Instructions for Completing the Supplementary Quality Assurance Report Form for Homeopathic Medicines

When dealing with homeopathic medicines, applicants must complete the Quality Assurance Report (QAR) Form and the Supplementary Quality Assurance Report (SQAR) Form for Homeopathic Medicines. These reports are used for self-assessment of the operations against the requirements of Part 3, Good Manufacturing Practices (GMP), of the Natural Health Products Regulations (the Regulations) and the GMP outlined in the Natural Health Products guidance document.

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 standard QAR and 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 building addresses.

B. Operation(s) at this Building

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

Indicate if applicable homeopathic medicine dosage forms 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.

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. Method of Preparation Reference. Indicate the appropriate pharmacopeial methods of reference from the list provided.

C. Quality Assurance Person(s) (QAP)

10. a) Name of Quality Assurance Person. Print the name of the QAP who completed the SQAR 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 SQAR. If there is a discrepancy, your SQAR will not be considered acceptable evidence of 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).

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

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 SQAR 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 SQAR will not be considered as acceptable evidence of GMP compliance.

The SQAR is valid for a period of one (1) year from the date of the attestation. If an outdated SQAR is received by the NNHPD, it will not be considered as acceptable evidence of GMP compliance.

Detailed Supplementary 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 or foreign site reference number can be issued. For each question of the SQAR, 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 person), 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 ‘Yes’ is answered and a description is required, outline as appropriate. 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 SQAR 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 standard operating procedures 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 SQAR.

In addition, for certain statements/questions, the applicant is required to provide supporting SOP or records to demonstrate that the SOP listed and/or provided are being followed on a regular basis.

If activities have not commenced, SOP along with templates are acceptable. Once the activity has commenced and/or upon the site licence or 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.