SERVICES

 

HEALTH CANADA SITE / ESTABLISHMENT LICENSING

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

• QMRS 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.

• QMRS conduct “Third Party Audit” to assess the degree to which the facility is fulfilling the applicable GMPs requirements.

• QMRS 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)

In fact, we already have a very good record with reference to helping small and medium size facilities to obtain Health Canada site license

 

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 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.

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 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.

 

QMRS 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 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 policies, guidelines, and procedures. Furthermore, information on the organization 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 QMRS 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. Please, click on ON-LINE PURCHASE section for additional information (The section explains the benefits of on-line support, and how to purchase the audit checklist). On the other hand, if the documentations 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, QMRS 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:

 

 

GATHERING INFORMATION
(Documents, interviews and observations)

 

VERIFY THE INFORMATION
(Confirm by examining its validity)

 

COMPARE WITH THE APPLICABLE REGULATIONS
(US FDA and Health Canada GMPs requirements)

 

REPORT THE FINDINGS

 

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 some times 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 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 retained in accordance with the applicable statutory, regulatory, and contractual requirements. Confidentiality will be maintained at all times (PRIVACY & LIABILITY). The audit will be considered completed (ended) upon submission of the audit report.
 

G. FOLLOW-UP/SECOND VISIT

Upon your request, QMRS 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 compliance status. QMRS experts would be very pleased to assist you in any manner you choose.

 

Reviewers of this page are advised to review the principal’s article “Natural Health Products Site License: An Analysis of “Risk 1 Observations”, which was published in “The Newsmagazine of the Canadian Association of Professional Regulatory Affairs”. Author Dr. Jalal Mokhalalati. Issue No. 62, Pages 9-14; fall 2004). A free copy of this article will be sent to you upon request.

 

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 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 United Kingdom).

In addition to the European Free Trade Association (EFTA) countries which include: Iceland; Liechtenstein; and Norway .

 

Please note the following:

1. 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.

    

2. 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 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 authority 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, Leichtenstein , Malaysia, Netherlands, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, Spain, Sweden, Switzerland, United Kingdom.

QMRS EXPERTISE

• QMRS is qualified to assess the degree to which the facility is fulfilling the applicable GMPs requirements.

• QMRS 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

• 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.

• For small and medium size companies, we assist clients to establish the needed SOPs and policies pertaining to GMPs that needed by regulatory authorities.

• QMRS designed a number of training courses to fulfill the GMPs requirements. Our courses are very specific as our target trainees are the personnel working in health products sectors

• We issue six types of certificates that needed by regulatory authorities. Trainee who participated in any of these programs will receive a “Certificate of Completion” from QMRS (Please click Certificate  to view a sample of QMRS certificates).

We have many documents (Audit checklist, SOPs, policies, and templates), which cover almost all aspects of GMPs and GCPs matters as required by 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, please click on ON-LINE PURCHASE

 

In brief, whether you are a manufacturer, packager, labeller, or importer, QMRS can assist you to fulfill your local regulatory authority GMPs requirements. Just send us an email at info@qmrs.com 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).