manufactured and/ or imported products meet their specifications at expiry.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Samples [Section 61]

(19) A sample retention program is in place at the site. Yes No

If yes, describe (including information on the duration of retention, environmental conditions, final trade packages, destruction of samples etc.)
If no, provide a rationale and a copy of a completed Alternate Sample Retention form

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Records [Sections 53 to 57]

(20) Required records are maintained as per the Natural Health Products Regulations. Yes No

If yes, for all activities conducted at the site, identify in the boxes below where each of the following records are kept. Use 'O' for records maintained on-site and use 'A' if you have access to the records but they are kept off site.
If no, provide a rationale.

Record	Manufacturer	Packager	Labeller	Importer
Master production document
Manufacturing order
Packaging order
Labelling order
Test results: raw material
Test results: packaging material
Test results: finished product
Specifications: raw material
Specifications: packaging material
Specifications: finished product
Stability summary
Ingredients list
Products list
Distribution list
Complaints
Sanitation program
Other(please specify)

If additional space is required, please attach on a separate sheet.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Records [Sections 58]

(21) Batch and lot records for the natural health product(s) are maintained as per the Natural Health Products Regulations. Yes No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Sterile (e.g. Ophthalmic) Products [Sections 59 and 60]

(22) *All sterile (ophthalmic) products are manufactured and packaged:

1. in a separate and enclosed area; Yes No
2. under the supervision of personnel trained in microbiology; and Yes No
3. using a method scientifically proven to ensure sterility. Yes No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established. Yes No

List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail the corrective action(s) taken and/or to be taken.

Supporting documentation

• Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above (see instructions and records check list for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

*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 posted on Health Canada website.

List of products manufactured (m), packaged (p), labelled (l), imported (i) and stored (s) at the site

Product Name (Please attach the specifications)	Other Brand Names	Dosage form	Product Type	NPN	PLA #	Storage conditions requirements	Shelf Life	M-P-L-I-S

Records check list (Please provide samples that have been in use within the last six months)

Questions of the QAR	Record Type	Check Box	Relevant sections of the NHPR	*Quality Technical Agreement	Example of Acceptable Record Types
1	Building Design		45		Floor plan
2	Building Design		45		Air filtration, water quality and system maintenance records...
3	Storage Controls		45		Data logs recording temperature, humidity, and light controls
4	Pest Control		45		Contractor pest control invoice, internal pest activity inspection logs
5	Equipment Design, Maintenance and Calibration		46		Maintenance and calibration records (include schedules and frequencies)
6	Personnel Training		47		Certificates of data logs (with trainee signature) of on-going GMP training (internal or external)
7	QAP Qualifications		51(1)(a)		QAPQF, training records, certificates, job description, resume, roles and responsibilities
8	Quality Assurance		51(1)(b),(3),(4)		Product release forms, complaint records, and adverse reaction reporting records, if any
9	Premise, Equipment and Utensils Cleaning		48		Data logs of site/facility Cleaning (production and non production area) and equipment cleaning (include schedules and frequencies)
10	Employee Health and Hygiene		48		Hygiene policies, instructions
11	Material Control		49		Certificates of analysis, material release forms, batch records, master production documents, out of specifications investigation reports...
12	Process Control		49		Batch records, master production documents, out of specifications investigation reports
13	Self Inspection		49		Check list or report
14	Inspection of Contractors		49		Check list or report
15	Recall		50, 62		Product recall records
16	Finished Product Testing		44, 51(4)		Certificate of Analysis, batch records of finished products and raw materials, if applicable.
17	Raw & Packaging material approval/ release		44, 51(2)		Certificates of analysis, batch records, material release forms
18	Stability		52		Data logs from accelerated or real-time stability studies (must show product meets its label claim at time of expiry)
19	Sample Retention		61		Sample retention record or alternate sample retention form
22	Sterile ophthalmic NHPs		59, 60		Evidence of supervisor training in microbiology, clean room/ laminar flow hood maintenance records, product sterilization records, batch records

*Please provide copies of signed and dated quality technical agreements along with the relevant record samples as evidence.