The Asian Development Bank is financing a consultancy for the Directorate General of Drug Administration, DGDA, to establish a new National Drug Control Laboratory and a training centre in Dhaka, built and equipped to WHO and international standards on a turnkey EPC basis. It runs in three stages, roughly four years in total.
- Stage one is about eight months, preparing the EPC bidding documents, the employer's requirements, the technical specifications and the cost estimates, and supporting DGDA through procurement to contract award.
- Stage two is about twenty-four months, supervising design, construction, equipment installation, commissioning and the start of operations.
- Stage three is about twelve months of defect-liability monitoring, training and closeout.
The responsibilities of the cGLP consultant will be the following for 4 person-months over the project period of 44 months.
1) Assist TL in determining relevant broad design parameters, process designing, flow design, quality standards, section design, specifications, etc. as required for preparation of the bidding document.,
2 )Review the Good Manufacturing Practices (GMP) and GLP submitted by EPC contractor during implementation, commissioning and operation of the VTD facilities and assist DGDA in approval, monitoring and supervision.
3) Assist DGDA in providing expert opinion in scaling up production from pilot to commercial scale, considering technology transfer in alignment with ICH Q5A (Quality of Biotechnological Products).
4) Assist DGDA in providing expert opinion on international regulatory requirements, including WHO TRS, FDA 21 CFR Part 211.
5) Assist DGDA in determining the production capacities for the identified product portfolio.
6) Assist DGDA in setting up quality standards.
7) Assist DGDA in finalization of layout, specifications for international standard testing lab and training center.
8) Any other task as per requirement. |