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 (GMP) of the Natural Health Products Regulations (the Regulations).

Applicants must complete one report for each building/site and provide it to the Natural and Non-prescription Health Products Directorate (NNHPD) along with the site licence or foreign site reference number application.

The report must be completed by a person that has the necessary qualifications to assess the operations of the facility.

General Information

A. Company/Building Information

1. Company/Building Name. State the registered name of the company/building as it appears on the site licence or foreign site reference number application form.

2-6. Address (Number/Street/Suite/Direction). State the physical address where the building is located in boxes 2 to 6. Note that P.O. Boxes are not accepted as a building address.

B. Operation(s) at this Building

7. a) Indicate the applicable activity/activities that will be performed. Acceptable activities are: manufacturing, packaging, labelling, and/or importing or storage only. Note that manufacturing, packaging, labelling, and/or importing include storage.

Indicate if the natural health product(s), and/or homeopathic medicine(s) is/are: non-sterile or sterile.

For definitions related to activities and dosage forms, please consult the Good Manufacturing Practices guidance document.

7. b) Contract manufacturer. Indicate a firm (business) that manufactures, packages, and/or labels a natural health product, or performs any other activity or operation in respect of a natural health product, under the terms of an agreement with another party. Additional terms of reference may include: contract manufacturing organization or contractor.

7. c) Secondary packager (labeller). Indicate a firm (or business) that puts a natural health product, which is already packaged in its immediate container, into a secondary container. The secondary package is not in direct contact with the natural health product. For the purpose of site licensing, the secondary packager is considered a labeller.

7. d) Supplementary QAR form (for homeopathic medicines). When manufacturing, packaging, and/or labelling homeopathic medicines, the supplementary QAR (sQAR) form must be completed and attached, in addition to the QAR. Indicate that the sQAR has been attached, if applicable.

8. Dosage Form(s). The final physical form of the natural health product that may be used by the consumer without requiring any further processing is the dosage form. Indicate the dosage form(s) handled at the site. A list of acceptable dosage forms can be found in the Natural Health Product Ingredients Database. Refer to the Natural Health Product Ingredients Database Web Application Guide for more information.

9. Product Type(s). Indicate the natural health product type(s) handled at this site.

C. Quality Assurance Person(s) (QAP)

10. a) Name of Quality Assurance Person. Print the name of the QAP who completed the QAR for this building as per section 28(f) of the Regulations. Please note that the individual listed in this box must be the same individual who signs the attestation located on the second page of the QAR. If there is a discrepancy, your QAR will not be considered acceptable evidence of Good Manufacturing Practices (GMP) compliance for the site in question.

10. b) Identify the type of QAP indicated in box 10. a) by checking one of the following:

• In-house (within an organization, by employees, rather than by a third party)
• Third-Party (independent of the company s/he is auditing).

Note: The QAP must be qualified by training, experience and technical knowledge.

11. a) Name of Quality Assurance Person. The name of the QAP who is responsible for ensuring compliance to Section 51 of the Regulations (approving the materials, methods and procedures; approving product release for sale and resale; and investigating and recording complaints) is met.

Note: the person identified in box 11. a) may be the same person as identified in box 10a.

11. b) Identify the type of QAP indicated in box 11. a) by checking one of the following:

• In-house (within an organization, by employees rather than by a third party)
• Third-Party (independent of the company s/he is auditing).

Attestation

The QAP who completed the QAR must print his/her name, as well as sign and date this section. This QAP must be the same person identified in box 10. a) of the QAR form. If there is a discrepancy, the QAR will not be considered as acceptable evidence of GMP compliance. The QAR is valid for a period of one (1) year from the date of the attestation. If an outdated QAR is received by the NNHPD, it will not be considered as acceptable evidence of GMP compliance.

Detailed Quality Assurance Report

Part 3 (sections 43 to 62) of the Regulations sets out the GMP that manufacturers, packagers, labellers, and importers must meet before a site licence can be issued. For each question of the QAR, the following information must be provided. Failure to address any of the sections listed below without acceptable rationale may result in a refusal.

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, and sterile products).

Check the response to the statement/question as either ‘Yes’ that statement/question is correct, or ‘No’ that statement/question is not correct. Refer to the appropriate section(s) in the Good Manufacturing Practices guidance document for assistance.

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. Simply stating that a question is not applicable without adequate rationale is considered to be a non-response.

Supporting Documentation

List or provide all supporting documentation, as requested for each statement/question in the QAR form. The supporting documentation requested may consist of a list of standard operating procedures (SOP) applicable to the section, copies of the actual SOP, and/or supporting records.

A SOP is an authorized written procedure giving instructions for performing operations, and is not necessarily specific to a given product or material but may be of a more general nature. A SOP can be defined as an established method 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 SOP may be used to supplement product-specific master production documents. More information on SOP can be found in the Good Manufacturing Practices guidance document.

A list of SOP (titles and numbers) is required for all questions indicated in the QAR. The complete SOP must be provided for questions 6 (quality assurance product release), 9 (recall), 10 (finished product specifications and testing), 11 (determination of expiry date), and 14 (product sterilization).

In addition, for certain statements/questions, the applicant is required to provide supporting records to demonstrate that the SOP listed and/or provided are being followed on a regular basis. Complete records are required to support questions 6. (quality assurance product release), 10. (finished product specifications and testing), and 11. (determination of expiry date).

If the activity/activities has/have not commenced, SOP, along with templates, are acceptable. Once the activity/activities has/have commenced and/or upon the site licence/foreign site reference number renewal application, completed records from within the last 12 months will be required. All documents must be provided in one of Canada's official languages. Alternatively, a translated version maybe provided along with the original document.

List of Products Manufactured, Packaged, Labelled, Imported, and/or Stored at the Site

Applicants are required to list natural health products that are manufactured, packaged, labelled, imported, and/or stored at the site.

In situations where the site being evaluated is a foreign contract manufacturer, only products that will be imported into the domestic site to which the site licence pertains will need to be listed.

Provide a complete list of all the natural health products that are manufactured, packaged, labelled, imported, and/or stored at the site. For each product, indicate the: product name, dosage form, product type, route of administration, natural product number (NPN), and storage conditions requirements.