Professional Services for Quality assurance (QA) consultant clinical trial material facility (CTMF)
Solicitation number 23-58170
Publication date
Closing date and time 2024/01/15 14:00 EST
Last amendment date
Description
2. BACKGROUND
The NRC is building a new permanent, GMP-compliant clinical trial material facility (CTMF) at its Royalmount Avenue site in Montréal. When complete, this facility will be used to manufacture vaccine and other biologic materials for clinical trials, to support vaccine development at the clinical trial stage.
As a member of the multidisciplinary project teams, the consultants specialized in Quality Assurance, actively participates in all stages of the implementation, validation and operationalization of the CTMF in compliance with applicable Health Canada, European and FDA regulations, internal policies and procedures.
3. OBJECTIVE(S)
The consultants will provide quality assurance support during the implementation, validation and operationalization of the CTMF
4. DESCRIPTION AND STATEMENT OF WORK, DELIVERABLES AND TIMELINES
Review and approve documents generated for the following processes:
1. Equipment and facility validation
2. Product tech transfer
3. GMP processes for facility operationalization and start-up such as:
3.1. Access Management
3.2. Alarm Management
3.3. Analytical Method validation
3.4. Batch Record
3.5. Batch release
3.6. Buffer/media prep
3.7. Clean Utilities
3.8. Material Cleaning (manual and part washer)
3.9. DSP (Downstream processes)
3.10. Filtration Validation
3.11. Incoming material release
3.12. Pest control
3.13. Preventive Maintenance / Calibration Program
3.14. QMS (Deviation, change control, CAPA)
3.15. Room classification (gowning/material/EM)
3.16. Room Cleaning & Sanitation
3.17. Sampling
3.18. Sterilization Validation
3.19. Supplier Management
3.20. Training
3.21. USP (upstream processes)
3.22. Warehouse
Contract duration
The estimated contract period will be 5 month(s), with a proposed start date of 2024/01/29.
Trade agreements
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Canada-Chile Free Trade Agreement (CCFTA)
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Canada-Peru Free Trade Agreement (CPFTA)
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Canada-Colombia Free Trade Agreement
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Canada-Panama Free Trade Agreement
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Canada-Honduras Free Trade Agreement
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Canada-Korea Free Trade Agreement (CKFTA)
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Canadian Free Trade Agreement (CFTA)
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_23-58170_PROFESSIONAL SERVICE QA CONSULTANT_CTMFV3_incAnnex_SR_19Dec.pdf | 001 |
English
|
31 | |
RFP 23-58170_Services professionnels_AQ_pour l’installation de production de matériel pour essais cliniques (IPMEC)final_0.pdf | 001 |
French
|
15 |
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