SOURCES SOUGHT
H -- Validation/Qualification of Repackaging Lines - List of equipment
- Notice Date
- 6/27/2013
- Notice Type
- Sources Sought
- NAICS
- 333993
— Packaging Machinery Manufacturing
- Contracting Office
- Department of Health and Human Services, Program Support Center, Supply Service Center, Building 14, Perry Point, Maryland, 21902
- ZIP Code
- 21902
- Solicitation Number
- 13-284-SOL-00005
- Archive Date
- 8/3/2013
- Point of Contact
- Allison C. Lempka, Phone: 410-642-0700, Leslie M. Lucas, Phone: 4106420701
- E-Mail Address
-
allison.lempka@psc.hhs.gov, leslie.lucas@psc.hhs.gov
(allison.lempka@psc.hhs.gov, leslie.lucas@psc.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- List of equipment This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to fill a potential requirement. HHS, Supply Service Center in Perry Point MD is seeking sources that can provide FDA mandated validation/qualification of three pharmaceutical packaging lines and processes. The current Good Manufacturing Practices (cGMP) regulations require the validation/qualification of all critical equipment and processes in all pharmaceutical operations including packaging. The scope of work includes creating and executing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as indicated in the attachments. This equipment shall be qualified by performing functional testing where the equipment is demonstrated to start and stop. This testing is referred to as "go/no go" or "pass/fail" indicating that it either works or does not work. This testing shall include preparation of the following documentation: 1). Protocols for testing and document verification of each individual piece of equipment. 2). Final summary reports for each individual piece of equipment. 3). Preparation of a summary document for each line stating the entire line to be validated. In addition, each protocol test shall be done three (3) times to demonstrate the process performs consistently and reproducibly. Total number of pieces of equipment is 27. All documentation must be approved by Perry Point management. All prospective vendors must meet all minimum specifications. It is incumbent upon all respondents to provide proper documentation ensuring the testing meets the minimum criteria. Responses must be received by July 19, 2013, 2:00 p.m. EST at the HHS, Supply Service Center, ATTN: Allison Lempka, Bldg. # 14, Perry Point, MD 21902. Faxed offers are acceptable; however it is the responsibility of the respondent to verify receipt of faxed documents. Responses may be faxed to: (410) 642-3566, ATTN: Allison Lempka. Respondents may also elect to transmit electronic copies to Allison.Lempka@psc.hhs.gov by the due date. Electronic copies must be in Adobe PDF format and it is the responsibility of the respondents to verify receipt of email copies. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitations may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY - No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/PSC/SSC/13-284-SOL-00005/listing.html)
- Place of Performance
- Address: Bldg. # 14, Perry Point, Maryland, 21902, United States
- Zip Code: 21902
- Zip Code: 21902
- Record
- SN03102245-W 20130629/130628001153-823c557ca79d9e2e52473b7308462937 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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