FILE | B | Quality by Design Study - Figure 1 QbD for Parenterals - The Approach

FBO DAILY ISSUE OF JUNE 13, 2008 FBO #2391
DOCUMENT

B -- Quality by Design Study - Figure 1 QbD for Parenterals - The Approach

Notice Date: 6/11/2008
Notice Type: Figure 1 QbD for Parenterals - The Approach
NAICS: 541690 — Other Scientific and Technical 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-08-00747
Archive Date: 7/4/2008
Point of Contact: David - Kordel, Fax: 301-827-7151
E-Mail Address: david.kordel@fda.hhs.gov
Small Business Set-Aside: Total Small Business
Description: FDA-SOL-08-00747 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: Project Title: Development of Quality by Design (QbD) Case Studies and Guidance Elements on Parenteral Dosage Forms Purpose: To reach a better understanding of the concept of Quality by Design (QbD) and how this can be applied to the most common parenteral manufacturing processes. Background: Pharmaceutical manufacturing is going through a major transition from quality assessment by testing the product at the end of manufacture to the more holistic control strategy of Quality by Design (QbD) and Process Analytical Technology (PAT). There is greater realization that an enhanced understanding of the pharmaceutical processes involved in product manufacture and in particular, appreciation of criticality of the process steps and the critical process parameters that control each of these steps are of vital importance to ensuring quality of manufactured products. With the advent of QbD, each pharmaceutical company is likely to implement science and risk based approaches to evaluate its own processes, determine their critical steps and necessary controls and establish a design space for each process. It is essential therefore, that companies have a common understanding to make the review process more consistent. Description of Work: The design for the study is shown in Figure 1 below. A typical Active Pharmaceutical Ingredient (API) that is widely available and is representative will be picked for this study. Figure 1: QbD for Parenterals – The Approach The study will involve the following steps: 1. Define the Critical Product Attributes of the Target Product Profile. The target product profile would include: a.Assay i.API source and control strategy b.Complete recovery of API activity upon reconstitution For small molecules, this is generally not a problem. For large molecules, and particularly for vaccines, it can be an unrealistic goal, and we can only strive for consistent recovery of activity. In cases where the concentration of formulation excipients is very low, or where organic co-solvent systems are used, powder ejection from the vial during freeze drying can be a significant issue c.Reconstitution i.Influence of formulation components ii.Thermal history of freezing iii.Potential effect of collapse, or micro-collapse, on reconstitution time d.Freedom from extraneous particulate matter i.May be related to slow, or incomplete, reconstitution Instability of freeze-dried solid can lead to particulate matter in reconstituted solid e.Stability i.Effect of residual moisture in freeze-dried solid Potential for transfer of moisture from stopper to freeze fried solid ii.Effect of vial headspace composition 2. Propose a formulation using key formulation design decisions. 3. Propose the manufacturing process. 4. Conduct a risk analysis using cause and effect process (Ishikawa diagram) to identify the variables that are like to impact the manufacturing process. 5. Risk Evaluation – classify the unit operations that are likely to have an impact on quality. 6. Identify the critical operating variables and material property variables that are like to have the maximum impact on the Critical Product Attributes. (Risk evaluation study using Risk = probability X impact and FMEA) 7. Design of Experiments. 8. Conduct the experiments in laboratory/pilot plant equipment. 9. Develop Formulation Design Space and Lyophilizer Design Space. 10. Propose control strategy to reduce risk. Deliverables: 1. Monthly teleconferences shall be on the 1st day of the month in the mornings (TBD). a.Shall maintain an on-going dialogue by communicating with the project officer & key study personnel via e-mail or telephone as necessary in order to provide periodic updates of study progress, status, and interim results related to various phases of the study. 2. Quarterly project reports in Word document shall be submitted to the project officer & key study personnel by the first day of the month (Q1 for method development, Q2 for formulation optimization, Q3 for process optimization, Q4 for final report). a.Keep and maintain all raw data collected during the performance of the study in laboratory notebooks and/or CDROM. 3. A final report in Word document shall be submitted to the project officer & key study personnel two weeks prior to the end of the 12-month time period of the study. 4. Presentation at the FDA of the final results shall be two weeks after the 12-month time period of the study. 5. Expect 1-day site visit from the project officer and/or key study personnel at vendor site at the 3-month and 9-month time periods of the study. 6. Vendor shall visit FDA facility in Silver Spring, Maryland for seminar presentation in PowerPoint format and/or for face-to-face discussion of the project at the 11-month time period of the study. 7. FDA retains full data rights to all information related to this study, including any subcontract works. Performance period: one year from the time of award. 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 specifics for this study. 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 541690 (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 June 19, 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.
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Document(s): Figure 1 QbD for Parenterals - The Approach; File Name: Figure 1 (SS_QbDStudy_Fig1.doc); Link: https://www.fbo.gov//utils/view?id=9cbe24d18a1876dbffd161516612d9d2; Bytes: 47.50 Kb; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Record: SN01591146-W 20080613/080611221533-92d94e40a0a55083d1794c18df01be17 (fbodaily.com)
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B -- Quality by Design Study - Figure 1 QbD for Parenterals - The Approach