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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 07, 2014 FBO #4486
MODIFICATION

68 -- API, N-ACETYLCYSTEINE, USP GRADE

Notice Date

3/5/2014
 

Notice Type

Modification/Amendment
 

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

VA25814Q0240
 

Response Due

3/19/2014
 

Archive Date

4/18/2014
 

Point of Contact

William Corson
 

Small Business Set-Aside

N/A
 

Description

STATEMENT OF WORK (SOW) 1.SCHEDULE OF SERVICES AND/OR SUPPLIES. Item/Stock#DescriptionEst. Qty.UnitUnit PriceEstimated Amount API NAC USPActive Pharmaceutical Ingredient (API), N-Acetylcysteine (NAC), USP grade Note: the NAC needs to be purchased from an authorized U.S. distributor for MOEHS Iberica S.L.(Moehs) in Spain, the API manufacturer. Moehs will ship the API to contractor. Contractor will ship the NAC to: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106 The price must include: o One 50 Kg drum of the API, NAC, USP grade o Delivery to the VA CSPCRPCC o Minimum expiration dating of 48 months remaining upon receipt at the VA CSPCRPCC o Customs Broker, Customs Clearance & Shipping fees, includes: --Shipping from the manufacturer (MOEHS) to the U.S. Port of Entry --Customs fees for export/import duty --All Customs Broker fees associated with export/import 50KG TOTAL ESTIMATED COST ? 2.CONTRACT TITLE. API, N-Acetylecysteine (NAC), USP grade 3.BACKGROUND. The VA Cooperative Studies Program (VA CSP) is the Division of VA Research and Development responsible for planning large clinical trials which they conduct at numerous clinical locations for the Department of Veterans Affairs. The CSPCRPCC purchased this NAC manufactured by MOEHS Iberica S.L.(MOEHS) in Spain from Interchem Corporation in 2013 (501-D30001) and 2012 (501-D20026) under Contract # VA 258-12-C-0070 to manufacture 300 mg capsules for use in the CSP # 578 clinical research trial (study) for the "Prevention of Serious Adverse Events Following Angiography: A Department of Veterans Affairs Cooperative Study (PRESERVE)." Because two lots of the product were lost due to formulation and manufacturing problems, the CSPCRPCC needs additional MOEHS Iberica S.L. (MOEHS) API, NAC, USP grade, to make additional 300 milligram capsules to allow completion of the study by veteran patients. 4.SCOPE. Work on the CSP # 578 clinical research study for the "Prevention of Serious Adverse Events Following Angiography: A Department of Veterans Affairs Cooperative Study (PRESERVE)" started approximately two years ago. When the study started, the CSPCRPCC's Clinical Materials Manufacturing Section believed that 100 Kg would be more than adequate to manufacture all the 300 mg tablets required for the study. A number of problems were encountered when manufacturing the first two lots of product which were not expected when planning the project, resulting in the loss of both lots. Because of the loss of the first two lots, the 100 Kg of NAC originally planned to provide capsules for the entire study is no longer adequate. Thus an additional 50 Kg of the API, NAC, USP grade must be ordered to complete the study. The CSPCRPCC needs to purchase the API, NAC, USP grade from the same manufacturer that originally provided it. We require the use of the same manufacturer because: a.If we change API manufacturers, we must notify the FDA of the change. The FDA must approve the use of a new API manufacturer for the study. The API manufacturer currently used in the study is listed in the Investigational New Drug (IND) regulatory submission to the Food and Drug Administration as the manufacturer of the API. The FDA requires certain data to be collected and submitted in the IND for the API manufacturer. We do not have time to obtain this data, submit it to the FDA, and wait for FDA to allow continuation of the trial using a new API manufacturer. b.If we change API manufacturers we will probably need to alter the product formulation because each API manufacturer has a different method for synthesizing or making their active ingredient. The differences in the manufacturing process include crystal structure, size, shape, flow characteristics, etc. These changes will require reformulation of the 300mg API capsule which is an expensive and time consuming process that was not budgeted. c.Reformulation of the 300 mg capsule could potentially result in the loss of additional capsule lots. d.The differences between different manufacturer's API resulting in different formulations could also bias the clinical trial (study) results. e.This study is also being conducted in Australia. If we change API manufacturers, the Australian regulatory equivalent of the FDA must approve the use of a new API manufacturer for this clinical trial. Thus if we change API manufacturers we would be required to also submit extensive information to the Australian regulatory authorities and wait for their approval to continue the study in Australia. f.There is a potential that either the FDA or the Australian regulatory authorities would require the CSPCRPCC to conduct a bioequivalence study to show the API made by the new manufacturer is equivalent to the API made by the previous manufacturer. Bioequivalence studies could easily cost in excess of five hundred thousand dollars which is not available for this study. g.The company manufacturing the API, NAC, USP grade must have a Drug Master File (DMF) on file with the U.S. Food and Drug Administration (FDA). The DMF demonstrates to the FDA how the manufacturer meets the regulatory, processing, quality and safety requirements for the manufacturing of the API, NAC, USP grade. 1.MOEHS, the company that provided the API currently used in the CSP # 578 clinical research study has a DMF on file with the FDA. 2.When the CSPCRPCC submitted their IND to FDA to obtain authorization to conduct the clinical trial, MOEHS, through their distributor Interchem Corporation gave FDA the right to review their DMF for the CSP # 578 clinical research study. 3.Three companies from which the CSPCRPCC will purchase product hold DMFs for NAC. 4.We only have permission from the company that provided the original API to allow the FDA to access their DMF. If we changed to another manufacturer we would need to ask that company to provide the FDA authorization to access their DMF as it relates to our IND. We would need to obtain additional information from the new company including but not limited to stability data on their API. We would need to update our IND to reflect the new company, stability data, test methods, specifications and results and any other applicable information and submit it to FDA. This process takes months to occur delaying and possibly halting the clinical trial in addition to requiring numerous labor hours which were not budgeted for the study. 5.Our experience is that each API manufacturer has differences in their analytical methods. Assuming there are differences we would need to revalidate our analytical methods and alter our test procedures which would require additional unbudgeted labor hours. The CSPCRPCC needs to immediately purchase one 50Kg drum of the API to manufacture 300 milligram capsules for use in the CSP # 578 clinical research study. The CSPCRPCC would like to receive the API in-house no later than March 1, 2014 to allow enough time to manufacture, bottle, label, package, and ship the 300 milligram capsules to U.S. and Australian clinic locations participating in the CSP # 578 clinical research study so they can dispense the product to veteran and Australian patients before the current drug either expires or we run out of inventory. Any delay to obtaining the 50 Kg drum of API, NAC, USP grade will seriously impact the mission of the VA Cooperative Studies Program and the health of the veterans enrolled in this clinical research study by delaying research designed to prevent serious adverse events following angiography. The research study budget which includes providing veteran patients with drug product also supports employee salaries. Stopping the study would stop financial support for many employees. 5.SPECIFIC TASKS. 5.1Task 1 - Purchase API, N-Acetylcysteine (USP grade). Contractor will provide one lot of 50Kg of N-Acetylcysteine, USP grade purchased from MOEHS Iberica S.L. (Moehs) in Spain for delivery to the CSPCRPCC no later than March 1, 2014. 5.1.1Subtask 1 - Expiration Dating. The NAC must have an expiration date of not less than 48 months when received by the CSPCRPCC. 5.1.2Subtask 2 - USP Specifications. The NAC must meet all current USP specifications/standards and must be manufactured under current Good Manufacturing Practices conditions. 5.1.3Subtask 3 - Testing. The VA CSPCRPCC will conduct analytical testing on the NAC to verify it meets its specifications prior to certifying payment. 5.1.4Subtask 4 - Certificate of Analysis. A Moehs Certificate of Analysis will be provided either in advance or with the shipment which shows the NAC provided meets USP or more stringent specifications and Moehs release criteria. 5.1.5Subtask 5 - Material Safety Data. A current Material Safety Data summary must be provided either in advance or with the NAC shipment. 5.2Task 2 - Handling Customs Broker, Customs Clearance & Shipping Fees. Contractor's price will include the Customs Broker, Customs Clearance & shipping fees, including: "Shipping from the manufacturer (Moehs) to the U.S. Port of Entry "Shipping from the U.S. Port of Entry to the CSPCRPCC "Customs fees for Export/Import Duty "All Customs Broker fees associated with export/import 7.3Task 3 - Technical and Regulatory Support. Moehs, the API manufacturer, or the authorized U.S. distributor acting on behalf of Moehs, agree to provide updates to the DMF that relate to the NAC purchased by the CSPCRPCC. 7.4Task 4 - Inspection History. Contractor must provide documentation that either the FDA or the European Union (EU) Authorities conducted a recent, successful FDA or EU inspection of the facility in which the API, NAC, USP grade is manufactured, preferably for the manufacturing process used to manufacture the API, NAC, USP grade. 6.PERFORMANCE MONITORING. The CSPCRPCC will test the product to assure it meets the USP specifications upon receipt and prior to acceptance of the product. The CSPCRPCC will review the documentation required to assure it meets the requirements 9.SECURITY REQUIREMENTS. The C&A requirements do not apply and a Security Accreditation Package is not required. 10.GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI). Not Applicable 11.OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. a.Identification of Possible Follow-on Work. The CSPCRPCC does not anticipate any follow-on work to be required. b.Identification of Potential Conflicts of Interest (COI). The CSPCRPCC is not aware of any potential conflicts of interest. c.Identification of Non-Disclosure Requirements. The contractor will not have access to any proprietary VA information. d.Packaging, Packing and Shipping Instructions. Contractor's price will include the Customs Broker, Customs clearance & shipping fees, including: "Shipping from the manufacturer (Moehs) to the U.S. Port of Entry "Shipping from the U.S. Port of Entry to the CSPCRPCC "Customs fees for Export/Import Duty "All Customs Broker fees associated with export/import The API, NAC, USP grade will be shipped in an appropriate container that will not react with the NAC and under temperature conditions that will not impact the NAC stability. e.Inspection and Acceptance Criteria. Upon receipt and prior to acceptance, the CSPCRPCC will conduct analytical testing on the API, NAC, USP grade to assure it meets the USP specifications. The testing must be successfully completed prior to certifying payment. 12.RISK CONTROL. The API, NAC, USP grade will undergo appropriate testing upon receipt by the CSPCRPCC to assure there are no patient safety issues. The MOEHS Certificate of Analysis will be reviewed to assure the API, NAC, USP grade meets the USP specifications. 13.PLACE OF PERFORMANCE. The NAC will be shipped and delivered to the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center located at 2401 Centre Avenue, SE, Albuquerque, NM 87106. 14.PERIOD OF PERFORMACE. Need product in-house NLT March 1, 2014. 15.DELIVERY SCHEDULE. SOW Task #Deliverable TitleFormatNumberCalendar Days After CO Start 1API, N-Acetylcysteine, USP gradeBulk API in 50 Kg drumN/A52 2Handling: Customs Broker, Customs Clearance & Shipping FeesContractor-Determined FormatN/A52 3Technical and Regulatory SupportContractor-Determined FormatN/A52 4Inspection HistoryContractor-Determined FormatN/A52 *Standard Distribution: One copy of the transmittal letter without the deliverable to the Contracting Officer shall be emailed. 16.ACRONYMS. a.ANALYTICAL METHODS - Written procedures that document the different analytical tests that need to be conducted on API or finished product, the equipment required for each test, how to conduct each test, and the specifications the product results must meet for the material to be accepted for use. b.API - The active pharmaceutical ingredient in a dosage form or experimental drug that is expected to cure or minimize the symptoms of the disease the patient is experiencing. c.BIOEQUIVALENCE STUDIES - Studies conducted on healthy individuals to show that a formulated drug product creates the same biologic or chemical response in the human body as the formulated drug product to which it is being compared. d.BLINDED PRODUCT - Experimental drug and placebo manufactured so the experimental drug looks like the placebo and the patients cannot tell whether they are taking the experimental drug or the placebo. e.CLINICAL INVESTIGATOR - A medical researcher in charge of carrying out a clinical trial's protocol. f.CLINICAL TRIAL - A clinical trial is a research study to answer specific questions about vaccines or new therapies or ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. g.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. h.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. i.CSPCRPCC - Cooperative Studies Program Clinical Research Pharmacy Coordinating Center j.CUSTOMS BROKER - The Customs Broker prepares the documents and/or electronic submissions, the calculation (and the payment) on behalf of the client, of taxes, duties and excises, and facilitates the communications between the importer/exporter and governmental authorities. k.DISTRIBUTOR - Organization that serves as the authorized agent of the NAC manufacturer l.DMF - Drug Master File. The main objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND). m.DOSAGE FORM - Dosage form is a mixture of active pharmaceutical ingredient (API) and non-drug component, i.e., liquid dosage form, solid dosage form and semi-solid dosage form. n.DOUBLE-BLIND STUDY - A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental dosage form and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental dosage form do not affect the outcome. o.ENCAPSULATION - In the manufacture of pharmaceuticals, encapsulation refers to a range of techniques used to enclose medicines in a relatively stable shell known as a capsule. p.EU - European Authorities or the European equivalent of the U.S. Food and Drug Administration (FDA) q.FOOD AND DRUG ADMINISTRATION (FDA) - The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices. r.FORMULATION DEVELOPMENT - The research process for determining the dosage form ingredients, the amounts of the ingredients and manufacturing processes for adding the ingredients, mixing or blending them together and testing them to assure a tablet or capsule that meets the specifications for the dosage form is manufactured. s.GMPs - Good Manufacturing Practices. GMPs are used by pharmaceutical, medical device, and food manufacturers to produce and test products that people use. In the US FDA issues the GMP regulations as the minimum manufacturing requirements. t.IMPORT DUTY - Refers to the tax an importer must pay to the US Government in order to bring foreign products into the commerce of the United States. u.IND - Investigational New Drug. A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. v.INTERCHEM CORPORATION - the corporation that serves as the duly authorized distributor for NAC API manufactured by MOEHS. w.LETTER OF AUTHORIZATION - A document required by the Food and Drug Administration that is written by the API manufacturer. In the letter, the API manufacturer grants the FDA the right to review their Drug Master File on behalf of the organization submitting the IND (in this case the CSPCRPCC) to assure the API they manufacture is tested following GMPs. It assures that the tests meet the product specifications prior to shipment of the API. The manufacturer must also supply the CSPCRPCC with a signed original copy of the Letter of Authorization so the CSPCRPCC can include a copy with the IND submission. x.MOEHS - the company that manufactured the NAC API used in CSP578, the study for which this API is being purchased. y.NAC - N-Acetylcysteine. A pharmaceutical drug and nutritional supplement. z.PLACEBO - A placebo is dosage form that does not contain API and thus should not treat or minimize the illness the patient is experiencing. In clinical trials, experimental dosage forms containing API are often compared with placebos to assess the treatment's effectiveness. aa.POTENCY - The strength or amount of API in a dosage form. The specifications for the NAC potency of 90.0 to 110.0% are defined in the USP monograph for Acetylcysteine. The API product must meet the potency specifications through the expiration date. bb.SPONSOR - Person who initiates a clinical investigation, but who does not conduct the investigation. cc.STABILITY STUDIES - A study used to determine the length of time it takes a product to degrade to where it no longer meets its specifications. The product is typically stored at three different temperature and humidity conditions to stress the product and mimic different conditions the product might encounter throughout the world. Typically for API, tablets and capsules, multiple tests are conducted when the product is made. It is tested again at three and six months for the lowest and highest temperature conditions. It continues testing at 9, 12, 18, 24 and 36 month time points from the date of the initial testing for the expected storage condition. dd.USP - The United States Pharmacopeia is the official pharmacopeia of the United States. Pharmacopeia meaning literally, 'drug making,' is a reference work for pharmaceutical drug specifications. USP establishes written (documentary) and physical (reference) standards for medicines, food ingredients, dietary supplement products and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency. ee.VA - Veterans Affairs
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25814Q0240/listing.html)
 

Place of Performance

Address: Department of Veterans Affairs;VA Cooperative Studies Program Clinical;Research Pharmacy Coordinating Center;2401 Centre Avenue, SE;Albuquerque NM

Zip Code: 87106
 

Record

SN03302855-W 20140307/140305234703-1c771a9be54f0b3baefffefe80032bd7 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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