We have a very good record with reference to helping small and medium-size facilities to obtain Health Canada site license.

HEALTH CANADA SITE / ESTABLISHMENT LICENSING

FHPD prepares the Site License Application Form and the “Quality Assurance Report” that needed by HC to receive the site license.

FHPD offers clients complete turnkey solutions including:

We provide all the needed GMP SOPs
We provide blank templates (records) as per Health Canada requirements.
We provide many types of training certificates including Natural Health Products GMP certificate, Dietary Supplements GMP certificate (USA New Rules), Drug GMP, and Good Documentation Practices (GDP) certificates.

FHPD conducts a “Third Party Audit” to assess the degree to which the facility is fulfilling the applicable GMPs requirements.

FHPD awards the facility a “Certificate of GMPs Compliance” if the site found to be fulfilling the FDA or Health Canada GMPs requirements (Including the Dietary Supplements New Rules)

GMP AUDIT AND CERTIFICATION

BACKGROUND
The International Standard Organization (ISO) defines audit, as a “systematic, independent, and documented process for obtaining audit evidence and evaluating its 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 an 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 with the documented procedures, implementation, and maintenance of the procedures.
And the effectiveness of the procedures to accomplish intended objectives.

TYPES OF AUDIT

Quality audits could be classified into:

First Party Audit (Internal Audit)
This is performed within the organization by its own employees. The objective of a 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 audit, which is conducted on the client's 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-PartyAudit
Is an audit by an independent body to determine that the auditee’s organization Quality Management System is fulfilling specific standard or regulations.

FHPD AUDIT APPROACH

A. AUDIT PREPARATION

1) PHASE ONE AUDIT: Phase one audit is also called pre-audit or off-site audit. The objective of this phase is to determine the organization's state of readiness for stage two audit (or the actual auditing), which will be conducted on-site. Phase one audit could be implemented by conducting a review of your organization's policies, guidelines, and procedures. Furthermore, information on the organization's performance history will be reviewed to ensure that positive practices are continued and problems were corrected. The review results will be sent to you to let you know your level of compliance with the applicable regulatory requirements (whether US FDA or Health Canada).
At this stage, if FHPD finds that the quality of documentation is inadequate (a possibility), an audit checklist will be sent to you for further evaluation. The checklists are a pre-structured questionnaire extracted from the applicable regulatory agency Good Manufacturing Practices 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.

2) PHASE TWO / AUDIT PLAN: Upon your request to proceed with the auditing process, FHPD will prepare the audit plan. The plan will contain topics such as audit objectives, scope, date, logistical arrangement, confidentiality, and the needed resources. Your confirmation on these matters will lead to the on-site audit activities .

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. The audit process takes place according to the following steps:

C. REVIEW & CLOSING MEETINGS
When the audit is complete, audit findings will be classified into:

1) 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.
2) Failure to conform to the reference standard usually leads to issuing the Corrective Action Request (CAR). A draft report (preliminary audit results) will be presented at the end of the meeting.

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 as necessary).

E. AUDIT FINAL REPORT
A precisely 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 retained in accordance with the applicable statutory, regulatory, and contractual requirements. Confidentiality will be maintained at all times. The audit will be considered completed (ended) upon submission of the audit report.

G. FOLLOW-UP/SECOND VISIT
Upon your request, FHPD can follow-up activities in respect of corrective action requested. Also, you might wish to send us periodic reports in order to be able to verify the facility's compliance status. FHPD experts would be very pleased to assist you in any manner you choose.

CANADIAN IMPORTERS
FROM USA
The only evidence, which is accepted by HC is a GMPs inspection report from the United States Food and Drug Administration (US FDA) as a Qualified Authority. If the applicant has such a document (the most recent inspection report, including the corrective actions taken, the need is limited to submitting a licence amendment to add the new foreign site without completing the Quality Assurance Report (QAR) for this foreign site. But, it is required to complete/submit the QAR for the new foreign site, if the GMP evidence is not from US FDA.

MUTUAL RECOGNITION AGREEMENT (MRA)
The Health Products and Food Branch Inspectorate presently have Mutual Recognition Agreement (MRA) related to GMPs with the following countries:
Switzerland,
Australia,
the European Community (Austria; Belgium; Czech Republic; Denmark; Finland; France; Germany; Greece; Hungary; Ireland; Italy; Netherlands; Portugal; Spain; Sweden; and the United Kingdom).
In addition to the European Free Trade Association (EFTA) countries which include: Iceland; Liechtenstein; and Norway.

Please note the following:

A. MRA countries can submit alternate GMP evidence in one of two forms:

1) A Certificate of Compliance (CoC) issued by a Regulatory Authority for a Site/Recognized Building for which the date of inspection indicated is no more than three years old. or
2) The most recent inspection report (including corrective actions taken) that is no more than three years old issued by a Regulatory Authority for a site located outside its jurisdiction as long as the inspection has been conducted based on its GMP standard or the Canadian GMP guidelines.

B. Non-MRA countries can submit alternate GMP evidence in one of three forms:

1)The most recent inspection report (including corrective actions taken) that is no more than three years old issued by a Regulatory Authority for a site located outside its jurisdiction as long as the inspection has been conducted based on its GMP standard or the Canadian GMP guidelines.
2) The most recent inspection report (including the corrective actions were taken) from a Qualified Authority for a site located within or outside its jurisdiction.
3) A Good Manufacturing Practices Certificate issued by a Qualified Authority for a Site/Recognized Building located in its jurisdiction for which the date of inspection indicated is no more than three years old.

Also, please note that:
Qualified Authority means agencies such as the United States Food and Drug Administration (US FDA) or an authorized member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) which includes the following member countries:
Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Malaysia, Netherlands, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, Spain, Sweden, Switzerland, United Kingdom.

FHPD EXPERTISE
FHPD is qualified to assess the degree to which the facility is fulfilling the applicable GMPs requirements.

1) FHPD will award you (and your foreign site) a “Certificate of Good Manufacturing Practices Compliance” if the facility found to be fulfilling the current GMPs requirements.

2) For your facility (whether you are manufacturer or importer), we prepare (complete) the Site License Application Form and the “Quality Assurance Report” that needed by Health Canada to receive the site license.

3) For small and medium-sized companies, we assist clients to establish the needed SOPs and policies pertaining to GMPs that needed by regulatory authorities.

4) FHPD designed a number of training courses to fulfill the GMP's requirements. Our courses are very specific as our target trainees are the personnel working in health products sectors

5) We issue six types of certificates that needed by regulatory authorities. Trainees who participated in any of these programs will receive a “Certificate of Completion” from QMRS.

We have many documents (Audit checklist, SOPs, policies, and templates), which cover almost all aspects of GMPs and GCPs matters as required by the pharmaceutical industry.

These documents were written in accordance with the current GMP parameters. Our sources are the US FDA, Health Canada, the International Conference on Harmonization (ICH) and the general principles of GMP as set out in the WHO guidelines Good Manufacturing Practices for Pharmaceutical products (WHO Technical Report Series, No. 908). 

To view these documents' titles and purposes, Email Us.

In brief, whether you are a manufacturer, packager, labeller, or importer, FHPD can assist you to fulfill your local regulatory authority's GMPs requirements. Just send us an email at [email protected] for more details.

WHAT'S NEW

USP RELEASES SUPPLEMENTS COMPENDIUM FOR GMP COMPLIANCE

The United States Pharmacopeia (USP) has released its Dietary Supplements Compendium (DSC).

USP said its compendium provides lists of quality specifications (identity, strength, purity and performance characteristics) for more than 500 dietary supplements and ingredients. Surely, the DSC will significantly assist manufacturers to comply with current Good Manufacturing Practices (GMPs).