SOURCES SOUGHT
B -- Assessing Risks of Changing Sterile Drug Manufacturings Sites
- Notice Date
- 5/6/2008
- Notice Type
- Sources Sought
- 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-08-00641
- Point of Contact
- David - Kordel,, Phone: 301-827-7166
- E-Mail Address
-
david.kordel@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- FDA-SOL-08-00641 This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) that can provide the following analytical report: 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 performance period will be one year from the time of award. The NACIS code for this work is 541618. The NAICS Code is 541618 interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents capacity and capability to provide the required specific instrument. Responses to this notice shall be limited to 15 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541618 (size standard, $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. THIS NOTICE IS FOR PLANNING PURPOSES ONLY, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses must be sent to this notice no later than 10:00 a.m. EST on May 12, 2008 submitted by email to the attention of David Kordel, Contract Specialist for consideration. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
- Web Link
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