QMRS Services
ONLINE PURCHASE
This is our on-line store to provide you with the needed assistance regardless of your location: Whether you are located in Canada, or overseas.
OR type of activity:
Whether you are a manufacturer, packager, importer, or distributor).
The following pages contain information on QMRS off-site audit's methodology, and a list of documents (SOPs, and audit checklists), which you can purchase on line. The purchasing procedure, and the off-site audit approach, process, and benefits are all detailed below:
Under section 2 (1,b) of the Natural Health Product regulations, the site license requirements apply to the importers of Natural Health Products as it applies to the local manufactures, packagers, and labelers.
Therefore, an audit of foreign manufacturing sites is required in order to complete the Quality Assurance Report, which is required by Health Canada.
QMRS encourages importers of natural health products to adopt our methodology of conducting off-site assessment prior to the actual on-site visit (Please click on SITE LICENSE SUPPORT for more information).
Clearly, off-site audit checklist is not prepared only for foreign manufacturers. It is in fact, an ideal internal audit tool for any natural health products manufacturing plant, distribution centre, packaging, and labeling facilities applying for site license.
What you’ll benefit?
The benefits of adopting off-site assessment could be summarized as follow:
1. You (the manufacturer, packager, labeler or importer) can conduct the assessment at your convenient.
2. Fast to conduct, no logistical arrangements are needed.
3. Allow you to monitor your foreign organization compliance continuously.
4. Help to spread the message among the employees that quality is essential and continuous improvement is necessary.
5. Checklist will be used as a valid document to prove that "internal audit program is in place".
QMRS APPROACH
Our approach is based on a pre-structured Checklist (24 pages). The checklist covers all of the current Good Manufacturing Practices (GMPs) elements, as indicated in Health Canada NHPD Guideline (please refer to SITE LICENSE SUPPORT under audit preparation section) for more details, and/or click on WHAT'S NEW to learn about the principal article " Natural Health Products Site License: An Analysis of "Risk 1" Observations.
The purchasing method could be summarized as follow:
Order the GMPs audit checklist on-line, by email, mail, or fax.
Complete the checklist by one of your employees who is knowledgeable about the manufacturing processes (not required to be a quality assurance person).
Return the completed checklist by email, fax, or mail to QMRS for examination.
QMRS will identify all non-conformity observations (our parameter is Health Canada: NHPD Guidance Document on GMPs).
A Corrective Action Request (CAR) will be issued (within five working days of receiving the completed checklist) for all Risk (1) and Risk (2) non- conformity observations.
QMRS will forward to you (by email) the completed CARs for your action.
QMRS is prepared to follow- up the needed improvement and to arrange for the on-site visit.
You might request the principal signature as a third party auditor/ quality assurance person to complete the process.
CONSIDERATIONS:
Internal auditor should be selected on the basis of knowledge and experience of the area to be audited (but not the Quality Assurance Person him/herself).
Auditor (assessor) should focus on systems, and processes rather than housekeeping matters.
Record of such self-inspection, and any subsequent corrective action should be maintained.
You might choose to purchase the checklist only. Namely, your employees (by themselves) will examine your readiness for inspection (against the checklist elements).
But if you decided to make an advantage of our expertise a confidentiality agreement will be signed between your organization and QMRS upon your request (please visit Privacy & Liability to review the Confidential Disclosure Agreement)
And the following rates will apply:
GMP Audit Checklist $200.00
Review the completed Checklist (basic). $100.00
Issue Corrective Action Requests (per CAR) $025.00
Please note that:
CARs will be issued for Risk (1) and Risk (2) observations only.
Risk(3) observations, will be listed under "other observations" to draw your attention only. But no CARs will be issued unless otherwise will be requested.
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).
These rates limited to Good Manufacturing Practices only. Clinical research (GCPs) audit parameters, and rates are different from GMPs. Please contact us for details on GCPs rates.
II. STANDARD OPERATING PROCEDURES
In addition to the audit checklists, QMRS prepared many procedures on regulatory affairs, as well as clinical research matters, which are available also, on-line.
These documents are prepared according to Health Canada: NHPD Regulations and guidelines.
The procedures are written to save your employees time.
They need very little modifications to be specific to your organization.
QMRS objective is to make sure you meet Health Canada documentation requirements.
To make you more confident about our products, you will find under DOCUMENTATION SUPPORT a copy of one of these procedures.
This is to confirm that, these documents (the audit checklists, and the SOPs) were written to assist you (the purchaser) to prepare your facility for successful regulators audit. Therefore, QMRS accepts no liability for any subsequent regulatory observations, or actions arising from the use of these documents. (Please click on PRIVACY AND LIABILITY for more details)
III. PAYMENT OPTIONS
1. Pay with Credit Card via PayPal
This service is provided by PayPal, which provides a secure environment for the processing of on-line credit card transaction by using the most advanced privacy protection technology available.
What is PayPal?
PayPal makes sending money as easy as sending email. Members can instantly and securely send money to anyone with an email address. PayPal is available to people in 45 countries (to view the countries click the link).
Is PayPal secure?
Yes. PayPal uses SSL technology to keep your information safe. In addition, when you send a payment using PayPal, the recipient (QMRS) won't receive sensitive financial information like your credit card, or bank account number.
How Easy Is the Process?
The process is very simple, just follow the following steps:
Click ‘add to cart’ for the document you choose.
When all chosen documents completed, click on view cart.
After you review all of the cart contents, click checkout.
Now, PayPal will take you to their payment details page.
You will be asked to enter your credit card information and email address.
After completion the needed information, you will be taken to a confirmation page containing the details of your payment, where you need to click ‘Pay’ to complete the payment.
When the process completed successfully, you will receive an email receipt for the transaction confirming payment, and a copy of the payment details.
PayPal will send QMRS an email notification of your payment.
Upon your payment reflected in QMRS account balance, the document will be transmitted to you electronically (via email).
Please note that you will be able to make credit card payment without signing up for a PayPal account.
B. Paying by Check
We accept certified or draft checks in Canadian, or USA dollars. Make check payable to ‘Quality Medical Regulations Services’, addressed to 196 Annapolis Circle, Ottawa, Ontario K1V 1Z1 Canada.
You have the option to fax us your check to prepare your order; you can then mail it to us. But, please note that we only process orders when check has been received and verified by the bank.
C. Paying by Bank Transfer
Payment could be sent to TD Canada Trust Bank, or Royal Bank of Canada. Account number, and address will be provided to you upon your request. Please make sure that your bank’s wire fee is included In the amount transferred. As above, we only process orders when payment has been received, and verified by the bank.
Please note that Canadian clients should add a 7% to the total for the Goods and Services Taxes (Our GST No. is: 85555 2147 RT0001)
IV. DELIVERY OPTIONS
Please note the following:
The indicated prices are based on delivering the document via email. Extra charges will be added if you choose to receive the document as a hard copy, CD ROM or diskettes.
All packages are shipped via UPS unless otherwise requested.
Shipping charges for Canada, USA and overseas will be calculated according to current UPS Canada Rate Guide.
For diskettes or CDs orders, please add Canadian $30.00 (handling costs are included).
Most orders are shipped within two business days from receipt of the payment.
Business days are from Monday to Friday (Saturday and Sunday excluded). Therefore, when estimated delivery time will be calculated, business days only counted.
V. AVAILABLE DOCUMENTS FOR TRANSACTION
Document Purpose: This checklist is one part of a complete checklist to assess the capability, and adequacy of the Clinical Research Organization (CRO)
Document Code: ACK-03
Please note that this document is part of document No. (ACK-02)
$CAD 70.00
Document Purpose: This checklist is one part of a complete checklist to assess the capability and adequacy of the Clinical Research Organization (CRO)
Document Code: ACK-04
Please note that this document is part of document No. (ACK-02)
$CAD 36.00
Document Purpose: This checklist is one part of a complete checklist to assess the capability, and adequacy of the Clinical Research Organization (CRO)
Document Code: ACK-05
Please note that this document is part of document No. (ACK-02)
$CAD 95.00
Good Clinical Practices SOPs
Document Purpose: To describe the regulatory authorities requirements for conducting clinical investigations, involving human subjects.
Document Code: SSP-001
$CAD Free
Document Purpose: To provide the basic principles for conducting clinical investigations, involving human subjects.
Document Code: SSP-002
$CAD 36.00
Document Purpose: The purpose of this SOP is to provide guidance on conducting post-marketing surveillance studies (PMS) for Natural Health products.
Document Code: SSP-003
$CAD 36.00
Document Purpose: This is to specify the procedure for transferring the responsibilities, pertaining to clinical trials activities from the corporate to a second party (a contract research organization).
Document Code: SSP-004
$CAD 38.00
Document Purpose: To describe the documentation required from the principle investigator prior to release of clinical product to start the clinical phase of the trial.
Document Code: SSP-005
$CAD 24.00
Document Purpose: To describe the process for selecting the investigator(s) to conduct clinical trials involving human subjects.
Document Code: SSP-006
$CAD 14.00
Document Purpose: To define the corporate responsibilities as a sponsor for conducting clinical trials under ICH: GCP Guideline.
Document Code: SSP-007
$CAD
96.00
Document Purpose: To define the responsibilities of the investigator, who is involved in clinical research involving human subjects.
Document Code: SSP-008
$CAD 84.00