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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 30, 2015 FBO #4997
DOCUMENT

65 -- PURCHASE OF ALLOPURINOL, USP - Attachment

Notice Date

7/28/2015
 

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

VA25815Q0618
 

Response Due

8/21/2015
 

Archive Date

9/20/2015
 

Point of Contact

William Corson
 

Small Business Set-Aside

Total Small Business
 

Description

STATEMENT OF WORK (SOW) All questions must be submitted in writing via email no later than 12 August 2015 to william.corson@va.gov All quotes must be submitted in writing via email not later than the date and time shown on page 1 to william.corson@va.gov 1.SCHEDULE OF SERVICES AND/OR SUPPLIES. Products Item #Description/Part Number*Est. Qty 0001 FY15 Purchase of Allopurinol, USP175 Kgs 1001 FY 16 Purchase of Allopurinol, USP200 Kgs 2001 FY17 Purchase of Allopurinol, USP200 Kgs 3001 FY18 Purchase of Allopurinol, USP175 Kgs 4001 FY19 Purchase of Allopurinol, USP175 Kgs 2.CONTRACT TITLE. Purchase of allopurinol, USP 3.BACKGROUND. The VACSPCRPCC must purchase allopurinol, USP Active Pharmaceutical Ingredient (Allopurinol API) to manufacture 100 mg, 300 mg and 400 mg allopurinol tablets (Product) for VA research clinical trial CSP594 to study the use of allopurinol and febuxostat in veterans suffering from gout. This new VACSPCRPCC clinical trial that is expected to provide patients with allopurinol tablets for approximately 5 years. 4.SCOPE. This is a contract for the purchase of Allopurinol API which will be used to manufacture Product for VA research clinical trial CSP594, with option quantities for purchase during four additional years. The amount of Allopurinol API to be purchased will be variable and could range from a minimum order of approximately 25 kgs a year to the maximum order indicated. Because each vendor's product has different physical characteristics which impact how we manufacture the product in addition to characteristics of the finished tablets, we must use the same vendor for the life of the study. Switching Allopurinol API vendors in the middle of the study will require extensive additional costs that have not been budgeted for items such as revising regulatory submissions to the Food and Drug Administration, reformulating the product because it has different physical characteristics, additional stability testing, etc. Time is of the essence on the purchase of the Allopurinol API. Because of the tight schedule to ship product to the clinical sites in March 2016 we cannot afford to slip anywhere in the schedule. The CSPCRPCC recommends we go with the company with the shorter time frame. Purchasing from the company with the longer time frame would extend the study start-up date past our mid-March ship date. This would delay the start of a multi-million dollar study, delay veterans from obtaining the study drug and potentially impact jobs at the clinical locations. The proposed schedule includes time for Allopurinol API procurement; formulating or preparing the recipe for each Product (3 active and 3 placebo); the manufacture of pilot placebo batches for each Product; the manufacture of pilot batches for each of the three strengths of allopurinol Product; analytical testing for each Product and placebo; stability testing for each Product to determine how long the Product meets its specifications, and the manufacture, bottling, packaging and shipping of each Product and matching placebo to clinical sites throughout the U.S. in time for the initial patient enrollment. In addition the CSPCRPCC will be manufacturing other products in this time period. The Allopurinol API manufacturer must hold a Drug Master File (DMF) with the Food and Drug Administration. A DMF describes to the FDA the manufacturing processes and quality systems the vendor uses to manufacture the Allopurinol API. There are many vendors of Allopurinol API that do not have DMFs with the FDA. We cannot purchase from them for quality and safety reasons. Holding a DMF with the FDA provides the first layer of assurance that we will provide our veterans with tablet that meet our quality expectations and requirements. Because the VA does not buy tablets and capsules manufactured in India, we also cannot buy active ingredient manufactured in India or China. Many Allopurinol API manufacturers sell product in the U.S. solely through a distributor. Thus the purchase may be directly with the manufacturer or indirectly through the distributor. 5.SPECIFIC TASKS 5.1Task 1 - Regulatory Requirements 5.1.1Subtask 1 - DMF. The Allopurinol API manufacturer (or the US distributor acting on behalf of the manufacturer) must hold an active Drug Master File with the Food and Drug Administration (FDA) for the manufacture of allopurinol, USP. The Allopurinol API manufacturer cannot be located in India or China. 5.1.2Subtask 2 - FDA Registration. The facility where the Allopurinol API is manufactured must be a registered manufacturing facility with the FDA. 5.1.3Subtask 3 - FD483, EIRs or Equivalent. The manufacturer shall demonstrate that it is in good standing with the European Union and Food and Drug Administration by providing "Copies of all European Union, FD 483, or other equivalent regulatory body's inspection observations for the Allopurinol API manufacturing facility that have occurred since 2010. Redacted copies are permissible, and "Copies of all FDA Establishment Inspection Reports and other equivalent regulatory body's inspection reports that have occurred since 2010. Redacted copies are permissible. 5.1.4Subtask 4 - ISO Registration. The Allopurinol API manufacturing facility shall provide a list of ISO or equivalent registrations the facility holds. 5.1.5Subtask 5 - Quality Questionnaire. The Allopurinol API manufacturer or US distributor acting on behalf of the manufacturer shall agree to complete a quality questionnaire if required by the CSPCRPCC Quality Section. 5.1.6Subtask 6 - FDA Letter of Authorization. The Allopurinol API manufacturer (or the US distributor acting on behalf of the manufacturer) shall, upon request provide a Letter of Authorization to the FDA to allow the FDA to access the manufacturer's DMF as part of FDA's review of the Investigational New Drug Application for the clinical study conducted by the Cooperative Studies Program (CSPCRPCC) that will use the Allopurinol API. 5.1.7Subtask 7 - Copy of DMF Letter of Authorization. The Allopurinol API manufacturer (or the US distributor acting on behalf of the manufacturer) shall, upon request provide the CSPCRPCC with a copy of the manufacturer's Letter of Authorization to FDA for reviewing the Allopurinol API DMF on behalf of the CSPCRPCC. 5.2Task 2 - The Allopurinol API must meet the USP specifications 5.2.1Subtask 1 - CofA Lots Shipped. The Allopurinol API manufacturer will provide a Certificate of Analysis for each Allopurinol API lot shipped to the CSPCRPCC confirming it meets the specifications for allopurinol, USP. 5.2.2Subtask 2 - Testing. The Allopurinol API will be tested upon receipt by the CSPCRPCC to verify it meets the allopurinol, USP specifications. The product will not be officially received or payment authorized until such testing is completed. The testing will start, where possible, within 24 hours of receipt. 5.2.3Subtask 3 - CofA, 3 Historical Lots. The Allopurinol API manufacturer shall provide copies of Certificates of Analysis for three (3) allopurinol, USP lots they previously manufactured. 5.3Task 3 Expiration Dating. 5.3.1Subtask 1 - Expiration Dating. The Allopurinol API provided must have at least a three year expiration date upon receipt at the CSPCRPCC. 5.3.2Subtask 2 - Stability Testing. The Allopurinol API manufacturer shall provide documentation of stability testing on other lots that demonstrates the Allopurinol API meets the allopurinol, USP specifications for at least three years. 5.4Task 4 - SDS. The manufacturer or the US distributor acting on behalf of the manufacturer shall provide a Safety Data Sheet for the Allopurinol API and any other important information that assures the safety of the CSPCRPCC and the manufacturer's personnel when working with the Allopurinol API. 5.5Task 5 - Allopurinol API Supply. The manufacturer shall provide the amounts of Allopurinol API designated during each year of the contract which is expected to range from a minimum order of 25 Kgs to a maximum order of 175 Kgs, a year, where possible within 3months of the order date. Where possible the amount designated for each year's shipment shall come from one lot, i.e. if the required amount for 2016 is 175 Kgs, all 175 Kgs shall be from the same lot. 6.PERFORMANCE MONITORING. Allopurinol API manufacture will not be monitored. The Contractors normally manufacture large quantities of this product which they stock. Our order is considered very small. The product will be tested upon immediately upon receipt to assure that it meets the USP specifications. The product will not be received in the VA system until the testing is completed and we know the Allopurinol API passes the specifications. 7.SECURITY REQUIREMENTS. The C&A requirements do not apply. A Security Accreditation Package is not required 8.GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI). The government will not provide any equipment or information to the contractor. 9.OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. a.Identification of Possible Follow-on Work. There is no additional follow-on work expected related to this contract. b.Identification of Potential Conflicts of Interest (COI). We are not aware of any potential COI with this contract. c.Identification of Non-Disclosure Requirements. The contactor will not have access to any sensitive or proprietary information of the government in performance of this agreement. d.Packaging, Packing and Shipping Instructions. The Allopurinol API shall be shipped from the manufacturer to the attention of: Jan Hickey VA - CSPCRPCC 2401 Centre Avenue SE Albuquerque, NM 87106 U.S.A. Shipments are accepted from 7:30 a.m. to 3:30 p.m. local time. The Allopurinol API shall be shipped in appropriate containers to prevent contamination or degradation of the product and to protect the product from damage. e.Inspection and Acceptance Criteria. Contract performance shall be confirmed by: a.Verification on the FDA website that the manufacturer holds a DMF. b.Review of each Certificates of Analysis upon receipt of each lot of Allopurinol API to assure each shipment meets USP requirements. c.Receiving testing at the CSPCRPCC on each lot to assure the product received meets the allopurinol, USP specifications 10.RISK CONTROL. There is no patient risk involved with the purchase and manufacture of this product because the work in not being performed in a patient setting. The Allopurinol API will be tested to assure it meets its specifications upon receipt. Tablets made from the Allopurinol API will also be tested to assure they meet the USP specifications for Allopurinol tablets. They will be manufactured following FDA's Good Manufacturing Practices regulations and released by our Quality Section prior to being sent to patients. 11.PLACE OF PERFORMANCE. The Allopurinol API will be manufactured at the Contractor's site. 12.PERIOD OF PERFORMACE. Base Year: FY2015 1st Option PeriodFY2016 2nd Option PeriodFY2017 3rd Option PeriodFY2018 4th Option Period FY2019 13.DELIVERY SCHEDULE. First delivery (FY15) must take be delivered not later than 16 November 2015. SOW Task #Deliverable TitleFormatNumberCalendar Days After CO Start 1Subtask 2: FDA Registration. The contractor will provide a copy of their FDA registration for the facility in which the Allopurinol API is manufactured.Electronic Copy1 to SME28 1Subtask 3: FD483, EIRs or Equivalent. The contractor will provide a redacted copy of a.All inspection observations made by the FDA or equivalent regulatory body. b.All Establishment Inspection Reports or other inspection documents made by the FDA or equivalent regulatory bodies.Electronic Copy1 to SME28 1Subtask 4: ISO Registration. The contractor will provide a list of ISO and other equivalent registrationsElectronic Copy1 to SME28 1Subtask 5: Quality Questionnaire. The contractor will complete a CSPCRPCC Quality Questionnaire and return it to the CSPCRPCC upon request.Electronic Copy1 to SME, 1 to Chief of Quality28 days after Quality Questionnaire provided to Contractor 1Subtask 6: FDA Letter of Authorization. The contractor will provide a letter of authorization to FDA to review the Allopurinol API Manufacturer's DMF on behalf of the CSPCRPCC.Confirmation email that the letter has been sent to FDA1 to FDA28 1Subtask 7. Copy of DMF Letter of Authorization. The contractor will provide the CSPCRPCC with an "original" copy of the letter of authorization they send to the FDA."Original"1 to SME28 2Subtask 1. CofA Lots Shipped. The Allopurinol API manufacturer will provide a copy of the Certificate of Analysis for each lot of product shipped to the CSPCRPCC.Electronic Copy1 to SMEUpon shipping each Lot 2 Subtask 2. Testing The CSPCRPCC will test each lot of allopurinol, USP upon receipt to assure it meets the USP specification.Testing provided by VAConfirmation Testing Passed provided to Contractor's RepresentativeN/A 2Subtask 3. CofA, 3 Historical Lots. The Allopurinol API contractor will provide copies of Certificates of Analysis for three lots of API that have been previously manufacturedElectronic Copy1 to SME28 3Subtask 1. Expiration Dating. The Allopurinol API must have at least 3 years of expiration dating left upon receipt at the CSPCRPCC.Visual Verification Upon Receipt and Electronic Copy of the CofA1 to SMEUpon shipment and receipt of each lot 3Subtask 2. Stability Testing. The Allopurinol API manufacturer shall provide documentation of stability testing on other lots that demonstrates the Allopurinol API meets the allopurinol, USP specifications for at least three years.Electronic or Paper Copies of Data1 to SME28 4Task 4. SDS. The manufacturer or the US distributor shall provide a Safety Data Sheet for the Allopurinol API and any other important information that assures the safety of the CSPCRPCC and the manufacturer's personnel when working with the Allopurinol API.Electronic Copy1 to SME28 5Task 5. Allopurinol API Supply. The manufacturer or U.S. distributor shall provide the amount of Allopurinol, API meeting the specifications, as defined in the base year and each option year. Where possible, each year's designated amount will come from one lot.Verification upon receipt.N/A 14 or as agreed with CO, COR and SME subject to holidays and custom's release 14.ACRONYMS. A.API - Active Pharmaceutical Ingredient. The ingredient in a drug product that provides the chemical effect on a human body to treat a disease. B.CMS - Clinical Manufacturing Section. C.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. D.CofA - Certificate of Analysis. A Certificate of Analysis provides the tests, the specifications for the tests, the test results and shows if the product passed or failed. E.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. F.CSPCRPCC - Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. G.DMF - Drug Master File. Companies that manufacture API file DMFs with the FDA that show the manufacturing processes, procedures and quality testing and verification for their product(s). H.FD 483 - Food and Drug 483. A form on which FDA investigators list the audit observations they make when inspecting a facility they regulate such as an API manufacturer or a commercial drug product manufacturer. Review of these observations allow potential customers to gain an idea of the conditions under which the product is manufactured. I.FDA - Food and Drug Administration. The CSPCRPCC is registered with the FDA to manufacture drug products. As such the CSPCRPCC must meet all FDA regulatory requirements for drug product manufacture and testing. J.Kgs - Kilograms. A unit of weight used in the metric system and in drug manufacturing. K.OCD - Office of the Center Director L.SDS - Safety Data Sheet. M.USP - United States Pharmacopeia - The recognized source of specifications and test procedures for most established pharmaceutical products.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25815Q0618/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-15-Q-0618 VA258-15-Q-0618_2.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2196111&FileName=VA258-15-Q-0618-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2196111&FileName=VA258-15-Q-0618-000.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: Department of Veterans Affairs;2401 Centre Ave;Albuquerque, NM

Zip Code: 87106
 

Record

SN03813697-W 20150730/150729000134-38678e76a6c044b424a5a73ef5995b33 (fbodaily.com)
 

Source

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

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