CTMF EXTERNAL LABORATORY TESTING WFI & PURE STEAM
Solicitation number 23-58116
Publication date
Closing date and time 2023/12/04 14:00 EST
Last amendment date
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)
Contract duration
The estimated contract period will be 12 month(s), with a proposed start date of 2024/01/01.
Trade agreements
-
North American Free Trade Agreement (NAFTA)
-
World Trade Organization Agreement on Government Procurement (WTO GPA)
-
Canada-Chile Free Trade Agreement (CCFTA)
-
Canada-Peru Free Trade Agreement (CPFTA)
-
Canada-Colombia Free Trade Agreement
-
Canada-Panama Free Trade Agreement
-
Canada-Honduras Free Trade Agreement
-
Canada-Korea Free Trade Agreement (CKFTA)
-
Canadian Free Trade Agreement (CFTA)
-
Canada-European Union Comprehensive Economic and Trade Agreement (CETA)
-
Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)
-
Canada-Ukraine Free Trade Agreement (CUFTA)
Reason for limited tendering
A contracting officer can use limited tendering for specific reasons outlined in the applicable trade agreements. The reason for this contract is described below:
-
None
Contact information
Contracting organization
- Organization
-
National Research Council Canada
- Address
-
6100 avenue Royalmount
Montreal, QC, H4P 2R2Canada
- Contracting authority
- Cindy A Romain
- Phone
- (613) 299-2748
- Email
- Cindy.romain@nrc-cnrc.gc.ca
- Address
-
1200 Montreal Rd M58
Ottawa, Ontario, K1J 7L1Canada
Bidding details
Full details regarding this tender opportunity are available in the documents below. Click on the document name to download the file. Contact the contracting officer if you have any questions regarding these documents.
Document title | Amendment no. | Language | Unique downloads | Date added |
---|---|---|---|---|
RFP_2358116_CTMF_External_Laboratory_WFI_Pure_Steam_Medium_complexity_Final_Eng_V2_0.pdf | 001 |
English
|
14 | |
RFP 23-58116_Laboratoire pour le contrôle de l’eau préparations injectables et de l’eau de vapeur pure_FR_.pdf | 001 |
French
|
5 |
Access the Getting started page for details on how to bid, and more.