Supplementary Quality Assurance Report Form Homeopathic Medicines (HM)

General Information

A. Submission

1. Type

• Site Licence Application
• Amendment
• Renewal

2a. Date of last inspection or SQAR completion

2b. Type of inspection:

B. Building Information

3. Building Name

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

5. Dwelling House
Yes
No

6. Address, Number/Street/Suite/Land Location

7. City-Town

8. Province/State

9. Postal Code/Zip Code

10. Country
CANADA

C. Operation(s) at this Building

11.

Add		Non-Sterile HM Dosage Form(s)	Sterile HM Dosage Form(s)
	Manufacturing
	Packaging
	Labelling

D. Quality Assurance Person(s) (QAP)

12a. 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:

12b.

• In-House
• Third Party

13a. Print the Name of Quality Assurance Person 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 met:

13b.

• 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 Supplementary Quality Asssurance Report

Premises [Section 45]

1. Building is designed to accommodate storage and processing of homeopathic medicine:

1. isolating and handling toxic and/or biological materials in separate areas away from other materials; and Yes No
2. successive attenuation are performed in a laminar airflow workstation. Yes No

If yes, describe for (a) and (b) 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 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]

2. Authorized personnel working in areas designed for attenuation and trituration have the appropriate training and attire. Yes No

If yes, describe how individual(s) meet the requirements to perform their duties relating to the activities, types of natural health products and dosage forms.
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).
• Other supporting documents maybe job descriptions, roles and responsibilities of key personnel.
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Processes

Sanitation Program [Section 48]

3. A sanitation program has been established to include:

1. cleaning requirements for raw material storage areas; Yes No
2. cleaning, microbial and environmental monitoring requirements for all processing areas; and Yes No
3. cleaning production equipment using heat methods (e.g. autoclave). Yes No

If yes, for (a), (b) and (c) 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 for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Operations [Section 49]

4. Procedures are in place for handling raw material(s) that are potentially toxic. 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 for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

5. Critical production processes are controlled (such as labelling equipment, containers and raw materials used during in-process stages). 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 for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

6. Control systems for critical production processes are in place (e.g. measures to ensure adequacy of heat processing of the first attenuation in the preparation of nosodes). 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 for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

7. The master formula includes special precautions that may be relevant to the particular classification of preparation (e.g. nosodes). 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 for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Product

Specifications [Section 44]

8. All homeopathic products are prepared in accordance with specifications that include the methods outlined in one of the homeopathic pharmacopoeias *.

* Such as the Homeopathic Pharmacopeia of the United States (HPUS) or German Homeopathic Pharmacopoeia (GHP).

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 for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

Stability [Section 52]

9. Procedures are in place to ensure that the expiry date of an attenuation does not exceed that of the raw material(s) from which it is prepared. 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 for more details).
• Attach supporting documentation such as action plans with timelines for each corrective action identified above.

List of attachments:

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, air filtration, water quality and system maintenance records…
2	Personnel Training		47		Certificates of data logs (with trainee signature) of on-going GMP training (specific to homeopathic manufacturing, internal or external)
3	Premise, Equipment and Utensils Cleaning		48		Data logs of site/facility Cleaning (production and non production area) and equipment cleaning (specific to homeopathic manufacturing, including schedules and frequencies)
4	Raw Material Handling and Control		49, 51(2)		SOPs, certificates of analysis, material release forms, batch records, master production documents, out of specifications investigation reports…
5-7	Process Control		49		Batch records, master production documents, out of specifications investigation reports
8	Specifications		44, 51(4)		Specification sheet including the reference to the homeopathic pharmacopoeia, certificate of Analysis, batch records of finished products and raw materials, if applicable.
9	Stability		52		Data logs from accelerated or real-time stability studies (must show product meets its label claim at time of expiry), raw material stability data.

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