Basic Information

Reference Number

cb-100-85422787

Issuing Organization

National Research Council Canada

Solicitation Type

RFP - Request for Proposal (Formal)

Solicitation Number

23-58116

Title

CTMF EXTERNAL LABORATORY TESTING WFI & PURE STEAM

Source ID

PWGSC

Agreement Types

Canada-Chile Free Trade Agreement (CCFTA)

Canada-Colombia Free Trade Agreement

Canada-European Union Comprehensive Economic and Trade Agreement(CETA)

Canada-Honduras Free Trade Agreement

Canada-Korea Free Trade Agreement

Canada-Panama Free Trade Agreement

Canada-Peru Free Trade Agreement (CPFTA)

Canadian Free Trade Agreement (CFTA)

Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)

North American Free Trade Agreement (NAFTA)

World Trade Organization Agreement on Government Procurement (WTO-AGP)

Canada-Ukraine Free Trade Agreement (CUFTA)

Details

Location

Canada

Dates

Publication

2023/11/07 12:00:00 AM EST

Closing Date

2023/12/04 02:00:00 PM EST

Contact Information

Cindy A Romain

(613) 299-2748

Cindy.romain@nrc-cnrc.gc.ca

Description

he National Research Council of Canada is building a new Clinical Trial Manufacturing Facility (CTMF) that
will house the process and equipment for the production and the quality control of protein, viral vector
or virus-like particle vaccines or biologics.
The products are mainly intended for the Canadian market, regulated by Health Canada under the
authority of the Food and Drugs Act. The facility will require being compliant with Canadian Good
Manufacturing Practices (GMP) as well as FDA current GMP (cGMP) and Eudralex requirements.

The Water for Injection and Pure steam generation and distribution loop must be monitored.
To do so, a certain number of samples needs to be tested in order to meet the regulation expectations,
including the following types;
I. WFI
II. Pure Steam
III. Other (pre-treatment/city water)

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