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) of the Natural Health Products Regulations and 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 SQAR 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.

13a Refers to Section 28 (f) of the Natural Health Products Regulations. The name of the Quality Assurance Person (QAP) who completed the SQAR for the building listed in box #3 of this form.

13b The QAP identified in box #13a 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 #13a is the individual who is required to sign the Attestation of the SQAR.

14a 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 # 14a could be the same person as identified box # 13a.

14b The QAP identified in box #14a 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 - 022 Attenuation and Trituration Training for Employees 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, maybe blacked out.

Deviations and Corrective Actions

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

If the applicant indicates a deviation(s) they must describe in the space provide 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 the timelines, 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 Supplementary 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 # 13a of the QAR form - General Information.