HEALTH CANADA SITE/
ESTABLISHMENT LICENSING

In response to the HC planned inspections to assess how Canadian companies follow the NHP GMPs parameters, our company (QMRS) led by Dr. J. Mokhalalati, is inviting you to call us if you need any support to pass the HC NHP inspection. Namely, we, with almost 30 years of experience in regulatory and scientific affairs in Canada and overseas are very equipped and ready to extinguish the inspection fire, stress and risks.

Our Company (QMRS) expertise includes

  • Provides pre inspection support for NHPs
  • Conduct audit and may issue a “Certificate of GMPs Compliance”.
  • Providing many types of training certificates.
  • Prepare a site license application & the “Quality Assurance Report” for NHPs.
  • Assist foreign companies to obtain the “Foreign Site Reference Number
  • Helping clients to become a licensed Marihuana producer.

In this page, you will read:

NATURAL HEALTH PRODUCTS SITE LICENSE REGULATIONS

A site licence is required for the physical site in Canada. To apply for a site license, applicant must submit to HC a site license application, a Quality Assurance Report (QAR) and evidence of GMP Compliance.

Quality Assurance Report (QAR): Is an attestation by the applicant that the site meets all the requirements of the GMP. The report, in brief, is based on the GMP requirements that set out in HC GMPs guidelines.

EVIDENCE OF GMP
This may be demonstrated by one or more of the following “Pre-Cleared Evidence”:
1. Drug Establishment Licence (DEL): Applicant may submit a copy of their current DEL demonstrating compliance with the requirements of the Food and Drug Regulations. By submitting a DEL, the site licence applicant is attesting to comply with the same standards for NHPs as for drugs.
2. Foreign Site Reference Number (FSRN) Authorization: The NNHPD may issue a FSRN to a foreign site that has demonstrated compliance to GMP Regulations via a separate FSRN application process. Once issued a FSRN, foreign site owners may authorize Canadian importers to reference their FSRN as an alternative to providing GMP evidence for their site.
3. Good Manufacturing Practices Certificate from a Qualified Authority (QA): QA is an authority member from a country, where HC has a Mutual Recognition Agreement (MRA) regarding GMP for drug products, or an authority member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

LIST OF MUTUAL RECOGNITION AGREEMENT (MRA) AUTHORITIES

Australia, Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, United Kingdom. Click to review the list of PIC/S members.

Click to review the list of PIC/S members.

NOTE: The NSF International Standard for Dietary Supplements Certificate has been found to partially cover the requirements of HC GMP Regulations and may be submitted in support of a site licence application along with other additional supporting information, which may include: the finished product testing and stability information.

ALTERNATE GMP STANDARDS (AND/OR ACCREDITATION BODIES)
The NNHPD promotes on-site verification of compliance as it may provide a greater level of assurance that products sold in Canada meet appropriate standard of quality.
Therefore, applicants may submit other audits or inspection reports along with their QAR to assist in demonstrating compliance with the GMP Regulations.
Qualifications of the auditor or the person responsible of the inspection, parameters (standard) adopted for the audit, and corrective actions are also required. To review the auditor profile, please
visit this LINK.

QMRS PRE-INSPECTION SUPPORT

In response to the HC planned inspections to assess how Canadian companies follow the NHP GMPs parameters, our company (QMRS) led by Dr. J. Mokhalalati, is inviting you to call us if you need any support to pass the HC NHP inspection. Namely, we, with almost 30 years of experience in regulatory and scientific affairs in Canada and overseas are very equipped and ready to extinguish the inspection fire, stress and risks. Read More
So, if you’ve already been notified for an inspection, (or if you are on the HC screen for one issue or another) and need urgent support, we will jump to help. I such case, our office in Ottawa, Ontario will
work as an extension of your office.

GOOD DOCUMENTATION PRACTICES:
QMRS is a leader in Canada in the field of “Good Documentation Practices” for the Food and Drug regulations. Our documents address the drug, NHP, Clinical trials, Medical Devices and Food Safety
(HACCP) requirements. All QMRS procedures, templates and training courses are written according to HC guidelines).
QMRS team can assess your documentation system adequacy against HC Natural Health Product Good Manufacturing Practices regulations. We can correct the deficiencies (filling the gaps by modifying your SOP or adding new SOPs). The good thing is that we know Health Canada requirements.
If you select to invite us for an On-Site pre inspection audit, we can conduct a “mock inspection” and behave as HC inspectors to assess your readiness to secure the Compliance (C) rating. Certainly, this practice (having an external auditor) is the best way for companies to identify deficiencies or issues.
Then, based on the number and type of deficiencies, QMRS task will be developing a Corrective and Preventive Action (CAPA) plan.
The method to develop the CAPA plan is detailed below. Our source is: Health Products Compliance Directorate, NHP Bulletin 6, (2024).

QMRS AUDIT APPROACH WHAT IS AUDIT?

The International Standard Organization (ISO) defines audit, as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectivity to determine the extent to which audit criteria are fulfilled (ISO 9000: 2000).
Also, the International Conference on Harmonization (Good Clinical Practice: Consolidated Guideline) defined audit as “A systematic, and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practices (GCP), and the applicable regulatory requirements”.

In brief, quality audits examine products, processes, and systems with respect to predetermined standards.
Within this context, quality audits evaluate one or more of the following

  • .  The adequacy of the documentation system.
  • . Compliance to the documented procedures, implementation, and maintenance of the procedures.
  • . And the effectiveness of the procedures to accomplish intended objectives.

1. TYPES OF AUDITS
Quality audits could be classified into:
First Party Audit (Internal Audit): it is performed within the organization by its own employees. The objective of first party audit is to assure maintenance, development, and improvement of the quality system in order to fulfill the applicable regulations.
Second Party Audit: This is an external type of audits, which is conducted on client behalf to ensure, for example that the delivered materials were produced, and managed according to the established requirements, and to secure that contracted parties (packager, labeller, and distributor) are handling your products appropriately.
Third Party Audit: Is an audit by an independent body to determine that the auditee’s organization Quality Management System is fulfilling specific standard or regulations.

2. QMRS AUDIT APPROACH
a) AUDIT PREPARATION
PHASE ONE AUDIT (OFF-SITE AUDIT): The objective of this audit is to determine your company state of readiness for stage two audit (on-site audit). Phase one audit could be implemented by conducting a review of your documentation system. information on your company performance history will be reviewed to ensure that positive practices are continued and problems were corrected.
At this stage, if QMRS finds that the quality of documentation is inadequate, an audit checklist will be sent to you for further evaluation. The checklists are a pre-structured questionnaire extracted from HC GMP Guidance Document. On the other hand, if the documentation review shows that your organization conforms to the regulations, the auditing process in such case can proceed to the on-site phase, where a site audit will be arranged.
PHASE TWO AUDIT PLAN (ON-SITE AUDIT): Upon client request to proceed with the auditing process, QMRS will prepare the audit plan. The plan will contain topics such as, audit objectives, scope, date, logistical arrangement, confidentiality, and the needed resources.
b) AUDIT PROCESS:

Our strategy is to adopt the element method, which is based on four categories (places, people, processes, and products). We will examine each element individually to see how it affects the system.
c) REVIEW & CLOSING MEETINGS
When the audit is complete, audit findings will be classified into:

  • . Observational, which are the points that deserve some comments, whether good points or sometimes situation of concern but not serious enough to be considered non-conformity.
  • . Failure to conform to the GMP regulations usually leads to issuing the Corrective Action
    Request (CAR).

THE AUDIT PROCESS

GATHERING INFORMATION

(Documents, interviews and observations)

VERIFY THE INFORMATION

(Confirm by examining its validity)

COMPARE WITH THE APPLICABLE REGULATIONS

(Health Canada GMPs requirements)

REPORT THE FINDINGS

d) CORRECTIVE ACTION REQUEST (CAR)
This is a form, where we will write the non-conformity statements. The corrective action request will be issued for all observations; Risk one, two, and Risk three observations.
e) AUDIT FINAL REPORT

A precise written report will be prepared and submitted to you upon audit completion. The report will be complete and comprehensive. It will include recommendations for improvement, and a follow-up plan.
f) AUDIT COMPLETION
All records of the audit processes will be returned to client as per contractual requirements. Confidentiality will be always maintained (look at PRIVACY  & LIABILITY). The audit will be considered completed (ended) upon submission of the audit report.

THE CORRECTIVE AND PREVENTIVE ACTION (CAPA) PROCESS

There are eight key steps in the CAPA process:
STEP 1. DOCUMENT AND RECORD THE ISSUE:
You must establish a form to document the issue as part of the quality system. Use the Form (###)
which is attached to the SOP “Corrective and Preventive Action”), SOP Number (###).
STEP 2. PUT TOGETHER A TEAM TO INVESTIGATE:
For medium and large size companies, you need to assemble a team made up of the appropriate personnel. For a small companies, the QA with the General Manager should assess the level of risk and determine the level of intervention. For example, the observation that one of the site windows are not well fixed and needs a minimal repair, does not need an investigation because the issue is obvious, but if the levels of microbes in the finished products exceed the allowed limits, such problem need a thorough investigation to determine the source of contamination.
STEP 3. CONTAIN AND CORRECT THE ISSUE:
This may involve putting a specific process on hold or quarantining the product, while the issue is being investigated. For example, high-risk issues such as the finished product lab testing results are not in line with the finished product specifications require immediate correction to mitigate risks and hold the product (no release to the market).
STEP 4. IDENTIFY THE CAUSE:
This is to determine the actions that must be taken to ensure the issue doesn't happen again. Use an appropriate methodology such as the Fishbone diagram or the Five Whys root cause analysis tool to
help identify the cause.
STEP 5. ASSESS THE IMPACT:
To ensure the entire issue has been analyzed, identify what went wrong, the likelihood of the issue happening again and the severity of the consequences. Use categories to describe the level of impact
(critical, major or minor, or high, medium or low) and outline these in your documentation. Consider if similar issues could apply to other products.
STEP 6. TAKE APPROPRIATE ACTION WITHIN A TIME FRAME:
The level of action you take should be in proportion to the risk and complexity of the issue.

For example, if an issue could impact a product, your CAPA plan may include changes to the manufacturing process or a recall of impacted lots distributed. In the CAPA plan, you will need to record the timeline for implementing corrective and preventive actions, considering the resources (time, personnel, materials) used.
STEP 7. MONITOR THE PLAN’S EFFECTIVENESS:
By answering these questions: (a) Did the immediate corrections actions taken address the underlying issues and their root causes? (b) Did the corrections and actions taken result in any negative consequences and, if so, how will these be addressed?
If the CAPA plan was not effective, you may need to go through steps 1 to 7 again to determine what went wrong and make any necessary changes.
STEP 8. CLOSE THE PLAN:
Before you close the CAPA plan, site GM should ensure the issue is fully corrected and prevented. And should the records and documents for each step of the process are kept and maintained.
Records should include a description of the immediate corrections taken, the results of the root cause and impact analyses, a description and the date that CAPAs were implemented, the effectiveness of the actions taken, the date the plan was closed.

HEALTH CANADA CAPA PLAN ASSESSMENT

Worth noting is that the CAPA plan is mandatory, as it’s an important part of the inspection and licensing process. HC review the CAPA plan to ensure it mitigates the risk posed by the observations they made.
It is required that the company must provide the plan by the due date and have clear target dates for completing it.
As one might expect, HC may ask for documented evidence to demonstrate and support the actions taken.
Obviously, your company needs to Invest time and effort to prepare and implement the CAPA plan. Needles to confirm that QMRS is prepared to meet your due date and would be happy to contribute to your success. we assure you that we can make the inspection process smooth and manageable.

Alternatively, QMRS offers a self-audit checklist. This self Inspection tool is easy-to-use. It helps you determine if your company is fulfilling HC GMP requirements.
The checklist will allow you to identify all the Risk (1) observations which may lead to noncompliant rating. To purchase the document, please email us at:
jalal@qmrs.com.

In brief, whether you are a manufacturer or an importer, QMRS can assist you to fulfill your regulatory needed.

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