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QUALITY ASSURANCE REPORT (QAR) FORMNatural Health Products Directorate Protected when completed

HC USE ONLY Date/Time of Receipt

Submission Number

File Number

Please refer to the instructions on how to complete this 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. CountryCANADA

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: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/form/forms_qar_instructions_e.html)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 IsolatesMinerals 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-HouseThird Party

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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: (a) appropriate space to carry out the operations of the facility; (b) separated production and non-production areas; and(c) sealed building surfaces (e.g., windows, floors, ceilings and production surfaces) made of materials that facilitate maintenance and sanitation.

Yes Yes Yes

No No 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 ProceduresRelevant standard operating procedures are established.List all standard operating procedures (SOPs) (titles and numbers) for this section.

Yes No

Deviations and corrective actionsIdentify 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

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► 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:

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(2) Building is designed to prevent cross-contamination and adulteration of the natural health product(s) by way of:(a) adequate ventilation, filtration and airflow; (b) appropriate plumbing; and (c) appropriate water supply for the intended purposes (e.g., production, cleaning or utility functions).

Yes Yes Yes

No No No

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


Yes No


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.


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(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.


Yes No


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.


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(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.


Yes No




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Equipment [Section 46]

(5) Equipment is (a) designed, constructed and maintained to prevent contamination of the natural health product(s). (b) functioning in accordance with its intended use through routine maintenance and calibration.

Yes

Yes

No

No

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


Yes No




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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.


Yes No




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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.


Yes No


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.


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Quality Assurance [Section 51]

(8) Does this site have a Quality Assurance Person(s) responsible for: (a) approving the raw, packaging and labelling materials; (b) methods and procedures;(c) approving product release for sale and resale; and (d) investigating and recording complaints

Yes Yes Yes Yes

No No No 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 ProceduresRelevant standard operating procedures are established.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.

Yes No




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PROCESSES

Sanitation Program [Section 48]

(9) (a) A sanitation program has been established at the site (whole site/ facility).(b) Written procedures are established and followed for effectively cleaning the premises.(c) Written procedures are established and followed for the cleaning of the equipment and utensils.

Yes Yes

Yes

No No

No

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


Yes No




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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, describeIf no, provide a rationale.


Yes No




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Operations [Section 49]

(11) Material control procedures are in place from the receipt to the release of raw, in-process, 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.


Yes No




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(12) Critical process controls are in place, where applicable, at the site for: (a) manufacturing activities;(b) packaging activities;(c) labelling activities; (d) importing and storage activities.

Yes Yes Yes Yes

No No No No

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


Yes No




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(13) A self inspection program against Part 3 of the Natural Health Products Regulations has been established at the site.

Yes No



Yes No




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(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



Yes No


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:

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Operations [Sections 50 and 62]

(15) (a) Written procedures are in place at the site to ensure the effective recall of a product.

(b) 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

Yes

No

No



Yes No


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/ recordList of attachments:

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PRODUCT

Specifications [Section 44]

(16) (a) Written procedures are in place and followed to assess finished natural health products against written specifications.

(b) 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.(Note: any changes to product specifications require a product licence notification and/or amendment)

Yes

Yes

No

No

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


Yes No


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.


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Specifications [Section 44]

(17) Written procedures are in place and followed to assess raw and/or packaging materials against written specifications.

Yes No



Yes No


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.


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Stability [Section 52]

(18) (a) Data from accelerated or real-time stability studies or from similar product formulations are used in the initial determination of the expiration date.

(b) An on-going stability program is in place at the site.

Yes

Yes

No

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.


Yes No




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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 (http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodnatur/sample_echantillons-eng.pdf)


Yes No




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

Yes No


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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



Yes No


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

(22) *All sterile (ophthalmic) products are manufactured and packaged: (a) in a separate and enclosed area; (b) under the supervision of personnel trained in microbiology; and (c) using a method scientifically proven to ensure sterility.

Yes No



Yes No


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*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.

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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

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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/facilityCleaning (production and non production area) and equipment cleaning (includeschedules 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 ofexpiry)

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.

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Documents

inhouse formcheckbox

office formcheckbox

party formcheckbox attestation

dwelling house formcheckbox

building information

supplementary qar form

quality assurance persons

qar completion2b