SOURCES SOUGHT
B -- Sterility and Endotoxin Testing and Validation
- Notice Date
- 8/6/2014
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- NIH-CC-P14-010969
- Archive Date
- 8/29/2014
- Point of Contact
- Lisa L. Schaupp, Phone: 3014020735
- E-Mail Address
-
Lisa.Schaupp@nih.gov
(Lisa.Schaupp@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Synopsis: The National Institutes of Health, Clinical Center is conducting a sources sought/market survey to help determine the availability and technical capability of qualified small businesses, women-owned small businesses, veteran-owned small businesses, service disabled veteran-owned small businesses and/or HUBZONE small businesses capable of serving the needs mentioned below. This sources sought/market survey announcement is not a request for proposals and the Government is not committed to award a contract pursuant to this announcement. The information from this market research is for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning this market research. The Government will not pay for any costs incurred in the preparation of information for responding to this sources sought/market survey. The Clinical Center, at the National Institutes of Health, intends to issue a solicitation for proposals for a firm fixed price Blanket Purchase Agreement (BPA) to provide the Department of Pharmacy, Pharmaceuticals Development Center (PDS) with a qualified vendor(s) to provide USP <71> Sterility Testing and USP <85> Endotoxin Testing for finished, sterile pharmaceutical products. The vendor must adhere to all applicable regulatory requirements including 21 CFR Part 211 Subpart I Laboratory Controls, and Subpart J - Records and Reports and provide PDS with a test report meeting these requirements. This is a fixed-price multiple award Blanket Purchase Agreement against which BPA calls will be issued. The applicable North American Industrial Classification System (NAICS) code is 541380 (small business size standard is $14 million dollars). The Clinical Center contemplates awarding up to five (5) BPAs, each for a five (5) year period. The NIH, Clinical Center Pharmacy Departments Pharmaceutical Development Section is seeking vendors that have a proven and established record of conducting the different types of Endotoxin tests as described in the USP 36, General Chapter <85>, Bacterial Endotoxin Test. In doing these tests the proper test method must be used depending on the nature of the product. The vendor would be expected to select the proper test from among the main types - Chromogenic, Turbidometric, Gel-clot or Glucan test. The vendor must also be able to do the validation tests for the various samples. This is a test to measure the amount of interference by the product with the test. The NIH, Clinical Center is also seeking vendors that have a proven and established record of conducting Sterility Tests as described in the USP 36, General Chapter <71> and as described in CFR 610.12. The vendor must also be able to do the validation tests for the various samples. This is a test to measure the amount of interference by the product with the test. A vendor is considered proven and established when they can demonstrate a significant presence and experience in regulated industries through past performance. Interested vendors must also be able to support with documentation that their business is conducted following recognized qualifications, such as being FDA registered and/or obtaining accreditation under ISO/IEC 17025 for testing laboratories. a) Specifications - Endotoxin testing Experience & Expertise - The vendor must have the experience and expertise necessary to do all the tests described in USP 36, General Chapter <85> and be able to document the Endotoxin Units per mL of the sample in a way that would be acceptable to FDA, IND reviewers. The product should be described by name and lot number and there should be a description of the reagents used to include lot numbers, a description of the reference standard used, a description of sample preparation and results in terms of EU/mL. Additionally, the vendor will have competence to recommend the correct type of endotoxin test. Service Needs - NIH will mail samples to the vendor. The vendor is required to deliver results within a maximum of 14 days of receiving a sample. b) Specifications - Sterility testing Experience & Expertise - The vendor must have the experience and expertise necessary to do all the tests described in USP 36, General Chapter <71> and 21 CFR 610.12 and be able to document the results of the test in a way that would be acceptable to FDA, IND reviewers. The vendor will take in to account the formulation vehicle and any preservative that may be present in developing the test procedure. The method used will be on the Certificate of Analysis (CoA). On the CoA the product should be described by name and lot number, the starting and ending date for the test and the report date. Service Needs - NIH will mail samples to the vendor. The vendor is required to deliver results within a maximum of 30 days of receiving a sample. c) Applicable Regulatory References 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals USP <71> Sterility Tests USP <85> Bacterial Endotoxins Test USP <797> Pharmaceutical Compounding - Sterile Preparations USP <151> Pyrogen Test USP<1163> Quality Assurance in Pharmaceutical Compounding Guidance FDA Guidance for Industry: Pyrogen and Endotoxin Testing: Questions and Answers d) The testing of sterile products is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any microorganisms that are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls. e) USP <1163> Quality Assurance in Pharmaceutical Compounding section on Testing states "If testing is outsourced, the compounder must be assured of the credentials, proper training, and continuing competency activities of the personnel in the contract laboratory." Additionally, the contract facility must adhere to the requirements of cGMPs and USP for a laboratory operating under these regulations in the testing of pharmaceutical components and products. This requires the testing facility to meet a number of requirements, including, but not limited to the following: The testing process must be controlled in such a manner as to be assured that it does not compromise test results. Such controls would include: • procedures for the receipt, handling and storage of customer's test samples • procedures to ensure all materials and components used in testing are of appropriate design and materials for purposes of conducting the required tests • aseptic practices of testing personnel • cleaning and disinfection practices of the test area • environmental monitoring of the test area • validation of sterility/depyrogenation cycles for test components and equipment • training of personnel in applicable written procedures All practices employed by the contract facility to meet these goals must be written procedures and adhered to under a quality system that provides for assurance in employee training and adherence to procedures and also provides a structure for completing investigations of testing failures. The vendor responses must demonstrate their expertise/experience in providing the services described above. Please note that failure to specifically demonstrate capability to provide the required services in your response to this sources sought/market survey may affect the Government's review of industry's ability to perform these services. The vendor's response shall be in sufficient detail to allow the Government to assess the capability of your firm. The vendor response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the company to perform the specialized requirements described in this synopsis. Interested organizations must demonstrate and document in any response submitted, to this sources sought/market survey extensive experience with and the ability to perform all of the specialized requirements elsewhere described. This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. THIS IS NOT A REQUEST FOR PROPOSALS. The Government will not award a Purchase Order or Contract based upon Vendor responses to this announcement. The Government shall not assume any costs for preparing or submitting any information in response to the sources sought/market survey or the Government's use of the information. Any proprietary information should be clearly identified as "Proprietary Information." Vendors must send written capability responses by 9:00 AM, July 25, 2014 to the Contract Specialist at the following e-mail address: lisa.schaupp@nih.gov. For any questions, please contact the Contract Specialist - Ms. Lisa Schaupp at (301) 402-0735. Contracting Office Address: 6707 Democracy Blvd, Suite 106, MSC 5480 Bethesda, Maryland 20892-5480
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/NIH-CC-P14-010969/listing.html)
- Place of Performance
- Address: Samples will be sent to vendors for testing at vendor laboratories. Results will be sent to:, NIH Clinical Center, Pharmacy Department, Pharmaceutical Development Section, Building 10,10 Center Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03452463-W 20140808/140807022253-5dd584d7a471c8706d17146cbcace3aa (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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