Sample_Task_Order.pdf
PDF 88 KB Posted
- Attached to
- Drug Formulation and Manufacturing Program Federal contract opportunity
- Solicitation number
- 75N98019R00005
About this file
This document contains a statement of work for a sample task order and a related federal contract opportunity notice. The statement of work outlines process development, formulation development studies, and manufacturing of clinical trial material for a drug compound. Specifically, it requires proposing and performing process development to manufacture 10,000 capsules or 3,000 injectables of the drug while adhering to cGMP guidelines. It also requires proposing and conducting preformulation studies to increase the compound's exposure in preclinical and IND-enabling studies, as well as formulation development, manufacturing of cGMP clinical trial material as tablets or sterile injectable solution, and specific plans for labeling, storage, and distribution. The related federal contract opportunity is a pre-solicitation notice for multiple award ID/IQ contracts to develop and manufacture investigational drug candidates for preclinical, IND-enabling, and clinical studies. It is being conducted under FAR 15 and has a NAICS code of 325412 with a size standard of 1,250 employees. It is intended as a partial small business set-aside, and the goal is to complete manufacturing, documentation, formulation, fill and finish, packaging, and labeling for investigational drug compounds in compliance with FDA, WHO, and ICH policies.
Attachment 2: Sample Task Order
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Q&A.pdf | ||
| sectionk_june2017.pdf | ||
| 75N98019R00005_Amendment_0002.pdf | ||
| 75N98019R00005.pdf | ||
| 75N98019R00005.pdf | ||
| DFMC_Final.pdf | ||
| Proposal_Intent_Response_Form.pdf | ||
| Quality_Agreement_template.pdf |
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Text version
STATEMENT OF WORK FOR SAMPLE TASK ORDER #002-1
DRUG MANUFACTURING AND FORMULATION PROGRAM
SCOPE
Studies conducted under this Sample Task Order shall be used to conduct process development to establish formulation as a solid dosage form or injectable form, perform analytical method development for assay and/or dissolution, and perform manufacturing of the drug product following by the stability program listed below in accordance to ICH Quality Guidelines.
Ref: Med. Chem. Lett. 2011, 2, 929-932
The proposal should consider manufacture of clinical trial material, packaging, labeling, storage and distribution.
TECHNICAL REQUIREMENTS
Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform the activities below:
Background: The compound above is a test compound. It was originally designed as a potent agonist of 5-HT2C lacking 5-HT2B activity.
Specifically, the Contractor shall:
• Propose and perform process development to enable manufacturing of the drug product at 10,000 capsules or 3,000 injectables while adhering to the cGMP guidelines.
• Propose and perform preformulation and preclinical formulation development studies to increase exposure of the compound (e.g. studies to increase solubility and permeability etc.) in preclinical and IND enabling studies.
• Propose and perform formulation development studies, manufacture of GMP clinical trial material of tablets, packaged in blister packs, and sterile injectable solution in vials. The proposal should include specific label, storage, and distribution plans.
[End of Statement of Work for Sample Task Order #002-1]
REPORTING REQUIREMENTS AND DELIVERABLES FOR SAMPLE TASK ORDER
#002-1
A. Technical Reports
In addition to those reports required by the other terms of this Task Order, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE C.2., Reporting Requirements.
All reports required herein shall be submitted to the Contracting Officer (CO) and Contracting Officer’s Representative (COR) in electronic format.
Task Order Final Report
A Task Order Report is due on or before the completion date of the Task Order and shall describe the work accomplished under the Task Order. The Task Order Report shall include:
• A cover page listing:
o Base contract and Task Order titles and numbers;
o Type of report;
o Contractor’s name and address; and o Date of submission;
• A table of contents;
• An introduction describing the goals of the Task Order;
• A detailed description of methodology of techniques used;
• Results and a discussion of their significance;
• A description of problems encountered and their solution; and
• Representative spectra, chromatograms, and other charts/tracings from analytical instrumentation.
• Manufacturing batch record
• Stability program
| STATEMENT OF WORK FOR SAMPLE TASK ORDER #002-1 DRUG MANUFACTURING AND FORMULATION PROGRAM |
| TECHNICAL REQUIREMENTS |
| [End of Statement of Work for Sample Task Order #002-1] |
| Task Order Final Report |
File details come from the government source that posted it. Updated .