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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 02, 2015 FBO #4969
DOCUMENT

65 -- FORMULATIONS & BATCH RECORDS REQUEST FOR INFORMATION ONLY - Attachment

Notice Date

6/30/2015
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25815N0578
 

Response Due

7/9/2015
 

Archive Date

8/8/2015
 

Point of Contact

Steven.Turner3@VA.GOV
 

E-Mail Address

Steven.Turner3@VA.GOV
(Steven.Turner3@VA.GOV)
 

Small Business Set-Aside

N/A
 

Description

"This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Request for Information/ Sources Sought Please review the Statement of Work below and identify if this is a requirement that your firm could provide services to support. Please include Point of Contact Information and the Size/Socio Economic Status of your Firm. If you find any discrepancies or concerns with the Statement of Work please note that as well. Please email responses to: Steven.Turner3@VA.Gov STATEMENT OF WORK 1.CONTRACT TITLE. Provision of Clinical Trial Product Formulations and Batch Records (FBR) Five (5) year IDIQ contract firm fixed price contract for each CLIN. 2.BACKGROUND. The Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy coordinating Center (CSPCRPCC) manufactures tablets, capsules and other oral dose products for Veteran patients to consume when participating in clinical trials. If we compared this contract to baking cookies, this contract is for the purchase of the recipe (batch record) which includes the amount of each ingredient (formulation) contained in both the batter and in each cookie; and the step by step instructions for how to make the batter and cookies. The CSPCRPCC does not have the in-house expertise to define the FBR for the products we manufacture. Thus we need to hire an organization with this expertise that will provide us with the FBR for each product. 3.SCOPE. The CSPRPCC needs a five (5) year IDIQ contract with firm, fixed pricing for each CLIN for purchasing clinical trial FBRs. The IDIQ allow flexibility in the number of FBRs purchased, flexibility in ordering the FBRs after the requirements materialize, and they limit the Government's obligation to the minimum quantity specified in the contract. The scope of work includes: "Manufacturing placebo tablets, "Manufacturing placebo capsules, "Manufacturing capsules containing one or more Active Pharmaceutical Ingredients (API) "Manufacturing tablets containing one or more APIs "Coating tablets "Overencapsulating commercially available capsules or tablets "Overencapsulating placebo tablet or capsules. FBRs for new chemical entities will not be covered under this agreement. The work covered by this contract involves well characterized products that are commercially available. They may involve providing the FBR for a product in a different dosage form or strength than is commercially available. For example 100 mg and 300 mg Allopurinol products are commercially available. There may be a requirement for providing FBRs for 100 mg, 300 mg and a 400 mg Allopurinol tablet. The 400 mg tablet is not commercially available. The work could involve products that are controlled substances or hazardous. The CSPCRPCC will not handle materials more hazardous than those with an exposure limit of 10<100 µg/m3. Over the last five years the CSPCRPCC has required from one to eight FBRs each year. The requirements vary each year depending on: a.The clinical trials funded, b.The clinical trial requirements to manufacture or not manufacture drug products. c.The types of drug products that need to be manufactured, d.The number of different drug products that need to be manufactured to meet each clinical trial's requirements. Formulations The various types of FBRs that may be required are listed in this SOW under Section 3 Schedule of Supplies. Batch Records The contractor will use the CSPRPCC batch record templates for each type of product manufacture, i.e. manufacture of a placebo tablet, manufacture of a capsule with API. Samples of batch records which are representative of those used by the CSPCRPCC are provided in Exhibits 1 to 5 as follows: Exhibit 1 - Placebo Tablets Exhibit 2 - Coating Tablets Exhibit 3 - Active Capsule Filling on Bosch Exhibit 4 - Capsule Filling on the Ultra 8II Exhibit 5 - Tablet Overencapsulation on the Ultra 8II Items the batch records currently need to include are: Batch Record TypeRequirements Tablet ManufactureThe batch record shall include: "The equipment to use including the blender, sieve sizes, etc. "The range for the theoretical batch size. This is based on the requirements of the study and the blender used. "The raw materials, components or ingredients "The percentage of each raw material, component or ingredient in each tablet "The target tablet weight, thickness and hardness "The quantity by weight of each ingredient in each tablet "The tolerances for the tablet weight, thickness, hardness and for each ingredient "The step by step procedures for manufacturing the tablet, including the order of addition of raw material, blend time, sieving, etc. as required. Tablet or Capsule CoatingThe batch record shall include: "The appropriate coating pan to use. "The range for the theoretical batch size. This is based on the requirements of the study and the coater to be used. "The components or ingredients "The percentage of each component or ingredient required to coat each tablet "The target tablet weight gain (i.e. 3%) "The quantity by weight of each ingredient that will be added to each tablet "The step by step procedures for mixing the coating and applying it to the tablet or capsule, including items such as mixing time, recommended inlet temperature, air volume, pan speed, pan pressure, pan jog, pump speed, atomizing air and spray gun pattern air. Capsule Manufacture The batch record shall include: "The blender to use. (NOTE: some placebo capsules may use only one ingredient. The powder would not be blended. It would be gravity filled into the capsules). "The range for the theoretical batch size. This is based on the requirements of the study and the blender to be used. "The components or ingredients "The percentage of each component or ingredient in each capsule "The capsule that will be used "The target powder fill weight "The tolerances for the fill weight and for each ingredient "The quantity by weight of each ingredient in each capsule "The step by step procedures for manufacturing the capsule, including items such as blend time, sieving. "Recommended tamping pin size "Recommended dosing bowl height "Recommended compression setting Overencapsulation - Ultra 8IIThe batch record shall include: "The blender to use if needed. Capsules containing overencapsulated product may be filled with one excipient that will not require blending. "The range for the theoretical batch size. This is based on the requirements of the study. "The components or ingredients "The percentage of each component or ingredient in each capsule "The capsule that will be used "The tolerances for the fill weight for each ingredient "The target weight of the finished capsule "The step by step procedures for overencapsulating the capsule or tablet. Based upon changing requirements at the CSPRPCC, audit findings, International Standards Organization (ISO), FDA and other regulatory agency expectations, the contents of the batch record will change over time. These changes will be communicated to the contractor by the CSPRPCC in a timely manner so the contractor may incorporate them into batch records provided after the changes are made. Equipment The FBRs must be developed to utilize the CSPCRPCC manufacturing equipment. A list of equipment owned by the CSPCRPCC is found in: Exhibit 6 - Manufacturing Equipment The equipment list will be modified over time when equipment is replaced or new equipment is added. The CSPRPCC will work with the contractor to assure they are made aware of all new or obsoleted equipment. Reports: The contractor will be expected to provide a summary report of the work. 4.SPECIFIC TASKS. The formulation development work should consist of one or more of the following tasks each year. 4.1Task 1 - CLINS 1 - 30. Provide FBR and Summary Report 4.1.1Subtask 1 - Evaluate Formulation Information - Contractor will evaluate literature for commercial product when available and/or evaluate literature available applicable to the product. Contractor will evaluate properties of the API such as crystal structure or shape, water and/or oxygen sensitivity, etc. Contractor will evaluate appropriate raw materials to use by looking at raw materials contained in commercial product when available, evaluating raw materials appropriate to the product,, evaluating raw materials normally stocked by the CSPCRPCC, etc.. 4.1.2Subtask 2 - Provide FBR - Contractor will provide the CSPCRPCC with the FBR which will include, but not be limited to: the equipment to use, the range for the theoretical batch size, the raw materials to use in the formulation, the amount of each raw material to use, the amount of API to use in the formulation, the percentage of each material in the formulation, the physical specifications for the product being made (i.e. in-process and finished product weight, thickness, and hardness specification ranges and targets for tablets) the step by step instructions for making each product the order of addition or raw materials, blend time, sieving, etc. 4.1.3Subtask 3 - Report. - Contractor will provide the CSPRPCC with a summary report of the work conducted for each FBR provided. 4.1.4Task 2 - CLINS 31 - 33. Provide Samples. Contractor will provide the CSPCRPCC with 600 capsules or tablets made using the formulation for evaluation. 5.PERFORMANCE MONITORING. The CSPCRPCC will monitor performance by conducting periodic phone calls with the contractor when FBR work is ongoing. Product quality will be verified on receipt by manufacturing and testing product made with the FBR and by analyzing the summary report. 6.SECURITY REQUIREMENTS. The C&A requirements do not apply. A Security Accreditation Package is not required 7.GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI). The following items may be provided to the contractor to fulfill the requirements: a.Small quantities of Active Pharmaceutical Ingredient b.Small quantities of raw materials such as starch, cellulose and other ingredients c.Small quantities of capsules d.One or two sets of tooling for a tablet press for tablet Product e.Product information such as preferred batch sizes f.Product specifications such as drug strength for active tablets g.Samples of tablets, capsules or other oral products for which we will make similar placebo products or active products 8.OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. The contractor providing the FBRs must use individuals to perform the work with demonstrated experience developing solid oral dosage form products (tablets and capsules) for clinical trials regulated by FDA, the EU and other international regulatory agencies. The contractor should have demonstrated experience providing FBRs for the equipment owned by the CSPCRPCC. The contractor should be available to respond to questions essentially immediately regarding the FBR if problems arise during manufacturing or testing. a.Identification of Possible Follow-on Work. Possible Follow-on-Work would be for FBRs not covered under this contract such as products using new chemical entities. Such a contract is not expected. b.Identification of Potential Conflicts of Interest (COI). No organizational Conflict of Interest exists. c.Identification of Non-Disclosure Requirements. The contractor will not have access to sensitive or proprietary information. The FBRs will not contain proprietary information. d.Packaging, Packing and Shipping Instructions. Product shall be shipped from the manufacturer to the attention of: Jan Hickey VA - CSPCRPCC 2401 Centre Avenue SE Albuquerque, NM 87106 U.S.A. 505-248-3203 Shipments are accepted from 7:30 a.m. to 3:30 p.m. local time. Tablets or capsules shall be shipped in appropriate containers to prevent contamination, degradation or shipping damage. e.Inspection and Acceptance Criteria. The CSPCRPCC will evaluate the Product delivered by: "Reviewing the FBRs provided, "Manufacturing pilot or other batches of product using the FBR provided, "Testing the product the CSPCRPCC manufactures using the FBR to assure it meets the requirements. "Testing the 600 tablets or capsules, if requested. "Reviewing the Summary report. 9.RISK CONTROL. The CSPCRPCC will minimize risk to Veteran patients taking drug products manufactured using the FBR provided under this contract by: 1.Manufacturing the product using the FBR provided. 2.Testing all product manufactured to assure it meets the in-process and finished product specifications. 3.Entering all process and product deviations, out of specification results, etc. into our Corrective and Preventive Action (CAPA) system, reviewing and correcting these items, documenting all changes appropriately and completing other actions as required to assure the products are safe. 10.PLACE OF PERFORMANCE. The work will be performed at the Contractor's facilities. 11.PERIOD OF PERFORMACE. Start DateAugust 31, 2015August 30, 2016 Option Year 1August 31, 2016August 30, 2017 Option Year 2August 31, 2017August 30, 2018 Option Year 3August 31, 2018August 30, 2019 Option Year 4August 31, 2019August 30, 2020 12.DELIVERY SCHEDULE. SOW Task #Deliverable TitleFormatNumberCalendar Days After CO Start& IDIQ Request Made 1CLINS 1-30, Subtask 2 - Provide FBR Electronic copy130 days after request made unless multiple requests made on same date. Dates then to be staggered with first request completed within 30 days, and additional requests received every 7 days after that. The CSPRPCC will prioritize the requests. 1CLINS 1-30, Subtask 3 - ReportElectronic copy145 days after request made unless multiple requests made on same date. Dates then to be staggered with first request completed within 45 days, and additional requests received every 7 days after that. The CSPRPCC will prioritize the requests. 2CLINS 31 - 33. Provide Samples. As required by product to be manufactured600 eaches35 13.ACRONYMS. A.CO - Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts. B.COR - Contracting Officer's Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract. C.CSPCRPCC - Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. D.VAMC - Department of Veterans Affairs Medical Center E. NMAHCS - New Mexico Veterans Affairs Healthcare Sys "This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25815N0578/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-15-N-0578 VA258-15-N-0578_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2141023&FileName=VA258-15-N-0578-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2141023&FileName=VA258-15-N-0578-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: VA Medical Center Albuquerque New Mexico

Zip Code: 87108
 

Record

SN03781124-W 20150702/150630235435-1d5869cbeceb22853d28141d2b9e45f5 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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