QMRS Services
SITE LICENSE SUPPORT (GMP Audit)
Background
The International Standard Organization defines the term 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). More specifically, 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 practice (GCP), and the applicable regulatory requirement(s)”.
What does Audit measure?
Quoting from “The Quality Audit Handbook” (ASQ, 2000), Quality audits examine products, processes, and systems with respect to predetermined standards. Within this context, quality audits evaluate one or more of the following:
ü The adequacy of the documentations.
ü Compliance to the documented procedures, implementation, and maintenance of the procedures.
ü And the effectiveness of the procedures to accomplish intended objectives.
Types of Audit
Quality audits could be classified into:
A. 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.
B. Second Party Audit
This is an external type of audits which is conducted on your behalf to ensure that the delivered materials were produced, and managed according to your requirements, and to secure that your packager, labeller, and distributor are handling your product appropriately.How can QMRS help?
We can assist you with:
ü Raw materials suppliers
We can conduct inspection on your behalf to ensure that your suppliers of raw materials fulfill Health Canada specifications.ü Packagers and labelers
As per part two, section 27 of Health Canada NHP Regulations, no one shall manufacture, package, label or import a natural health product for sale unless the person holds a site license and the person conducts the activity in accordance with the requirements set out in part 3.ü Contract manufacturers
QMRS audit checklist will assure you that your contract manufacturer is in full compliance with NHPD requirements.ü Importers
Health Canada requires Canadian importers to provide evidence that imported products are coming from sites that meet Canada GMP requirements (Otherwise, Canada custom could refuse the entry of these products).Therefore, importers need to submit a Quality Assurance Report signed by a third party auditor, who has the technical experience and training in this type of activities. Australia, Switzerland, Sweden, France and United Kingdom are excluded due to the Memorandum of Understanding (MOU).
QMRS is qualified to audit the foreign site on your behalf, and is prepared to complete, and sign the Quality Assurance Report (please visit My Credentials to assess my qualifications for third party auditor. In brief, whether you are a manufacturer, packager, labeller, or importer, QMRS can assist you to fulfill Health Canada requirements. Just send us an email at info@qmrs.com for more details.
Is an audit by an independent body, to determine that the auditee’s organization quality management system is fulfilling specific standard or regulations? In this context, following is QMRS auditing methodology.
1. AUDIT PREPARATION
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 continue and problems were corrected.
The review results will be sent to you to let you know your level of compliance with the Health Canada regulatory requirements. The documents review report will cover:
The review objective
The review criteria
The review scope
The findings and conclusions
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 checklist is a pre-structured questionnaire extracted from the Natural Health Products Good Manufacturing Practices Guidance Document and designed to be for on-line service. Please, click on ON-LINE PURCHASE section for additional information (The section will explain our methodology, 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 Health Canada 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: 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
2. AUDIT PROCESS:
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
(Health Canada: NHPD requirements)
Report the findings
Our strategy is to adopt the element method, which is based on the NHPD four categories (places, people, processes, and products). We will examine each element individually to see how it affects the system.
3. 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 some times situation of concern but not serious enough to be considered non-conformity.
Failure to conform with the reference standard, which leads to issuing the Corrective Action Request (CAR).
A draft report (preliminary audit results) will be presented at the end of the meeting.
4. 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).
Needless to mention that a compliance rating will be assigned in all situations in which only Risk (3) observations are observed (Health Canada; NHPD: GMP Guidance Document)
Reviewers of this page are advised to review the principal’s article, which, published in “the Newsmagazine of the Canadian Association of Professional Regulatory Affairs” (www.capra.ca).
Title: Natural Health Products Site License: An Analysis of “Risk 1” Observations.
Author, Dr. Jalal Mokhalalati
(NOC; Issue Number 62, Pages 9-14; fall 2004).
Please click on WHAT'S NEW for more information.
5. 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.
The report will cover the following key elements:
· Audit objectives and scope
· Number of identified non-conformities
· A copy of all CARs will be attached
· Audit conclusions
· Report on all significant findings on each process
· The written report will be sent to you within five working days from the date of the closing meeting, or agreed time period.
6. 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 to client.
7. 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.
Payment
QMRS AUDIT RATES (CANADIAN $)
1. GMP audit checklist 240.00
2. Review the completed checklist (basic). 050.00
3. Issue Corrective Action Requests ( per CAR)* 025.00
4. On-Site audit**
One day/One person 1500.00
One day/Two persons 2500.00
Two days/One person 2500.00
Two days/Two persons 3500.00
*CARs will be issued for Risk (1) and Risk (2) observations only, to ensure that the charges will not exceed CAD 500.00. CARs will be issued for Risk (3) observations if the total number of Risk (1) and Risk (2) observations are less than 20 observations (this is to make the maximum charge $500.00 or less.
**Rates depends on facility size.
The total off-site audit cost (including the audit checklist) will not exceed CAD 1000.00
PAYMENT RULES
1. All prices are quoted in Canadian dollars.
2. Canadian clients need to add 7% to the total for the Goods and Services Taxes (GST). (Our GST No. is: 85555 2147 RT0001)
3. Half of the fees will be invoiced 30 days prior to the actual visit (Confirmed on-site visit date)
4. Change or cancelation to confirmed audit date will be subject to additional fees;
If change notice received between 15 to 30 days of audit confirmed date, the additional fee will be 10%.
25% will be added, if the change happened before 15 days of audit confirmed date.
5. Associated travel expenses such as, hotels, local transportation, and meals will be billed upon completion, except air ticket, which will be purchased in advance by the client.
6. For overseas travel (Out of North America), the minimum billing will be four days (Considering two days for traveling).
7. Also, other travel expenses such as, country entry Visa, or airport fees will be invoiced separately (for regions outside North America such as, Asia, and Australia).
8. The second half of the fees to be paid upon submission of the audit final report.
9. Additional charges will be made for any additional work requested by the client (for follow-up activities in respect of CAR).
10. Free assessment could be requested if the client purchased the GMP audit checklist
Subject to subsection (2) no person shall manufacture, package, label or import a natural health product for sale unless:
(a) Holds a site license issued in respect of the activity, and
(b) The person conducts the activity in accordance with the requirements set out in part 3.
Source: Canada Gazette (June 18, 2003), Natural Health Products Regulations, Part 2: Site Licenses, 27(1).
