Current Job and Project Opportunities
Posting: #FDAAA 17-018
Job/Opportunity: GMP inspection
Organization: Sidra Hospital in Qatar
Sidra Hospital in Qatar is seeking help in preparing for GMP inspection. If I am reading the tea leaves correctly, this looks like an opportunity that could influence how the entire country approaches GMPs! Here is what they have outlined:
We are seeking a consultancy service from a member of the FDA Alumni Association (FDAAA) with previous experience in Good Manufacturing Practice (GMP) inspection. The aim is to use the expertise of an FDAAA member to guide us through our effort to develop our manufacturing facilities, to comply with the US GMP standards, and therefore be ready for GMP inspection.
What is Sidra?
Sidra Medical and Research Center is an ultramodern women and children hospital based in Doha, Qatar. It was established a few years ago with the objective of conducting cutting edge research in specific medical fields and providing high quality health services for women and children. The long term objective is to be ranked among the most advanced research hospitals in the region with state-of-the-art medical equipment and sophisticated laboratories to nurture innovation and clinical advancement.
For more information about Sidra, you may visit this link: http://www.sidra.org.
What are the Clinical Research Center (CRC) activities?
The CRC is a part of the Research Branch of Sidra. The mission of the CRC is to develop therapies for therapeutic purposes and for clinical trials. The establishment of the CRC is still in the early stages. The facilities within the CRC are being acquired and laboratories are being setup with 2 laboratories equipped with portable GMP modules (Biospherix, USA). Currently, SOPs are being written.
The facility aims to develop cell- and tissue-based clinical trials and cell and gene therapies using good manufacturing production facilities. Therefore, it needs to be purpose-designed and inspected by a medicinal regulatory agency to absolutely ensure the safety of these cellular products.
This is the first GMP facility in Qatar. The objective is to deliver cellular products for diverse clinical settings, including cancer, diabetes, autoimmune diseases, and hemophilia among others.
What is the Role of the Qatari Ministry of Public Health (MoPH)?
The Qatari MoPH acts as the National Regulatory Agency, implying that they are responsible for certifying the GMP manufacturing facilities and our processes are in compliance with GMP standards. However, given that the MoPH is itself a new institution and that our GMP facility is the first in the country, the MoPH has no expertise in performing GMP inspection, nor do they have GMP standards and guidelines.
GMP Inspection for Compliance
After consulting with the MoPH, we were advised to have the GMP inspection performed by a foreign international recognized regulatory agency. Once this is done, the MoPH will be willing to recognize this attestation of compliance, and consequently, they will grant us a national certificate of GMP compliance.
Why soliciting a consultancy service from a member of the FDA Alumni Association?
FDA is a well-established agency with extensive expertise in medical products, including advanced therapy medicinal product (ATMP), and is internationally recognized as the leading drug regulatory agency in the world. Support of an FDAAA expert with previous experience of GMP inspection, will be a valuable asset to step-by-step guide us through the setup of our GMP manufacturing facility and to successfully pass inspection
I would like to point out that the GMP inspection that we are seeking should be accomplished by the second half of 2019.
Questions we are trying to get answers to:
- How and to which extent can an FDA Alumni Association member help us to get our facility inspected for GMP compliance?
- What would be the action plan to be ready by the second half of 2019?
- How much would the cost be? Please provide us with a detailed proposal for the services provided.
- What kind of information/documentation is required from us?
If you would like to have more information, please contact:
Manager - Quality Assurance and Regulatory Compliance
Sidra Medical and Research Center
Phone: +974 4003 7554
Mobile: + 974 6625 0606
Posting Date: 04/17