Posted Date : July 07,2020
Product (RFP/RFQ/RFI/Solicitation/Tender/Bid Etc.) ID : UNCT-17588
Government Authority located in Kingston, Rhode Island; USA based organization looking for expert vendor for compliance and validation services.
[A] Budget: Looking for Proposals
[B] Scope of Service:
(1) Vendor needs to provide compliance and validation services to current good manufacturing practices and phase-appropriate quality management systems for the pharmaceutical development institute to the government authority located in Kingston, RI.
- Quality system audits observing personnel in the manufacturing areas and laboratories to assure they are following relevant procedures and working in compliance
- Facility audits to assure the facilities, equipment and systems are fit for purpose and relevant documentation to support processes are in place
- Review and approval of standard operating procedures, manufacturing and analytical methodology, protocols and reports for the qualification and validation of processes, facilities, equipment and systems
- Review and approval of changes or deviations that occur in the manufacture, packaging and testing of investigational products
- Review and release of batches of investigational products to ensure that they have been manufactured, packaged and testing in accordance with and are suitable for use in clinical trials
(2) All question must be submitted no later than July 14, 2020.
[C] Eligibility:
- Onshore (USA Only);
[D] Work Performance:
Performance of the work will be Offsite. Vendor needs to carry work in their office location.
Budget :
Deadline to Submit Proposals: July 30,2020
Cost to Download This RFP/RFQ/RFI/Solicitation/Tender/Bid Document : 5 US$
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Product (RFP/RFQ/RFI/Solicitation/Tender/Bid Etc.) ID : UNCT-17588
Government Authority located in Kingston, Rhode Island; USA based organization looking for expert vendor for compliance and validation services.
[A] Budget: Looking for Proposals
[B] Scope of Service:
(1) Vendor needs to provide compliance and validation services to current good manufacturing practices and phase-appropriate quality management systems for the pharmaceutical development institute to the government authority located in Kingston, RI.
- Quality system audits observing personnel in the manufacturing areas and laboratories to assure they are following relevant procedures and working in compliance
- Facility audits to assure the facilities, equipment and systems are fit for purpose and relevant documentation to support processes are in place
- Review and approval of standard operating procedures, manufacturing and analytical methodology, protocols and reports for the qualification and validation of processes, facilities, equipment and systems
- Review and approval of changes or deviations that occur in the manufacture, packaging and testing of investigational products
- Review and release of batches of investigational products to ensure that they have been manufactured, packaged and testing in accordance with and are suitable for use in clinical trials
(2) All question must be submitted no later than July 14, 2020.
[C] Eligibility:
- Onshore (USA Only);
[D] Work Performance:
Performance of the work will be Offsite. Vendor needs to carry work in their office location.
Budget :
Deadline to Submit Proposals: July 30,2020
Cost to Download This RFP/RFQ/RFI/Solicitation/Tender/Bid Document : 5 US$