SOLICITATION NOTICE
B -- Assessing Risks of Changing Sterile Drug Manufacturing Sites
- Notice Date
- 5/13/2008
- Notice Type
- Presolicitation
- NAICS
- 541618
— Other Management Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-08-00641a
- Point of Contact
- David - Kordel, Fax: 301-827-7151
- E-Mail Address
-
david.kordel@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- Requisition Number: FDA-SOL-08-00641a The Food and Drug Administration (FDA) is seeking Full and Open Competition for vendors to write an analytical report on Sterile Drug Manufacturing sites. The purpose is to demonstrate risks due to changing the manufacturing site can be managed strictly within the manufacturer's change control process so that a supplement to an application is not required. Changing sterile drug product manufacturing sites poses risks to product safety and quality. Currently, changing manufacturing locations is considered a "major" change, requiring a company to submit a supplement to an application. The Office of Pharmaceutical Science (OPS) has embraced Quality by Design (QbD) to ensure that risks associated with manufacturing changes are managed within the manufacturer's internal change control process. OPS reviewers make decisions on product safety and quality based on how a manufacturer describes site specific changes to their sterile manufacturing process. OPS reviewers require detailed information regarding the proposed manufacturing facility, the manufacturing process, the methods by which the processes will be validated, and the expected outcome of validation studies. Specifically, the vendor shall demonstrate how changing the manufacturing site for sterile drug products can be managed strictly within manufacturer's internal change control process. The authorization to do this would be granted through approval of a risk management plan. Risks include sterility assurance failures due to variations in the facility, manufacturing process, design space and/or process control strategies (e.g. validation, sampling, monitoring, and acceptance criteria), and the introduction of impurities to the drug product as a result of changes, raw materials, equipment, and/or container closure components. The vendor shall describe a way to make manufacturing site changes using change control processes that are part of Current Good Manufacturing Practices (CGMP). To accomplish this goal, the vendor shall interview industry experts and OPS review staff. The vendor shall then document the findings, using ICH Q9 Risk Management and OMB/OSTP's "Updated Principles for Risk Analysis." Following development of a work plan, the tasks will be divided into a data gathering process and summary, followed by the risk management draft document for each product class (synthetic and biotech). The selected vendor will have a record of brining together a wide range of groups and people to generate consensus through workshops and/or forums. The performance period will be one year from the time of award. The NACIS code for this work is 541618. Vendor’s response to this RFQ must be limited to no more than 10 pages. This is a REQUEST FOR QUOTATION (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 5:00 pm (1600) EST on May 19, 2008. All responsible sources must be registered in the Central Contractor Registry System (CCR) at www.ccr.gov to be considered. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 10:00 AM (1000) EST on 28 May 2008 to the attention of David Kordel, david.kordel@fda.hhs.gov. Evaluation/Award will be based on the technically acceptable quote that offers the best value to the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures.
- Web Link
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- Record
- SN01572085-W 20080515/080513220831-d4a1044336c953045459fb471bb6279c (fbodaily.com)
- Source
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